Careers

Careers

At Dicerna, we foster a culture of innovation through collaboration.

View our list of career opportunities.

 

We are dedicated to benefiting patients by advancing science and developing creative solutions to challenging therapeutic problems. Our core values of dedication, innovation, communication, excellence, respect, needs based and accountability drive us personally and as a team, and these are critical factors in the long-term success of our company.

We encourage open dialogue to identify and act upon novel ideas to meet the urgent needs of patients.

As innovators in the emerging area of RNAi, we seek forward-thinking talent to join our growing team, advance our robust pipeline of therapies, and provide ground-breaking medicines to those that depend on us.

Our office location in Cambridge underscores our commitment to being an employer of choice in the Massachusetts life sciences sector, and to being in close proximity to world-class research, academic and healthcare institutions as well as other life sciences leaders. We play an active role in the biotechnology community and in the Alewife business community as the area undergoes a revitalization to become a mini life sciences and technology hub. Our office is close to the MBTA subway and buses, the 120-acre Alewife Reservation, as well as many restaurants and services.

 

Dicerna is proud to be an Equal Opportunity Employer.

For interest in future employment opportunities, please submit your resume to Megan Garrapy at mgarrapy@dicerna.com.

 

Career Opportunities

  • Director, Toxicology

    Posted July 11, 2018

     

    Location:  Boulder, CO/Cambridge, MA

    We are seeking a Director, Toxicology to help advance the development of our growing pipeline of product candidates.  The individual in this position will participate on program development teams, and assist in the design and oversight of toxicology studies and preparation of regulatory submissions.

    Key Responsibilities

    • In conjunction with program teams, design and oversee conduct of external non-GLP investigative or GLP toxicology studies to support novel therapeutic agents through the drug development process
    • Serve as Study Monitor/Sponsor Representative for outsourced toxicology studies.  Review and provide feedback on related study protocols and reports
    • Contribute to the preparation of nonclinical components for regulatory submissions.
    • Collaborate on design of internal non-GLP investigative toxicity studies in support of development compounds as needed
    • Collaborate cross functionally with Research, Regulatory, Clinical and Manufacturing
    • Communicate toxicology data to Dicerna program teams and executive leadership as required

    Qualifications

    • Ph.D in a scientific discipline, toxicology related discipline preferred, with 5-10 years of pharmaceutical industry experience as a toxicologist
    • Experience with oligonucleotides preferred
    • Knowledge of global regulatory guidances (e.g. ICH and geography-specific) and Good Laboratory Practice (GLP) standards
    • Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation
    • Experience in developing toxicology programs to support early and later stage drug development and in preparing regulatory filings such as INDs/CTAs preferable
    • Effective organization skills and ability to work in a multi-tasking, fast-paced environment
    • Ability to work well in a team setting/matrix-type organization and to build strong cross-functional relationships
    • Some travel (domestic and international) will be required depending on project needs

    *** The right candidate will be considered for location in Cambridge, MA or Boulder, CO (area)

    Upload Résumé (We prefer PDF format)

  • Bioanalytical Chemist

    Posted March 6, 2018

     

    Overview 

    Dicerna is seeking an experienced Bioanalytical Chemist specializing in solving challenges in the analysis of molecular biomarkers and metabolites with a range of techniques and equipment. Experience in the bioanalysis and quantitation of oligonucleotides in biological matrices is a plus but is not required if balanced by a demonstrated breadth of bioanalytical experience. 

    Key Responsibilities 

    • Method development and quantitation of oligonucleotides in biological matrices including plasma, liver, and urine.
    • Operation and hands-on troubleshooting of multiple types of analytical instrumentation including HPLC, UPLC and LC-MS instruments.  
    • Method development for biomarker analysis.
    • Assist in the planning and management of contract research organizations and collaborations for the outsourcing of oligonucleotide bioanalysis. 
    • Technical support to non-clinical and clinical development activities including drafting and reviewing study reports for IND and CTA.

    Qualifications 

    • Ph.D. in Analytical Chemistry, Chemistry or Biochemistry with at least 3 to 5 years of relevant industrial experience in DMPK, biomarker and metabolite identification. 
    • Proficiency in mass spectrometry for metabolite profiling and identification.  
    • Experience with multiple types of analytical and chromatographic separation techniques, i.e. RP-HPLC, HILIC, SAEX and SEC. 
    • Strong computer skills and experience with software driven metabolite profiling is required. 
    • The successful candidate must be a resourceful and proactive individual who is able to work as a team player in a dynamic environment with tight deadlines. 

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  • Process Validation Manager

    Posted June 21, 2018

     

    As the Validation Manager you will provide validation services and expertise in support of clinical/commercial drug substance and drug product manufacturing. You will work closely with cross functional teams to ensure SOPs/validation policies are in compliance with industry practice and regulatory requirements.

     

    Key Responsibilities

    • Responsible for the planning, execution, and lifecycle maintenance of validation programs. Work with QA, regulatory, manufacturing, and process/analytical development to determine documentation for validation programs through all phases of product/process development, technology transfer and ultimately commercial manufacturing.
    • Oversee the development, execution, and reporting of validation protocols.
    • Ensure that validation plans, protocols, and regulatory summaries are conducted within approved timelines.
    • Ensure that the analysis of related protocols and report writing validation data are scientifically sound to support the process & product quality specifications within schedule parameters.
    • Develop, review, and approve documentation relating to equipment, cleaning, and processes as well as other subject matter areas as needed.
    • Write validation protocols as well as write comprehensive final reports including resolution of discrepancies, when applicable.
    • Support the review and approval of engineering and process development reports and specifications.
    • Conduct and approve validation assessments and risk analyses for equipment / systems and processes.
    • Review validation protocols, reports, data, plans, change controls, deviations and CAPAs for activities performed at CMOs.
    • Work with multidisciplinary teams to address deviations as well as recommend and implement corrective and preventative actions.
    • Contribute to the development of new or improved validation practices by identifying more efficient approaches to typical practices or problem scenarios.
    • Communicate validation requirements, timelines, and resource needs to senior management.
    • Travel percentage 25%

     

    Qualifications

    • Bachelor’s or Master’s degree in an engineering or scientific discipline with a minimum of 10 years of industry experience in a validation/quality role in the life sciences regulated industry.
    • Experience working in a cGMP environment and knowledge of ICH Q8, Q9, Q10 and FDA, ISO and cGMP regulations.
    • Application of risk based approach to validation (FMEA, PHA, etc.).
    • Knowledge of Validation Lifecycle Approach, such as ASTM E-2500.
    • Ability to perform basic statistical analysis of validation test results.
    • Strong technical writing and verbal communication skills – Clearly conveys information and concepts/principles.
    • Thorough understanding of cGxP and applicable regulations, ability to interpret and apply regulations to complex issues to make risk management recommendations.
    • Ability to perform basic statistical analysis of validation test results.
    • Ability to multi-task and work in a fast paced and dynamic environment.
    • Experience overseeing contract manufacturers.

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  • Director, Investor and Public Relations

    Posted September 11, 2018

     

    The Director, Investor and Public Relations will work directly with senior company executives to develop and implement Dicerna’s investor and public relations strategy. The position will be responsible for managing external relationships and assuring strong and consistent communication with the investment community including current shareholders, prospective shareholders, and financial analysts covering the company as well as serve as the company contact and spokesperson to the media.

     

    Key Responsibilities

    • Interact with the investment community on behalf of Dicerna and be proficient at communicating the company mission.
    • Establish and maintain excellent relations with institutional investors, key retail investors and analysts
    • Serve as the main point of contact for media
    • Develop, implement and manage strategic investor and public relations plans and manage the activities of agencies (IR, PR, etc.) working on behalf of Dicerna
    • Develop press releases, Q&A documents, messaging and other relevant materials to support public disclosures
    • Develop key communication materials in collaboration with senior leadership in preparation of analyst events, presentations, road shows, earnings releases and other announcements
    • Manage Dicerna’s corporate communications via the website and social media channels.
    • Update and continuously improve the website and social media efforts ensuring that key messages and communications are consistent.
    • Represent Dicerna at financial and industry conferences and medical meetings including coordinating meeting schedules and participating in one-on-one meetings with investors
    • Provide review and commentary on SEC filings including the annual report
    • Serve as key point of corporate communications to internal employees

    Qualifications

    • BA or BS required, MBA preferred
    • Minimum 10 years of experience working for a pharmaceutical/biotech company including experience in investor and/or public relations, corporate strategy, equity research, investment banking, finance or corporate communications
    • Stellar verbal and written communication skills, including impeccable presentation skills; proven ability to effectively interact with and present (verbally and in writing) to external and internal stakeholders. Demonstrated through a personable and energetic communication style with the ability to convey credibility.
    • Successful track record of interfacing with the investment community and media
    • Uncompromising ability to maintain confidentiality, exercise sound judgment and the highest level of discretion; knowledge of SEC and disclosure requirements preferred
    • Ability to demonstrate initiative and simultaneously achieve multiple tasks

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  • Senior Intellectual Property Attorney

    Posted July 6, 2018

     

    We are seeking a Senior IP Attorney to become a key member of Dicerna’s team. The successful candidate will have responsibilities in many areas of IP practice, including IP strategy development, patent portfolio management, freedom-to-operate analyses, partnering activities (including diligence and IP generation), competitive intelligence, trade secrets, trademarks, and R&D agreements. This is a great opportunity to join a growing company in an important position and work on exciting technology in a fast-paced environment.

    Key Responsibilities

     Help design and execute Dicerna’s IP strategy.
     Manage Dicerna’s patent portfolio in collaboration with the SVP, Legal Affairs.
     Work closely with research & development scientists as well as clinical staff to ensure that emerging technology is protected and developed into assets of the company’s IP estate.
     Manage outside counsel in the drafting and prosecution of patent applications.
     Draft patent applications.
     Evaluate and monitor outside IP estates and maintain awareness of competitors’ positions; identify IP of potential value to the company.
     Prepare for IP due diligence in support of business development activities.
     Conduct FTO searches and analyses.
     Actively participate in collaborations with outside parties.
     Participate in disclosure review.
     Manage Dicerna trademarks.
     Help design and enact IP policies and procedures internally.
     Assist with contentious matters such as litigations, post-grant proceedings, etc.
     Contribute to the development and review of R&D agreements (CDAs, MSAs, etc.).
     Participate in the training and education of scientific staff on IP principles.

    Qualifications

     B.S./M.S. in a scientific discipline
     Minimum of 5 years related experience as a patent attorney in the pharmaceutical/biotechnology industry. Prefer law firm and in-house experience
     Ability to perform independently with sufficient flexibility to handle a wide range of legal issues
     Ability to multi-task and prioritize workload
     Strong business acumen and understanding of drug development
     Strong client service focus to build and sustain effective partnerships with key stakeholders and project teams within the company
     Excellent interpersonal skills and oral and written communication skills

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  • Drug Product Manufacturing Manager

    Posted July 10, 2018

     

    Location: Boulder, CO Area

     

    Overview

    The successful candidate will be responsible for drug product manufacturing, and corresponding CMC regulatory activities.  This role requires thorough knowledge of cGMP for sterile pharmaceutical products.  This position will have significant cross functional interaction while supporting multiple projects. S/he will work closely with CMO’s and apply risk mitigation strategies to ensure the continuous supply of drug product.

     

    Key Responsibilities

    • Sterile Drug Product Manufacturing
    • Effectively manage ongoing projects and timelines
    • Provide risk assessment and supportive project planning
    • Support Investigations, corrective actions and CMC Regulatory submissions
    • Review of manufacturing records and analytical data as it pertains to the impact on the manufacturing process

     

     Qualifications

    • MS/BS in Biochemistry/Microbiology/Chemistry/Engineering or related discipline with 6 -10 years in a cGMP setting
    • In-depth experience in pharmaceutical engineering operations associated with aseptic processing
    • Experience working to standards required for national and international regulatory compliance of Aseptic Processing facilities
    • Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities and associated pharmaceutical processes
    • Experience with the drug product formulation process
    • Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems
    • Ability to perform risk assessments
    • Proficiency in generating and executing protocols and report
    • Experience in problem solving and continuous improvement technique
    • Ability to work independently as well as part of a team
    • Strong planning & organizational skills with the ability to prioritize and work within deadlines

     

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  • Scientist II / Senior Scientist, RNAi Pharmacology

    Posted July 18, 2018

     

    Dicerna is seeking a highly-motivated, experienced scientist to join our innovative team.  The ideal candidate will have a background in employing rodent models to perform multi-dimensional evaluations of experimental molecular therapeutics (PK/PD/efficacy).  The candidate will be an integral part of our cross-functional R&D team, with a key role in expanding our discovery pipeline and enabling the success of strategic alliances with pharma partners.  The candidate will also contribute to IND/CTA filings and business development activities.

     

    Key Responsibilities

    • Project leadership: perform innovative and challenging science to meet milestones
    • Pharmacodynamic and pharmacokinetic characterization of novel experimental RNAi therapeutics in rodents, and generation of molecular endpoint data
    • Development or implementation of rodent disease/phenotypic models to achieve therapeutic proof-of-concept
    • Collaboration with discovery biologists and medicinal chemists for platform development and lead optimization; interface with external partners
    • Pharmacology support for nonclinical and clinical-stage pipeline programs
    • Generation and communication of study reports, data packages, SOPs and related documentation

     

    Qualifications

     Ph.D. (or MS+10) in Biology, Pharmacology, Biochemistry, Pharmaceutical Sciences or equivalent

    • Expertise in rodent pharmacology including study design, dosing, necropsy, tissue processing; strong molecular biology and assay development/implementation skills (examples, but not all necessarily required: qPCR, NGS, FACS, Western/ELISA, IHC/histology).  Working knowledge of drug discovery processes, SAR and PK/PD concepts
    • Commitment to scientific rigor, high data quality and careful documentation
    • Expertise in metabolic diseases, immunology, kidney or CNS biology is a plus, but a broad range of backgrounds will be considered.  Demonstrated scientific track record is required
    • Ability to interact effectively on multidisciplinary teams and participate in our exciting, dynamic company culture
    • Ability to multitask, prioritize and manage timelines, manage projects and/or people.
    • Strong scientific writing skills, and experience in delivering effective scientific presentations to internal or external teams
    • Experience or working knowledge in nucleic acid therapeutics is a plus

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  • Clinical Project Manager

    Posted August 1, 2018

     

    We have several openings for Clinical Project Managers in our Clinical Development Operations Development group.

    This is a unique opportunity to work in a growing department that manages multiple early-stage clinical programs based on an innovative RNAi technology platform.

     

    Position Description

    We are looking for several passionate and collaborative individuals who will be responsible for all aspects of clinical trial management aimed at treating a rare or infectious liver-targeted disease.    You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.

     

    Responsibilities:

    • Oversee performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate.
    • Collaborate with the Clinical Program Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study objectives.
    • Develop study plan(s) including key milestones and timelines.
    • Ensure country and site selection meet study requirements.
    • Participate in development and testing of clinical systems (e.g., data capture, IxRS).
    • Ensure internal and external systems are updated in a timely manner (e.g., trackers, clinicaltrials.gov).
    • Manage critical study documents, such as consent forms, study manuals, subject recruitment materials.
    • Oversee the Trial Master File and assist with periodic audit of the TMF.
    • Drive critical clinical trial activities including trial site activations, recruitment, and database lock.
    • Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting.
    • Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally.
    • Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points.
    • Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation.
    • Provide input in internal/external study related audits, review resulting reports.
    • Review monitoring reports and, if applicable, corrective action plans at individual sites and provide oversight to ensure safety concerns are identified and responses developed.
    • Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders.
    • Represent Dicerna during site initiation visits, trainings, close out visits, and conduct co-monitoring visits as needed.
    • Train study team members, external monitors, and site staff as needed.

     

    Requirements:

    • BSN or Bachelor’s Degree in scientific discipline or health-related field
    • Minimum 5 years clinical development experience in industry with at least 2 years as trial manager
    • Experience with global clinical trial operations, in multiple phases of research
    • Strong knowledge of GCP, ICH and FDA regulations
    • Experience with all aspects of trial and site startup and vendor management
    • Ability to deal with multiple priorities having aggressive timelines with attention to detail
    • Ability to find creative solutions to issues impacting timelines and budgets
    • Willingness to travel up to 20%, domestically and internationally
    • Proficient in MS Office (Excel, PowerPoint and Word)
    • Experience in Rare Disease, Pediatric, and/or complex clinical trials preferred

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  • Clinical Trial Associate

    Posted August 1, 2018

     

    We are seeking a highly organized and detail oriented Clinical Trial Associate (CTA) to assist with the execution of clinical trials.

     

    Key Responsibilities

    • Support clinical development team in the overall management of studies, including planning, execution and closeout of outsourced clinical trials.
    • Assist Clinical Project Manager in site management activities: could include review of monitoring report, tracking of site visits, and communication with monitors and sites.
    • Work closely with clinical project managers to assist with preparation of all external and internal documentation for assigned trials to ensure it’s completed in accordance with GCP regulatory requirements and consistent with the study protocol.
    • Assist in the creation of and distribution of study materials and communications to KOLs, CROs and other external vendors.
    • Organize and prepare study files related to study tracking and reporting and submit them to the Trial Master File within established guidelines, maintain up-to-date documentation for all study sites globally.
    • Assist the project team with planning, preparation and possible on-site support of investigator’s meetings.
    • Support invoice and budget activities

     

    Qualifications

    • Bachelor’s degree with a life science or healthcare focus
    • A minimum of 2+ years of supporting clinical studies at a hospital, CRO or biopharma company
    • Strong interpersonal, organizational and multi-tasking skills; attention to detail
    • Working knowledge of ICH GCP regulations and clinical protocols
    • Sound analytical and problem- solving skills; ability to act with a consistent sense of urgency

     

     

     

     

     

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  • Scientist – Translational Biology

    Posted August 21, 2018

     

    We are seeking a highly skilled scientist to play a prominent role in guiding creative and rigorous biological research programs aimed at fully understanding the disease mechanism of Dicerna’s pipeline

    This individual will apply his/her expertise and deep understanding of molecular and cellular biology to study liver diseases and play a key role in all phases of drug discovery and clinical development at Dicerna.

     

    Key Responsibilities

    • Investigate liver diseases to lead mechanism of action and pharmacology studies on Dicerna’s GalXC therapeutics.
    • Develop in vivo model systems and technologies to evaluate efficacy, pharmacodynamics, and mechanisms of action of drug candidates
    • Using appropriate in vivo models, lead internal and external research efforts to understand the mechanisms by which our drug candidates may contribute to adverse events in patients
    • Design and execute comprehensive in vivo and in vitro studies to understand disease mechanisms and therapeutic hypothesis.
    • Develop high quality technical reports and summaries for internal use and inclusion in key Regulatory documents (e.g. INDs and NDAs).
    • Design and manage in vivo studies on pre-clinical and clinical candidates, conduct hands-on research, interacting closely across functional groups.
    • Work closely with internal research team, external collaborators, and contract research organizations (CROs) to develop in vivo strategies to rapidly and effectively address key questions related to the safety and efficacy of our drugs, with actionable results.
    • Review literature and provide insights to research directions, while also making hands-on contributions to the research.
    • Regularly present work progress to rest of company.

     

    Qualifications

    • PhD in Biology, Pharmacology, biochemistry, molecular biology or related field, with 0-5 years of industry experience
    • Broad and deep understanding of signaling pathways and biological processes implicated in genetic diseases, and the mechanisms of action of RNAi therapies is preferred
    • In depth knowledge of, and hands-on experience with, in vitro and in vivo models used for mechanistic investigation of liver biology and toxicity, and identification of biomarkers
    • Experience performing molecular and cellular biology techniques including but not limited to RNA preparation, RT-qPCR, ELISA, immunohistochemistry, urine biomarker analysis, plasma biomarker analysis
    • Demonstrated record of accomplishment throughout your career
    • Strong publication record
    • Outstanding written and oral communication skills
    • The ability to work effectively as part of a team, in a fast-paced environment
    • Experience managing more junior staff is desirable

    Upload Résumé (We prefer PDF format)

  • Sr. Manager/Manager Drug Safety and Pharmacovigilance

    Posted August 21, 2018

     

    This is a part-time position in Drug Safety and Pharmacovigilance (DSPV) which report to the CMO. He/she will perform periodic safety signaling, as well as perform individual and aggregate case review with support from an external partner. The successful candidate will provide adequate Sponsor oversight for all drug safety and pharmacovigilance activities for all Dicerna sponsored clinical studies.

     

    Key Responsibilities

    • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
    • Participate in preparation of Informed Consent Forms to ensure that adequate safety information is provided to study participants.
    • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
    • Ensure compliance with worldwide regulations for the reporting of adverse events.
    • Monitor activities of CROs/business partners to ensure adherence and compliance with applicable Safety Monitoring Plans and other contractual agreements.
    • Collaborate with Medical Director and CMO, as well as Clinical Development Operations and vendor clinical staff who provide medical and/or monitoring support for ongoing clinical trials
    • Participate in the cross-functional program team meetings and safety oversight meetings that manage the overall benefit/risk profile of the compound.
    • Contribute to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
    • Contribute to preparation and review of responses to health authority queries as well oversee aggregate safety reports such as Development Safety Update Reports (DSURs) and Periodic Benefit/Risk Evaluation Reports (PBRERs) in collaboration with external safety vendor
    • Support the completion of Clinical Safety Reports (CSRs) by reviewing safety data, patient narratives, and safety sections of the documents.
    • Contribute as needed to the preparation for Data Safety Monitoring Board meetings.
    • Leads PV inspection readiness with the CMO and coordinates global inspection readiness activities for PV inspections of global products.
    • Provide Safety Reporting training at investigator meetings

     

    Qualifications

    • Master’s degree in relevant field (e.g. Life sciences) or equivalent combination of education and experience.
    • 5 years’ experience in Pharmacovigilance compliance in the pharmaceutical industry.
    • Prior experience contributing to protocol, IB, and ICF development/updating
    • Prior experience writing CSRs.
    • Knowledge of ICH, US & EU regulations and requirements for Pharmacovigilance.
    • Willingness to be very “hands-on” in a fast-paced work environment.
    • Experience working with vendors is strongly preferred.

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  • Research Associate/Senior Research Associate – Translational Biology

    Posted August 22, 2018

     

    We are seeking a highly skilled research associate to lead mechanism of action and pharmacology studies on Dicerna’s GalXC therapeutics. Major responsibilities include conducting in vivo studies on our pre-clinical and clinical candidates and conducting hands-on research. You will apply your expertise on animal dosing and surgery and deep understanding of the molecular and cellular biology to study liver diseases and play an important role in all phases of drug discovery and clinical development at Dicerna.

     

    Key Responsibilities

    • Play a role in guiding creative and rigorous biological research programs aimed at fully understanding the disease mechanism of Dicerna’s pipeline.
    • Conduct efficacy, pharmacokinetic, pharmacodynamics, structure-activity-relationship and mechanisms of action studies of drug candidates
    • Use appropriate in vivo models to understand the mechanisms by which our drug candidates may contribute to adverse events in patients
    • Present working progress to team members in group meeting
    • Work closely with members of Dicerna’s research team to develop in vivo strategies to quickly and effectively address key questions related to the safety and efficacy of our drugs.
    • Review literature and provide insights to research directions, while predominantly making hands-on contributions to the research

     

    Qualifications

    • Bachelor’s or Master’s Degree in Biology, Pharmacology, or related field, with a minimum of 5-10 years of experience.
    • Proficient in animal handling, dosing and surgery. Proficient in techniques including but not limited to oral gavage, intravenous injection, subcutaneous injection, blood collection and basic surgery
    • In depth knowledge of, and hands-on experience with, in vitroand in vivo models used for mechanistic investigation with small molecule or RNAi therapeutics
    • Experience performing molecular and cellular biology techniques, including but not limited to RNA preparation, RT-qPCR, ELISA, immunohistochemistry, urine biomarker analysis, plasma biomarker analysis
    • Broad and deep understanding of signaling pathways and biological processes implicated in rare genetic liver diseases as well as the mechanism of action of RNAi therapies is desirable
    • Previous experience in drug discovery is preferred
    • Outstanding written and oral communication skills
    • A high level of motivation and demonstrated record of accomplishment throughout your career
    • The ability to work effectively as part of a team, in a fast-paced environment

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  • Director, Program Development

    Posted August 27, 2018

     

    Location:   Boulder, CO/Cambridge, MA

     

    The Director, Program Development is an experienced professional with demonstrated ability to manage drug development programs ranging from early to late stages.  The individual will be responsible for managing Dicerna development programs and enable successful completion of program milestones and corporate goals.  This role is highly cross-functional and may involve close interaction with external partners.

     

    Key Responsibilities

    • Serve as program manager for Dicerna development programs and provide leadership, coordination, and cross-functional communication to enable teams to meet goals. This includes:
    • Leading and participating in development and subteam meetings
    • Applying program management best practices in the development, initiation, tracking, planning, execution, and control of programs.
    • Performing administrative tasks including creation and maintenance of program plan documents, meeting scheduling and facilitation, and developing and tracking detailed program budgets
    • Coordinate with other program managers to ensure document continuity, assign appropriate resource allocation, and improve Development team processes.
    • Collaborate cross functionally with Research, Regulatory, Quality, Nonclinical, Clinical and Manufacturing to facilitate information flow and communication between all stakeholders and to ensure execution of program strategy
    • Identify and creatively facilitate resolution of issues adversely impacting programs
    • Compile appropriate metrics, tracking reports and provide updates to senior management to ensure programs are adequately resourced to meet strategic objectives
    • Provide program management support to the rest of the organization as requested

     

    Qualifications

    • BS degree in a science discipline with a minimum of 10 years relevant experience or an MS/Ph.D. with 8 years relevant experience
    • Previous experience managing drug development programs, experience with late stage programs a plus
    • Knowledge of global regulatory guidances (e.g. ICH and geography-specific) and Good Laboratory Practice (GLP) standards
    • Experience preparing regulatory filings such as INDs/CTAs/NDAs
    • Proficiency with Microsoft Office including Microsoft Project
    • Demonstrated ability to translate strategy into action
    • Ability to find creative solutions to issues impacting timelines and budgets
    • Ability to analyze and communicate complex issues, develop plans, programs and recommendations
    • Excellent organizational and communication skills – both oral and written
    • Highly collaborative team player who fosters open communication and develops important relationships with key stakeholders
    • Ability to lead cross-functional drug development
    • Ability to use collaborative technology to lead virtual meetings and work with team members around the world
    • Must be able to effectively organize and multi-task in a fast-paced environment
    • PMP certification would be a plus, but is not required
    • Some travel (domestic and international) will be required depending on program needs

     

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  • Nonclinical Writer

    Posted August 27, 2018

     

    Location:    Cambridge, MA or Boulder, CO

     

    The Nonclinical Writer will be a key member of the Program Development Team and will work closely with Nonclinical and ADME to manage all aspects of preparation for regulatory documents according to company guidelines and international governmental regulations. The individual will provide strategic direction to cross-functional teams to ensure that key messages are consistently aligned with reporting requirements and company objectives.

     

    Responsibilities  

    • Plan, prepare, write, edit, format, and finalize nonclinical and ADME regulatory documents. Documents will include, but are not limited to: IND, CTA, summaries and updates to regulatory submissions, annual reports/development safety update reports (DSURs) etc.
    • Work with program development teams and the medical writing staff to assist in developing strategy for organizing and preparing documents for regulatory health authority submissions
    • Coordinate the internal review of nonclinical documents
    • Develop, maintain, and drive document finalization timelines
    • Ensure final documents adhere to internal standard operating procedures (SOP) and the International Council on Harmonisation (ICH)
    • Perform quality control review of writing documents
    • Assist in general document formatting and word processing as needed
    • Assist in the development of templates, style guidelines, and SOPs for documentation

     

    Requirements

    • Minimum requirement of a bachelor’s degree with 4+ years of nonclinical writing experience in a pharmaceutical/biotechnology or CRO environment
    • Ability to interpret and present non-clinical data objectively in a clear, concise format
    • Outstanding written and oral communication skills
    • Proficiency in teamwork, organization, and project management
    • Proficiency in MS Office

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  • Scientist, RNAi Discovery/Bioinformatics

    Posted September 10, 2018

     

    Dicerna Pharmaceuticals is looking for a PhD scientist to help in its drug discovery efforts. This is a hands-on research position that requires strong expertise in molecular and cellular methodologies. Responsibilities will entail a combination of bioinformatics and drug discovery work. This is a full-time position. Dicerna offers an exciting work environment and strong team culture. Our company has a competitive benefits package and bonus incentive program.

    Key Responsibilities

    • Computational Biology analyses (e.g. RNA-seq data analysis); development and implementation of novel algorithmic tools for drug candidate screening
    • siRNA drug candidate screening, hit identification, and lead optimization
    • Cellular and molecular biology methodologies, e.g., mammalian cell culture; in vitro screening; cell-based assays; PCR

    Qualifications

    • PhD in a relevant field and 0-5 year’s postgraduate experience, preferably in drug discovery and in an industry setting.
    • Experience in informatics is required (e.g. next-gen sequencing data analysis; informatics tool development; data mining; with expertise in R and R:Bioconductor suite, Python, PERL and/or PHP preferred).
    • Expertise in statistical analysis is strongly preferred.
    • Expertise in cellular and molecular biology is essential (e.g., mammalian cell culture; cell-based assays; quantitative real-time PCR)
    • Experience with RNAi is preferred.
    • The individual should have strong oral and written communication skills and a demonstrated ability to contribute effectively to group projects in a team-oriented environment.
    • Ability to perform and interpret experiments reliably, and to advance projects aggressively towards defined goals is expected.

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  • Research Associate, RNAi Discovery

    Posted September 10, 2018

     

    Dicerna Pharmaceuticals is looking for a BS/MS scientist to help in its drug discovery efforts. This is a hands-on research position that requires strong expertise in molecular and cellular methodologies.  This is a full-time position. Dicerna offers an exciting work environment and strong team culture. Our company has a competitive benefits package and bonus incentive program.

     Key Responsibilities

    • siRNA drug candidate screening, hit identification, and lead optimization
    • Cellular and molecular biology methodologies, e.g., mammalian cell culture; in vitro screening; cell-based assays; PCR
    • In vivo drug candidate testing (e.g. mouse dosing; sample analysis

     Qualifications

    • BS/MS in a relevant field and 0-5 year’s postgraduate experience, preferably in drug discovery and in an industry setting (junior or senior candidates considered, with level and compensation commensurate with experience)
    • Expertise in cellular and molecular biology is essential (e.g., mammalian cell culture; cell-based assays; quantitative real-time PCR)
    • Experience with RNAi is preferred; experience with in vitro screening is preferred.
    • Experience with in vivo methodologies is desirable (e.g. mouse handling; dosing; sample analysis; histology).
    • The individual should have strong oral and written communication skills and a demonstrated ability to contribute effectively to group projects in a team-oriented environment.
    • Ability to perform and interpret experiments reliably, and to advance projects aggressively towards defined goals is expected.

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  • Toxicology Study Manager

    Posted September 10, 2018

     

    Location:  Boulder, CO/Cambridge, MA

    We are seeking a Toxicology Study Manager to help advance the development of our growing pipeline of product candidates. The individual in this position will assist in the oversight of toxicology programs by serving as the Sponsor Representative for studies conducted at external contract research organizations (CRO).

    Key Responsibilities

    • Responsible for management, operational oversight, and may be involved with on-site monitoring of toxicology studies conducted at CROs
    • Serve as the point person for managing study communications, activities, and documents from Request for Proposal (RFP) to study closure. This includes keeping team electronic file storage sites up to date.
    • In partnership with the Study Monitor/Toxicologist, contribute to study designs, protocol development, and written reports. Draft CTD tables from study data.
    • Facilitate review and compilation of feedback from stakeholders for study related documentation. Provide QC of tables and reports as needed.
    • Work closely with CROs to ensure that all studies are performed in a high quality and timely manner in order to meet program goals
    • Facilitate study-related shipments and data transfer
    • May participate in CRO evaluation and qualification
    • May contribute to the preparation of nonclinical components for regulatory submission
    • Collaborate cross functionally with Research, Regulatory, Clinical, and Manufacturing and relevant program team
    • Communicate toxicology timelines and data to stakeholders as needed
    • Some travel (domestic and international) will be required depending on project needs

     

     Qualifications

    • B.S. in a scientific discipline, toxicology-related discipline preferred, with 3-5 years of pharmaceutical industry or CRO experience
    • Experience with oligonucleotides preferred but not required
    • Knowledge of global regulatory guidances (e.g. ICH and geography-specific) and Good Laboratory Practice (GLP) standards
    • With attention to detail, ability to critically evaluate all study documentation (eg. protocols, data, reports)
    • Ability to determine test article needs and calculate or confirm dosing solution calculations
    • Effective organization skills and ability to work in a multi-tasking, fast-paced environment
    • Use skills of persuasion and diplomacy to resolve issues impacting studies
    • Goal oriented, highly self-motivated and self-directing individual who enjoys working in different environments and multiple capacities
    • Ability to work well in a team setting/matrix-type organization and to build strong cross-functional relationships
    • Enthusiasm for meeting program timelines and goals

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  • Data Manager

    Posted September 10, 2018

     

    Overall responsibilities will include oversight of clinical data management (CDM) activities for the entire Dicerna clinical portfolio. The successful candidate will proactively oversee CDM execution of CRO outsourced trials from study startup through study closure in support of trial objectives and corporate goals. This position reports to the Director of Biometrics.

    Key Responsibilities

    • Provide oversight of clinical data management activities across multiple studies.
    • Collaborate with clinical study teams and vendors to meet project deliverables, including data acquisition, quality checking and reporting in compliance with GCP, SOPs and regulatory requirements.
    • Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans – identifying and mitigating risks to data quality.
    • Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality.
    • Participate in selection of CROs and vendors; review proposals and make award recommendations
    • Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.
    • Ensure completeness, accuracy and consistency of clinical data across all assigned studies.
    • Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel.
    • Report query trends and data/query metrics to the study team.
    • Review data transfers for consistency with available specifications, e.g. SDTM specifications, annotated CRFs.
    • Represent data management at Investigator Meetings and may present EDC and Case Report Forms to investigators.
    • Implement, track and review key performance indicators on data entry, source verification, and query status; perform quality control on those metrics to ensure accuracy.
    • Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
    • Review draft TFL output prior to final database locks.
    • Contribute to the development of data standards in compliance with CDISC (CDASH/SDTM), and corresponding standard edit checks and data review listings.
    • Participate in the review and/or development of SOPs and working practices.

    Qualifications

    • BS/BA in Life Science or related discipline
    • 5+ years of clinical data management experience in the pharmaceutical/CRO industry.
    • 5+ years of Electronic Data Capture (EDC) experience
    • Global clinical trial and CRO management experience
    • Strong working knowledge of FDA & ICH/GCP regulations and guidelines
    • Strong working knowledge of CDISC standards (CDASH and SDTM) and CDM Best Practices.
    • Experience with SAS or SQL programming techniques with clinical data management application a plus.
    • Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment

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  • Sr. Quality Assurance Specialist

    Posted September 10, 2018

     

    Dicerna is looking for a Sr. Quality Assurance Specialist who will manage and oversee the Document Management System, Training System and other QMS as deemed required for execution and maintenance (data entry, reporting, filing, archival) of the assigned quality system. Acts as technical resource for Quality while tracking and trending of investigation/resolutions of Corrective and Preventive Actions (CAPA) and deviations.  They also must have a working knowledge of QMS and its responsibilities and be a self-starting problem solver who drives results through high compliance and a positive work style ensuring quality activities are carried out according to the regulatory requirements.

    Key Responsibilities

    • Ensure quality activities are carried out according to the regulatory requirements.
    • Manage and oversee the Document Management System, Training System and other QMS as deemed required.
    • Track the investigation/resolution of Corrective and Preventive Actions (CAPA) and deviations.
    • Has a working knowledge of QMS and its responsibilities.
    • Be a self-starting problem solver who drives results through high compliance and a positive work style.
    • Manage and oversee the Document Management System that would include Edit document formatting without changing content to ensure consistency across documents.
    • Coordinate workflows with task owners to ensure that documents are properly reviewed, issued, approved, and obsoleted within needed timeframes.
    • Follow up with others to ensure that records are completed and documented within established timeframes.

    Qualifications

    • BS/BA in science related field or equivalent experience with 5 + years of related Quality Assurance experience.
    • 3-5+ years of document management experience in a Quality Assurance related function.
    • Knowledge of GLP, GMP, GCP, Part 11 regulations, FDA Guidances for Industry, EU regulations, and other standards.
    • Strong proofreading and document formatting skills which must include processing of controlled documents (new documents, revision, obsolescence, etc.)
    • Strong problem solving/analytical skills.
    • Knowledge of Microsoft Office® applications and spreadsheet programs such as Excel, Word, Power Point, and Microsoft Project.
    • Excellent abilities with intermediate MS office concepts such as Word Styles, cross-references, keep with next, section breaks, freeze panes, header/footer and others
    • The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism.
    • Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail are equally important.
    • The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
    • Strong organizational skills, with the ability to handle multiple tasks.

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  • ADME Manager

    Posted September 14, 2018

     

    Location: Boulder, CO/Cambridge, MA

    We are seeking an ADME Manager to help advance the development of our growing pipeline of product candidates.  The individual in this position will assist in the oversight of bioanalytical studies conducted at external contract research organizations (CRO).

    Key Responsibilities

    • Responsible for management, operational oversight, and may be involved with on-site monitoring of bioanalytical studies conducted at CROs
    • Serve as the point person for managing study communications, activities, and documents from Request for Proposal (RFP) to study closure. This includes keeping team electronic file storage sites up to date.
    • In partnership with the nonclinical team, contribute to study designs, protocol development, and written reports. Draft CTD tables from study data.
    • Facilitate review and compilation of feedback from stakeholders for study related documentation. Provide QC of tables and reports as needed.
    • Work closely with CROs to ensure that all studies are performed in a high quality and timely manner in order to meet program goals
    • Facilitate study-related shipments and data transfer
    • May participate in CRO evaluation and qualification
    • May contribute to the preparation of nonclinical components for regulatory submissions
    • Collaborate cross functionally with Research, Regulatory, Clinical, and Manufacturing and relevant program team
    • Communicate bioanalytical timelines and data to stakeholders as needed
    • Some travel (domestic and international) will be required depending on project needs

    Qualifications

    • S. in a scientific discipline, bioanalytical or ADME-related discipline preferred, with 5-7 years of pharmaceutical industry or CRO experience
    • Experience with oligonucleotides preferred but not required
    • Knowledge of global regulatory guidances (e.g. ICH and geography-specific) and Good Laboratory Practice (GLP) standards
    • With attention to detail, ability to critically evaluate all study documentation (e.g. protocols, data, reports)
    • Ability to determine test article needs and calculate or confirm solution calculations
    • Effective organization skills and ability to work in a multi-tasking, fast-paced environment
    • Use skills of persuasion and diplomacy to resolve issues impacting studies
    • Goal oriented, highly self-motivated, and self-directing individual who enjoys working in different environments and multiple capacities
    • Ability to work well in a team setting/matrix-type organization and to build strong cross-functional relationships
    • Enthusiasm for meeting program timelines and goals

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  • Director of Biostatistics

    Posted September 17, 2018

     

    Reporting to the Senior Director of Clinical Development, the Director of Biostatistics acts as statistical lead across all of Dicerna’s drug development programs. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Leads biometrics focused regulatory interactions and submissions to the FDA and other regulatory agencies; Coordinates the biometrics effort across the different programs to identify, develop and implement departmental standards, applications, processes, and training.

    Key Responsibilities

    • Contribute in study level tasks from statistics perspective, including but not limiting to: study design and sample size determination; author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files; develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings.
    • Lead in product level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from the statistics perspective.
    • Work collaboratively with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
    • Oversee statistical work by CRO and ensure quality deliverables with respect to key performance indicators, metrics, and program level deliverables and timelines.
    • Translate statistical thinking into a strategic input to advance the clinical program.
    • Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
    • Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements.
    • Lead in developing department standards and research in advanced statistical methodologies.
    • Author/review regulatory documents or scientific publications.
    • Contribute to project budget/resource planning, re-forecasting, and program milestones.

    Qualifications

    • PhD in Statistics, Biostatistics or Mathematics with a minimum of 7-10 years (minimum 10 years for master’s degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
    • Led in NDA/BLA/MAA activities from a statistics perspective and experienced in direct regulatory interaction and experienced in regulatory inspections
    • Adept at outsourcing and managing biostatistical services provided by CRO’s and contractors.
    • Experienced as product lead statistician and contribute to strategy discussion in cross-functional settings; Experienced in managing multiple products and studies and being able to prioritize.
    • Experienced in study level work including authoring SAP and TFL specification
    • Develop SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays.
    • Lead development of department SOPs.
    • Familiar with ICH guideline, FDA/EMA/other regulatory authority guidance.
    • Solid understanding of mathematical and statistical principles; Experience in statistical methods (longitudinal data analyses, Bayesian method, adaptive design) is preferred.
    • Excellent communication and interpersonal skills, with the ability to translate statistical concepts to program strategies.
    • Detailed-oriented with organization, problem-solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline.
    • Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies.

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  • Scientist, RNAi Discovery

    Posted September 19, 2018

     

    Dicerna Phamaceuticals is looking for a PhD scientist to help in its drug discovery efforts.  This is a hands-on research position that requires strong expertise in molecular and cellular methodologies. This is a full-time position. Dicerna offers an exciting work environment and strong team culture. Our company has a competitive benefits package and bonus incentive program.

    Key Responsibilities

    • siRNA drug candidate screening, hit identification, and lead optimization
    • Cellular and molecular biology methodologies, e.g., mammalian cell culture; in vitro screening; cell-based assays; PCR
    • In vivo drug candidate testing (e.g. mouse dosing; sample analysis)

    Qualifications

    • PhD in a relevant field and 0-5 year’s postgraduate experience, preferably in drug discovery and in an industry setting
    • Expertise in cellular and molecular biology is essential (e.g., mammalian cell culture; cell-based assays; quantitative real-time PCR)
    • Experience with RNAi is preferred
    • Experience with in vivo methodologies is desirable (e.g. mouse handling; dosing; sample analysis; histology)
    • The individual should have strong oral and written communication skills and a demonstrated ability to contribute effectively to group projects in a team-oriented environment
    • Ability to perform and interpret experiments reliably, and to advance projects aggressively towards defined goals is expected

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  • ADME Research Associate

    Posted September 21, 2018

     

    We are seeking an ADME Research Associate to help advance the development of our growing pipeline of product candidates.  The individual in this position will assist in the conduct of Absorption, Distribution, Metabolism, and Excretion studies and perform other tasks to support nonclinical development.

    Key Responsibilities

    • Biological sample preparation for analysis (blood, urine, tissues, and cells)
    • Sample analysis using quantitative techniques (PCR, ELISA, liquid chromatography)
    • Management and interpretation of experimental data, with appropriate documentation
    • Preparation of solutions
    • Manage shipments of samples and test articles for external studies
    • Manage nonclinical sample archive
    • Perform QC of nonclinical data and reports
    • May contribute to the preparation of nonclinical components for regulatory submissions

    Qualifications

    • S./M.S. in a scientific discipline, pharmacology, chemistry, biochemistry, biology or related discipline preferred, with 1-3 years of pharmaceutical industry or CRO experience
    • Experience performing molecular biology techniques and liquid chromatography
    • Experience with oligonucleotides preferred but not required
    • Proficient in MS Office (Word, Excel, PowerPoint)
    • Strong verbal and written communication skills, as well as attention to detail
    • Effective organization skills and ability to work in a multi-tasking, fast-paced environment
    • Enthusiasm for meeting program timelines and goals, as well as ability to learn new techniques and methodologies

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  • Director, Alliance Management

    Posted September 25, 2018

     

    We are seeking a Director/Senior Director, Alliance Management to become a key member of Dicerna’s team and contribute to our program and business development efforts. The successful candidate will have significant responsibilities in several areas of alliance management with a focus on specific collaborations. This is a great opportunity to join a growing company in a key position and contribute to our development of important therapeutics.

    Key Responsibilities

    • Develop an alliance management practice across the company to help maximize current and future business relationships and opportunities.
    • Execute alliance governance processes and protocols through dialogue within Dicerna and with partners.
    • Partner closely with team leadership to ensure Dicerna’s strategic objectives are met.
    • Cultivate effective working relationships with partners.
    • Assist in business development activities as required to support existing partnerships and future partnering efforts.
    • Proactively monitor partnerships and identify potential issues and timely solutions; gain alignment and take accountability for closure.
    • Manage dispute resolution through collaboration with internal and external decision makers.
    • Manage collaborations consistent with the contract and governance structure to maximize value; facilitate governance meetings. 

    Qualifications

    • S./M.S. in a scientific discipline. PhD or MBA preferred
    • Minimum of 10 years of experience in an alliance management role, working with development stage programs
    • Ability to multi-task and prioritize workload
    • Strong business acumen and understanding of drug development
    • Strong client service focus to build and sustain effective partnerships with key stakeholders and project teams
    • Exceptional interpersonal, and oral and written communication skills

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  • Scientist I / Scientist II, RNAi Pharmacology

    Posted October 1, 2018

     

    Dicerna is seeking a highly-motivated, experienced scientist to join our innovative team.  The ideal candidate will have a background in mouse modeling of human disease, and a strong foundation in molecular biology.  The candidate will be an integral part of our cross-functional R&D team and will generate important data that will enable development of new RNAi medicines.

     Key Responsibilities

    • Project leadership: perform innovative and challenging science to meet milestones
    • Pharmacodynamic and pharmacokinetic characterization of novel experimental RNAi therapeutics in rodents, and generation of molecular endpoint data
    • Development or implementation of rodent disease/phenotypic models to achieve therapeutic proof-of-concept
    • Collaboration with discovery biologists and medicinal chemists for platform development and lead optimization; interface with external partners
    • Pharmacology support for nonclinical and clinical-stage pipeline programs
    • Generation and communication of study reports, data packages, SOPs and related documentation

    Qualifications

    • Ph.D. + postdoc (or MS+10) in Biology, Pharmacology, Biochemistry, Pharmaceutical Sciences or equivalent
    • Expertise in rodent pharmacology including study design, dosing, necropsy, tissue processing; strong molecular biology and assay development/implementation skills (examples, but not all necessarily required: qPCR, NGS, FACS, Western/ELISA, IHC/histology).  Working knowledge of drug discovery processes, SAR and PK/PD concepts
    • Commitment to scientific rigor, high data quality and careful documentation
    • Demonstrated scientific track record
    • Ability to interact effectively on multidisciplinary teams and participate in our exciting, dynamic company culture
    • Ability to multitask, prioritize and manage timelines, manage projects and/or people.
    • Strong scientific writing skills, and experience in delivering effective scientific presentations to internal or external teams
    • Experience or working knowledge in nucleic acid therapeutics is a plus

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  • Research Associate/Associate Scientist, RNAi Pharmacology

    Posted October 2, 2018

     

    Dicerna is seeking a highly-motivated research scientist with in vivo experience to join our innovative team.  The candidate will perform in vivo experiments and generate bioassay data to advance our RNAi drug candidates and be an integral member of our R&D team.

    Key Responsibilities

    • Rodent handling, dosing, sampling and necropsy; planning and performing of all technical aspects of in vivo experiments
    • Contributing to a team tasked with evaluating novel experimental medicines in preclinical models of disease, and advancing our technology to enable development of the next generation of innovative RNA-based therapeutics
    • Performing laboratory assays according to SOPs, troubleshooting when needed
    • Maintaining careful laboratory notebooks and generating study reports

    Qualifications 

    • BS in Biology, Pharmacology, Biochemistry, Pharmaceutical Sciences or equivalent
    • 1+ years (Research Associate) or 3+ years (Associate Scientist) of experience, including in vivo, in a relevant academic or industrial setting
    • Experience in rodent pharmacology including dosing and tissue collection
    • Experience in standard laboratory methodologies; aseptic technique; working knowledge of molecular biology
    • Experience in common methods of data analysis, including scientific software
    • Commitment to careful and thorough technical documentation, including electronic laboratory notebooks and study reports
    • Ability to interact effectively on multidisciplinary teams and participate in our exciting, dynamic company culture; ability to work independently
    • Ability to multitask and prioritize

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  • Associate Director, Clinical Quality Assurance

    Posted October 18, 2018

     

    We are seeking an Associate Director, Clinical Quality Assurance to manage the ongoing Clinical QA activities to support GCP and Clinical Trial Obligations.  You will support clinical development and be empowered to develop clinical quality programs and systems as you represent Clinical QA.

     

    Responsibilities

    • Collaborate with Clinical Development and related functional areas to ensure clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Dicerna Policies and Procedures.
    • Interpret and provide key metrics to Clinical Development Team, Quality Team and cross-functional development team members.
    • Support GCP SOP development and serve as quality operations reviewer. Act as a strategic GCP quality resource providing GCP technical guidance recommendations to development teams.
    • Execute risk-based methodologies for the planning and execution of clinical protocols
    • Manage clinical quality issues including audit reports, quality issues/incidents, and CAPA development.  Ensure timely implementation and closure of CAPAs.
    • Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Ensure timely review and closure of quality issues.
    • Lead systems monitoring and process improvement initiatives that enhance regulatory compliance and CQA operating efficiency.
    • Assist with inspection readiness including SME training/preparation and back room activities during GCP inspections.  Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program.
    • Use knowledge of GCP, clinical development, and industry best practices to provide guidance, training and input to business partners on compliance issues. Able to adapt precedent and develop creative and effective solutions to solve problems.

    Qualifications

    • BSN or B.S. in related scientific field is required.
    • 8+ years of experience in the pharmaceutical or biotechnology industry with 5 years of GCP-related Quality Assurance experience.
    • In depth knowledge of the applicable global GCP regulations, Good Clinical Practices, ICH Guidelines.
    • Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and to data integrity.
    • Strong organizational and management skills to communicate to multi-disciplinary project teams.
    • Ability to present data and defend approaches to inspectors.
    • Ability to comprehend regulations and guidance documents and technical information related to equipment, processes, and regulatory expectations.
    • The ability to think strategically and maintain an attention to detail.
    • Capable of working independently with minimal supervision and interacting with staff in a fast-paced sometimes pressure filled environment.
    • Excellent written and verbal communication skills coupled with strong negotiation and decision-making skills.
    • Strong comprehension of while applying critical thinking skills to evaluate requirements.

     

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  • Medicinal Chemist

    Posted November 2, 2018

     

    We are seeking a highly skilled and motivated synthetic chemist able to function in a fast-paced, collaborative environment. The successful candidate will be a member of the chemistry team responsible for the synthesis of nucleoside analogues and oligonucleotide conjugates and will work closely with contract research/manufacturing organizations on the scale-up and tech transfer of processes.

     

    Responsibilities

    •Design, plan and execute multi-step organic synthesis and purification of high quality target molecules.

    •Review research papers and intellectual property literature and propose novel target molecules.

    •Operate and maintain multiple instrumentation including HPLC, LCMS for purification, characterization and purity determination of prepared compounds.

    •Assist in the planning and management of external research efforts for contract research organizations and collaborations.

    •Function as a senior member of the chemistry group aiding in the preparation of intellectual property, publications, and project planning.

    Qualifications

    •Ph.D. in organic chemistry with 1-7 years of relevant experience.

    •In-depth knowledge of organic chemistry reactions and mechanisms.

    •Experience with chromatography techniques i.e. LC-MS, ion exchange and RP-HPLC.

    •Thorough understanding of analytical techniques (HPLC, LC-MS) for characterization of nucleoside and oligonucleotide compounds.

    •Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.

    •Experience in heterocyclic and/or carbohydrate chemistry, familiarity with nucleoside synthesis, bio conjugate chemistry is preferred along with knowledge in oligonucleotide chemistry.

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  • Scientist/Associate Scientist/Research Associate – Oligonucleotide Synthesis

    Posted November 2, 2018

     

    Dicerna Pharmaceuticals is seeking highly motivated scientists to join its oligonucleotide/medicinal chemistry team in Cambridge, Massachusetts. The candidates will be responsible for the synthesis, deprotection, and purification of oligonucleotides, and the analysis and characterization of oligonucleotides. This position will support therapeutic programs in multiple disease areas and will contribute to the development of novel nucleic acid conjugate platforms. Prior experience in oligonucleotide synthesis and characterization is desired but not required.

     

    Key Responsibilities:

    • Synthesis of oligonucleotides, deprotection, purification, annealing and lyophilization of oligonucleotides to support all disease programs
    • Analytical characterization of the synthesized oligonucleotides for purity determination and impurity profiling
    • Support new chemistry discovery for the development of novel oligonucleotide conjugate platforms
    • Operate, maintain, and troubleshoot lab instruments such as oligonucleotide synthesizers, purification systems, HPLC and LC-MS
    • Conduct laboratory work in safe, efficient manner that ensures a safe working environment for colleagues
    • Ability to complete assignments and meet deadlines and time schedules
    • Keep accurate record of the experiments and summarize the results in written reports
    • Possess excellent written and verbal communication skills
    • Demonstrate an ability to work as part of a team and possess an excellent work ethic
    • Ability to be successful in a fast-paced, intense work environment

    Qualifications:

    • PhD in Chemistry or related field with 1-2 years of industrial experience, or MS with at least 3 years of industrial experience, or BS with 5 Years
    • Strong knowledge of nucleic acids chemistry, oligonucleotide synthesis, deprotection and purification techniques
    • Experience with oligonucleotide synthesizers preferred
    • Experience with analytical techniques e.g. RP-UPLC, SAX-HPLC, LC-MS and data interpretation

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