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

  • Toxicologist

    Posted July 11, 2018

     

    We are seeking a Toxicologist 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)

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  • 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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  • 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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  • Supply Chain Manager

    Posted July 6, 2018

     

    Location: Boulder, CO

     

    We are seeking an experienced supply chain manager to join our manufacturing operations team.  The candidate will be responsible for developing and managing Dicerna’s supply of drug product through all stages of clinical development and commercial launch.

    Key Responsibilities

    • Responsible for all day-to-day activities related to managing the supply of starting materials, API, clinical and commercial drug product.
    • Coordinate and track domestic and international shipments across the supply chain.
    • Own clinical supply activities including planning, labeling, packaging and distribution of medicinal product for multiple programs.
    • Develop and implement overall supply plans based on CMC and clinical development plans.
    • Forecast supply needs in conjunction with clinical, program development and manufacturing.
    • Manage and monitor forecast activities related to drug substance, drug product and clinical supplies at the program and study level.
    • Negotiate and communicate supply plan timelines to internal and external partners.
    • Negotiate clinical and commercial supply agreements.
    • Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are implemented.
    • Work with finance and VP manufacturing to create clinical supply study budgets.
    • Work with internal regulatory, clinical, quality and CMC teams to ensure execution of all supply chain activities.

    Qualifications

    • BS degree in life sciences, chemistry or equivalent with 8+ years as a supply chain leader in the biopharmaceutical industry
    • Working knowledge of regulations related to clinical labeling, packaging and distribution activities globally (cGMP, GCP, ICH)
    • Strong project management skills
    • Experience managing relationships with CMOs/CROs

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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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  • Associate Scientist, RNAi Pharmacology

    Posted July 19, 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 dosing, sampling and necropsy; planning and performing of all technical aspects of in vivo experiments
    • Generating and analyzing molecular assay data
    • Maintaining careful laboratory notebooks and generating study reports; presenting data at group meetings and company-wide meetings

     

    Qualifications

    •  BS/MS in Biology, Pharmacology, Biochemistry, Pharmaceutical Sciences or equivalent
    • Experience in rodent pharmacology including dosing and necropsy
    • Experience in downstream bioassays including one or more of the following:  qPCR, ELISA, FACS, Western Blot
    • 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 multitask and prioritize

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  • Manager/Sr. Manager of GXP Auditing and Compliance

    Posted July 24, 2018

     

    Overview

    Dicerna is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare diseases, chronic liver diseases, cardiovascular disease, and viral liver infectious diseases.  The Company is using its proprietary GalXC™ RNAi technology platform to build a broad pipeline in these therapeutic areas.

     

    The Sr. Manager of Auditing and Compliance will:

    • Develop risk-based audit schedules
    • Schedule and conduct internal and external auditing
    • Review and tracking audit reports, responses and CAPAs generated
    • Maintain GXP databases and audit files
    • Participate in GXP internal and external audits
    • Support regulatory inspection activities
    • Identify and escalating critical findings to management
    • Manage vendor management activities (e.g., Quality Agreements, Periodic Review, Approved Vendor List Maintenance)
    • Provide updates on key quality system metrics
    • Support site QA organizations during regulatory inspections
    • Support continuous improvement activities
    • Present key issues related to product quality to Quality Management
    • Be a self-starting problem solver who drives results through high compliance and a positive work style.

     

    Key Responsibilities and Major Duties


    The Sr. Quality Assurance Manager / Quality Assurance Associate Director is responsible for managing assigned projects from inception to successful completion, making coordinated use of processes and systems to guide and encourage assigned personnel to successfully perform assigned tasks. Additional responsibility for execution and maintenance (data entry, reporting, filing, archival) of assigned quality system.  Acts as technical resource for Quality. The duties listed below are illustrations of the various type of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to this class.

    • Provide management oversight of activities associated with an independent GxP audit program for internal and external systems across the end-to-end product lifecycle including strategy, planning, execution, reporting and observation follow-up. Includes internal and external (vendor and/or contract service provider) audits.
    • Recruit and train staff to carry out all functions of the GxP-QA Audit Operations and Strategy.
    • Review and/or approve appropriate policies and procedures in alignment with relevant governmental regulations and guidelines.
    • Lead the execution of audit plans and schedules based on informed risk and in collaboration with other GxP audit functions.
    • Utilize a risk-based approach in the development of audit scope with focus on critical controls impacting patient safety, product quality and data integrity
    • Both peer review and/or prepare clear, concise, accurate and evidence-based audit reports to effectively communicate audit findings and recommended corrective action to management. Discern significant audit issues and identify appropriate recommendations. Review and assess corrective and preventive action plans according to specified timelines to assure resolution of audit findings and prevent re-occurrence. Maintain detailed documentation supporting the audit
    • Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned
    • Manage alignment and allocation of resources to ensure adequate and timely regulatory compliance support.
    • Participates as QA representative on relevant operations team.
    • Ensuring implementation and documentation of the appropriate corrective action to resolve any problems or issues.
    • Reviewing the appropriate documents for completeness, prior to being archived.
    • Monitoring and authoring Quality Assurance standard operating procedures (SOPs) as required.
    • Evaluating vendors to assure compliance to the required regulations and project needs.
    • Providing GxP training and advice to staff.
    • Assisting with coordinating and scheduling departmental activities, vendor audits, and in process/ critical phase audits.
    • Assisting with ensuring that all client audit reports are responded to and resolved in a timely manner.

      

    Qualifications

    To perform this job successfully, an individual must have the following educational degrees and/or experience:

    • BS/BA in science related field or equivalent experience with 15 + years of related Quality Assurance experience.
    • 7+ years of auditing experience in a Quality Assurance Director and leadership related function.
    • Knowledge of GLP, GMP, GCP, Part 11 regulations, FDA Guidances for Industry, EU regulations, and other standards.
    • Knowledge of regulatory requirements for computer system validation.
    • The ability to think strategically and maintain an attention to detail.
    • The ability to interpret and apply these regulations and requirements to daily work.
    • Strong problem solving/analytical skills.
    • The ability to understand and verify scientific text and data.
    • Knowledge of Microsoft Office® applications and spreadsheet programs such as Excel, Word, Power Point, and Microsoft Project.
    • 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.

     

    KNOWLEDGE AND SKILL REQUIREMENTS

    • Leadership
    • People Skills
    • Strong Customer Satisfaction Focus
    • Team-oriented
    • Communication
    • Results
    • Problem Solving
    • Mathematical Skills

    Upload Résumé (We prefer PDF format)

  • Manager/Sr. Manager, Quality Validation

    Posted July 24, 2018

     

    Overview

    Dicerna is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare diseases, chronic liver diseases, cardiovascular disease, and viral liver infectious diseases.  The Company is using its proprietary GalXC™ RNAi technology platform to build a broad pipeline in these therapeutic areas.

     

    The Sr. Manager of Auditing and Compliance will:

    • Provide Quality oversight and leadership for validation activities related to Dicerna products produced at 3rd party CMOs / CTLs
    • Manage and coordinate process monitoring and continuous improvement initiatives as related to validation master plans per GMP requirements, as required.
    • Participate in providing quality input for protocol generation, execution, and final package preparation for process, equipment, facility and method validation activities. Review and approve equipment/facilities/utilities requirements, qualification protocols and summary reports, as well as requirements traceability matrices for compliance to quality system requirements.
    • Development and implementation of SOPs/Guideline documents with systemic procedural improvements related to validation activities.
    • Interact with third party manufacturers remotely and/or on-site.
    • Review and approve change controls related to the implementation of process changes, method improvements and equipment upgrades
    • Identify roadblocks and barriers; develop resolutions and know when to communicate them; provide clear communication to team members to meet project expectations; analyze data; evaluate results; form conclusions; recommend equipment and/or process improvements.
    • Provide Quality oversight and leadership for Computer System validation activities
    • Manage QA review and approvals of investigations, qualifications, validations protocols and reports
    • Lead and represent QA Validation in multi-departmental meetings & project teams owned by QA Validation.
    • Support site QA organizations during regulatory inspections
    • Support continuous improvement activities
    • Present key issues related to product quality to Quality Management
    • Be a self-starting problem solver who drives results through high compliance and a positive work style.

     

    Key Responsibilities and Major Duties

    The Sr. Quality Assurance Manager / Associate Director’s main responsibility is to provide Quality oversight of facilities, equipment, processes, cleaning, and method validations in a cGMP environment performed for Dicerna at Contract Manufacturing Organizations/Contract Testing Labs. Internal Dicerna validation systems may include computer systems validation oversight. The position will review and approve validation documentation, batch records and change controls, as well as provide input for GMP validation activities against regulatory requirements. Additional responsibilities may include conducting internal/external audits and training. This position provides quality recommendations and guidance to project teams and manages other compliance duties as assigned.

    These may include:

    1. General – Contributes to defining and timely achievement of overall project goals. Provides compliant solutions to a variety of problems of moderate scope and complexity. Interacts constructively with employees; managers and cross-functional peers. May lead a project with a limited scope; but usually a contributor on broader projects. Provides guidance to other Professionals and Technicians.
    2. Risk Management – Applies basic Risk Management principles to work. Participates in the development or modification of Risk management files.
    3. Design Control / Documentation & Change Control – Identifies areas for process improvement. Provides supporting information for change including reasons and justifications.
    4. Quality Engineering – Coordinates quality decisions between different quality and engineering groups. Participates in the development or modification of validation packages; design plans; and risk management deliverables (e.g. FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements

     

    Qualifications

    To perform this job successfully, an individual must have the following educational degrees and/or experience:

    • Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
    • 7+ years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in regulations related to process validation, process sciences and change control.
    • Organizational and management skills to communicate to multi-discipline project groups.
    • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
    • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
    • Experience and participation in regulatory inspections presenting departmental functions in audits or regulatory inspections.
    • Knowledge of GLP, GMP, GCP, Part 11 regulations, FDA Guidances for Industry, EU regulations, and other standards.
    • Knowledge of regulatory requirements for computer system validation.
    • The ability to think strategically and maintain an attention to detail.
    • The ability to interpret and apply these regulations and requirements to daily work.
    • Strong problem solving/analytical skills.
    • Knowledge of Microsoft Office® applications and spreadsheet programs such as Excel, Word, Power Point, and Microsoft Project.
    • 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.

     

    KNOWLEDGE AND SKILL REQUIREMENTS

    • Leadership
    • People Skills
    • Strong Customer Satisfaction Focus
    • Team-oriented
    • Communication
    • Results
    • Problem Solving
    • Mathematical Skills

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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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