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 HR@dicerna.com.

 

Career Opportunities

  • Assoc. Director/Director of Manufacturing

    Posted June 7, 2017

     

    Overview

    The Assoc. Director/Director of Manufacturing is responsible for leading and coordinating manufacturing operations at CMOs. The incumbent is responsible for ensuring that current GMP standards, are implemented for the production and the control of Third Party manufactured drug substance and/or drug products.

    Key Responsibilities

    • Manage day to day activities at drug substance and/or drug product contract manufacturing organization (CMOs). Has direct interaction with contract site management (may include being on site at CMO).
    • Proactively manages risks/capability and develops mitigation plans. Identifies and communicates risks and issues that impact quality, compliance, project timelines, resource requirements, finances or the overall business relationship.
    • Review and approve, as required, CMO documentation, including:
      • Analytical, process development and stability protocols, methods and reports
      • Technical review of CMO change documentation
      • Technical review of draft and executed batch records
      • Monitor drug substance and drug product stability programs
      • Write and review CMC sections of regulatory documentation (e.g. pre- IND, scientific advice meetings, IND/IMPD)
    • Participation in audits of current and potential CMOs as technical representative
    • 10% Travel

    Qualifications

    • Proven experience in management of GMP manufacturing activities
    • Prior CMC/manufacturing responsibilities in innovator company and the management of Contract Manufacturing Organizations required
    • Oligonucleotide experience highly desirable
    • Demonstrated project management skills and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
    • Experience writing and reviewing CMC sections of INDs/IMPDs
    • BS or MS degree in Chemistry/Chemical Engineering + 8-10 years of related experience in the biotechnology/pharmaceutical industry.

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  • Head, Clinical Operations

    Posted June 28, 2017

     

    Overview

     

    In this critical role, you will be responsible for leading and building a team of Clinical Operations professionals who will oversee the strategy for implementation and the execution of all Dicerna sponsored clinical trials. This involves ensuring that Dicerna’s clinical stage programs achieve program objectives within established timelines, budget and quality standards. Working with functional leadership at Dicerna, the individual will ensure that the appropriate company infrastructure and quality systems are in place to support all clinical trials.  The Head of Clinical Operations is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

    Key Responsibilities

    • Provides strategic and technical guidance to ensure that clinical trials are properly defined, planned and executed. Leads and directs the clinical operations team responsible for management and execution of all clinical trials. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met.
    • Working in a matrix organization, ensures that study objectives are in line with the clinical development strategy and the overall corporate goals.
    • Leads and directs the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
    • Ensures that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation.
    • Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
    • Builds collaborative relationships with key internal stakeholders including Clinical, Product Development, Regulatory Affairs, IT, Legal, Finance departments, and project teams as needed to support clinical programs.
    • Collaborate with KOLs for feedback on study protocols and development plans.
    • Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
    • Contributes to business development activities. This includes providing critical due diligence and analysis of programs.

    Qualifications

    • 10+ years of strong hands-on experience leading clinical trials execution, preferably in rare or pediatric diseases both in the USA and Europe.
    • Thorough working knowledge across a broad range of drug development areas.
    • Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
    • In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
    • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
    • Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
    • Excellent verbal and written communication skills.
    • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
    • Flexibility to travel domestically and internationally as required.

    Special Knowledge Preferred

    • Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
    • Experience setting up clinical trials outside of US and Europe.
    • Field monitoring and/or clinical data management experience.
    • Medical writing experience.
    • Proficiency with Microsoft Project.

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  • Head, Quality Assurance

    Posted June 29, 2017

     

    Overview

     

    We are seeking a head of quality assurance who will develop and execute quality strategy and goals in line with the overall plan for the Company. This role requires a strategic thinker to work collaboratively across the Dicerna organization to build a quality system and processes to support all company operations. This individual will manage all aspects of quality across the GCP, GMP, GLP and quality systems functions.   This role will have significant interface with both internal teams as well as a network of external consultants/vendors.

    Key Responsibilities

     

    • Establish quality programs, policies and procedures to ensure compliance with GxP standards, FDA, ICH and other regulatory guidelines.
    • Create /revise controlled documents and ensure that the organization is trained to standards of quality excellence.
    • Represent Quality function on development project teams.
    • Review and approve documents necessary to support the program and disposition activities originating from internal departments and vendors (e.g. batch records, investigations, CAPA).
    • Responsible for the qualification program for GLP and GMP vendors. Monitor and develop metrics to review performance of vendors & CMOs.
    • Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues.
    • Identify procedural and process issues and oversee implementation of necessary corrective actions and continuous improvement activities.
    • Lead efforts and collaborate with internal and external partners to ensure readiness of all GCP, GLP and GMP activities associated with regulatory filings, this includes assisting in site preparations for support of regulatory inspections.
    • Work closely with both the early development and clinical groups at Dicerna. Interpret regulations and apply as appropriate to the phase of product development.
    • Assure necessary QA review of regulatory submissions of INDs, NDAs etc. as assigned.
    • Review of Quality System Metrics with Senior Management Team on a regular basis.
    • Provide quality expertise, advice and/or assistance across the organization as required

     

    Qualifications & Capabilities

     

    • Bachelor’s degree in a scientific or life science field
    • Minimum of 10+ years of quality experience in the biotechnology or pharmaceutical industry
    • Strong knowledge of cGxPs in the U.S. and internationally, with emphasis primarily on GMPs
    • Experience with all phases of product development
    • Knowledge of cGMP and ICH regulations, practices and trends pertaining to pharmaceutical product development, and manufacturing.
    • Experience auditing and building relationships with external vendors
    • Demonstrated leadership and project management skills

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  • Toxicologist

    Posted August 11, 2017

     

    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 2-5 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

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  • Medical Writer

    Posted August 11, 2017

     

    Reports to:                 Chief Medical Officer

    Overview

    The medical writer will be a key member of the Project Team and will work closely with Research, Clinical Operations and Regulatory Affairs to manage all aspects of document preparation for clinical and regulatory documents according to company guidelines and international governmental regulations. S/he 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 non-clinical, clinical and regulatory documents. Documents will include, but are not limited to: IND, CTA, non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, annual reports/development safety update reports (DSURs) etc.
    • Assist in developing strategy for organizing and preparing documents for regulatory health authority submissions.
    • Coordinate the internal review of documents.
    • Develop, maintain, and drive document finalization timelines.
    • Ensure final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the International Council on Harmonisation (ICH).
    • Perform quality control review of medical writing documents
    • Assist in the development of templates, style guidelines, and SOPs for clinical documentation

    Requirements

    • Minimum requirement of a bachelor’s degree with 3-5 years of medical writing experience in a pharmaceutical/biotechnology or CRO environment
    • Ability to interpret and present clinical and 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; experience using electronic document management system

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