Sr./Director, Regulatory Strategy, Oncology
Moderna Therapeutics is seeking a Sr. Director/Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as a novel drug modality. The Sr. Director/Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology.
Here’s What You’ll Do:
- Sets strategic direction and leads the development of content, format and accountability for regulatory submissions and related supplements and amendments.
- Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes. Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
- Establishes and maintains excellent relationships with global health agencies.
- Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly and effectively with health agencies regarding company’s filings.
- Reviews and approves technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
- Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
- Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Develops and maintains the Target Label Profile and the Company Core Data Sheet.
- Reviews all external materials for regulatory compliance.
- Collaborates with internal teams and Moderna partners to achieve project goals, including development content and management submissions to Health Agencies.
- Serves as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project.
- Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate
- May be responsible for line management and development of direct reports
- Identify areas in need of improvement and lead the development and implementation of process improvements
- Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables
Here’s What You’ll Bring to the Table:
- BA/BS degree in a scientific/engineering discipline
- 12+ years of experience in the Pharmaceutical industry
- 8+ years of experience in Regulatory strategy, including specifically: rare diseases
- Strong knowledge of current US and EU regulations, including specifically: e.g. novel regulatory pathways.
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Experience with developing and implementing competitive regulatory strategies
- Demonstrated track record in securing product approvals and maintaining a complex portfolio
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Demonstrated competence in employee management and development
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU
- Direct experience of leading regulatory authority meetings in different phases of drug development
- Regulatory knowledge across therapeutic areas including rare diseases is preferable.
- Preferred: Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification
- Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)
Here’s What We’ll Bring to the Table:
- On-site subsidized cafeteria or catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Free annual corporate membership to Bluebikes
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Learn more here
Job posted: 2020-05-21