Posted: 7 March 2023
The Role:
The candidate must thrive in a fast paced, dynamic environment with high expectations. Multitasking, doing things in parallel and being bold to push the boundaries of science will are key values to thrive in our Team. Strong understanding of technical aspects and standard methodologies in Clinical Pharmacology and Pharmacometrics, experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical data. Experience leading clinical pharmacology aspects of programs at all stages of development and experience with writing and defending the clinical pharmacology sections of an NDA/BLA is strongly preferred.
Here’s What You Will Do
- Development and execution of the Clinical Pharmacology strategy on assigned program(s) and represent clinical pharmacology function on project teams through all stages spanning from early development (pre-IND) through late stage-development (Phase 3, filings worldwide, and lifecycle management)
- Responsible for clinical pharmacology summary documents (such as IB, BB, CTA, CTD Module 2 documents, product labeling, etc.).
- Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., Pharmacometrics, QSP and DMPK). Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans to enable Model-Informed Drug Development (MIDD).
- Works closely with colleagues in QS to ensure strategic integration of advanced modeling and simulation approaches (e.g., QSP, MBMA) across the development continuum to inform internal decisions and external regulatory interactions.
- Mentors junior staff as needed
Here’s What You’ll Bring to the Table
- PharmD/Ph.D. with 9+ years of proven experience in clinical pharmacology in biotech and/or pharmaceutical industry.
- Experience leading clinical pharmacology aspects of programs at all stages of development.
- Experience with writing and defending the clinical pharmacology sections of an NDA/BLA is strongly preferred.
- Experience in FIH dose determination, dosing schedule and clinical trial design.
- Writing and contributing to the product label.
- Regulatory considerations in execution of clinical PK (PK/PD) studies in different patient populations.
- Experience in participation on regulatory agency meetings.
- Strong data analysis skills and an in-depth knowledge of population pharmacokinetic and pharmacodynamic principles, including their interpretation and integration with safety and efficacy data to ensure appropriate dosing regimen decisions are made.
- Understanding of clinical biomarkers and pharmacogenomics applications to clinical trial design and patient outcomes.
- Understand the ethical aspects of clinical trial research.
- Comprehensive understanding of clinical regulatory requirements and knowledgeable in ICH and GCP guidelines.
- Ability to produce and present quality scientific presentations at internal or external meetings.
- Excellent verbal and written communication and presentation skills.
- Demonstrated ability to work effectively in a matrix, team environment, manage multiple priorities and exercise sound judgment.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- Discretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
