The Director of Clinical Pharmacology and Pharmacometrics (CPPM) is a leadership position responsible for delivering disruptive advancements to the CPPM science and operations aimed at delivering model informed drug development (MIDD) for accelerated translation of mRNA platform technology into mRNA medicines. The individual will supervise a team of pharmacometricians and clinical pharmacologists responsible for transforming non-clinical and clinical data into analyses that build the basis for model informed development for innovative drugs rapidly accessible to patients. The leader will closely collaborate with cross-functional multidisciplinary teams and develop pharmacometric strategies integrated with overall development plan to help data and model driven decision making on key development questions such as dose selection and trial design.
Heres What Youll Do:
Oversee, lead and review pharmacometric model development efforts across development programs in the autoimmune diseases therapeutic area (TA) for accelerated/optimized advancement of development candidates
Apply deep domain expertise to conceptualize MIDD approaches to provide model-based insights for development decisions in the early and late phases of development
Identify critical capabilities and resource needs to achieve functional needs. Oversee CRO selections, mentorships, operational activities, build external consultant networks and set the right balance of internal versus external capabilities
Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
Provide leadership in maintaining scientific awareness and presence in quantitative pharmacology and pharmacometric science, preparation of abstracts and manuscripts for publication
Strengthen our pharmacometric capabilities on a continuous basis by evaluating and incorporating new M&S tools and initiating trainings as appropriate
Demonstrate drive, visibility and influence in key company decisions including development candidate selection, patient dosage selection, clinical strategy, and regulatory filing strategy
Contributes to driving the shape of global regulatory filings including preparation of regulatory documentation and active participation in meetings with regulatory agencies
Actively contribute to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Heres What Youll Bring to the Table:
PhD with a focus in pharmacokinetics, pharmacology, pharmaceutics or other related field with 7-12 years of drug development experience
Deep and broad experience in clinical and non-clinical drug development with in-depth expertise in quantitative clinical pharmacology and translational medicine
Strong knowledge and experience in autoimmune diseases and/or immunology is highly desirable
Demonstrated expertise in establishing and managing scientific and operational infrastructure for CPPM driving data-driven decision making across all phases of drug development
Deep understanding of pharmacometric principles and incorporation of M&S strategies in overall development plans
Demonstrated expertise in innovating and applying population PK/PD and categorical data modeling techniques enabling MIDD
Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis
Must have the ability to communicate complex information succinctly
Must have excellent quantitative skills and a vision to leverage the science of dosage projection/simulation, drug-drug interactions, drug transporters, quantitative systems pharmacology, and pharmaceutics in a cutting-edge discipline
Ability to develop and deliver clear and concise presentations for both internal and external meetings
Candidate will be curious in exploring new paths for model informed drug development. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes
Strong publication record in CPPM
Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams
Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.
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 winter shut down
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.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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 persons 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.