Principal Scientist, Pharmacometrics Jobs

The Role:
The Principal Scientist of Pharmacometrics is a scientific position responsible for delivering disruptive advancements at delivering model informed drug development (MIDD) for accelerated clinical development of mRNA vaccines and therapeutics. The individual will closely collaborate with cross-functional multidisciplinary teams and develop pharmacometrics 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.
Here’s What You’ll Do:

• Actively contribute to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
• Strengthen our pharmacometric capabilities on a continuous basis by evaluating and incorporating new M&S tools and initiating trainings as appropriate
• Oversee, lead and review pharmacometrics model development efforts across development programs 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
• Provide leadership in maintaining scientific awareness and presence in quantitative pharmacology and pharmacometric science, preparation of abstracts and manuscripts for publication
• Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy

Here’s What You’ll Bring to the Table:

• Strong publication record in pharmacometrics
• PhD with a focus in pharmacokinetics, pharmacology, pharmaceutics or other related field with 6+ years of drug development experience
• Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams
• Demonstrated expertise in establishing and managing scientific and operational infrastructure for CPPM driving data-driven decision making across all phases of drug development
• Demonstrated expertise in innovating and applying population PK/PD and categorical data modeling techniques enabling MIDD
• Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.
• 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
• Deep understanding of pharmacometric principles and incorporation of M&S strategies in overall development plans
• 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
• Deep and broad experience in clinical and non-clinical drug development with in-depth expertise in quantitative clinical pharmacology and translational medicine
• 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

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Discretionary winter shut down
• Vacation, sick time and holidays
• Highly competitive and inclusive medical, dental and vision coverage options
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• 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
• Dedicated care coordination support for our LGBTQ+ community
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Generous paid time off, including:
• Volunteer time to participate within your community
• Exclusive preferred pricing on Peloton fitness equipment
• Free premium access to fitness, nutrition, and mindfulness classes
• Free parking or subsidized commuter passes
• Adoption and family-planning benefits
• 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.
About Moderna
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 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.
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