The Associate Scientific Director of Pharmacometrics is responsible for transforming non-clinical and clinical data into analyses that build the basis for model informed development of innovative drugs accessible to patients. The Associate Scientific Director will collaborate with cross-functional multidisciplinary teams and develop models to quantify and predict exposure-response relationships to inform optimal decision making on key development questions such as dose selection and trial design. The ideal candidate will work independently to make decisions impacting M&S goals and to support the design, execution, and analysis of data emerging from clinical studies, will publish manuscripts and present at scientific conferences
Here’s What You’ll Do:
Apply state-of-the art quantitative clinical pharmacology and pharmacometric methods within assigned programs to yield high value pharmacometric support for critical decisions to advance development candidates
Develop and execute M&S plans to support candidate drug development
Independently develop and report population PK and PK/PD and disease progression analyses
Proactively incorporate and develop approaches and methodologies based on review of relevant scientific literature
Perform meta-analysis using proprietary and/or literature data
Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
Author M&S sections for regulatory interactions and responses
Participate 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
Actively contribute to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Here’s What You’ll Bring to the Table:
PhD or PharmD with a focus in pharmacokinetics, pharmacology, pharmaceutics or other related field with 5-10 years of drug development experience
Hands-on proficiency in using pharmacometrics tools including but not limited to NONMEM, R, Julia, Monolix and Phoenix
Deep understanding of pharmacometric principles and incorporation of M&S strategies
Expertise in binary and categorical data analyses, time-to-event (hazard) models, Poisson models, logistic regression, MCMC and Bayesian methods as applied to exposure-response analyses, meta-analyses and Population PK and PKPD analysis
Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis
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 pharmacometrics
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:
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 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.#LI-JW2