Associate Director, Pharmacometrics

Role Summary

The Associate Scientific Director of Pharmacometrics is responsible for transforming non-clinical and clinical data into analyses that build the basis for model informed drug development (MIDD) 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 MIDD goals and to support the design, execution, and analysis of data emerging from clinical studies, will publish manuscripts and present at scientific conferences.

Responsibilities

• Apply state-of-art quantitative pharmacology and pharmacometrics methods within assigned programs to yield high value pharmacometrics support for critical decisions to advance development candidates
• Develop and execute modeling & simulation (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 pharmacometrics science, preparation of abstracts and manuscripts for publication
• Strengthen our pharmacometrics 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

Qualifications

• Required: PhD with a focus in pharmacokinetics, pharmacology, pharmaceutics or other related field with minimum of 8+ years of drug development experience post PhD
• Required: Hands-on proficiency in using pharmacometrics tools including but not limited to NONMEM, R, Julia, Monolix and Phoenix
• Required: Deep understanding of pharmacometrics principles and incorporation of M&S strategies
• Preferred: Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus.
• Preferred: Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.
• Preferred: Familiar in binary and categorical data analysis, 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 would be advantageous
• Preferred: Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis
• Preferred: Ability to develop and deliver clear and concise presentations for both internal and external meetings
• Preferred: Curious in exploring new paths for model informed drug development. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes
• Preferred: Strong publication record in pharmacometrics
• Preferred: Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams
• Preferred: Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.
• Preferred: A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.