Associate Director Clinical Pharmacology

Regeneron Pharmaceuticals • Warren, MI

4d • Onsite

About The Position

As an Associate Director Clinical Pharmacology, this individual is expected to proactively identify and provide significant Pharmacometrics (PMx) contributions, potentially of a complex nature, for research and development programs. They are expected to address strategically important program needs that represent scientific advancements of one or more programs and/or aptly address significant regulatory hurdles. This role is regarded as an expert in the field; as such, the individual is able to contribute to the overall strategic program development and is able to communicate complex PMx strategies and results in an influential manner to the development team. They are also expected to independently design, conduct, and oversee the development of PMx analysis plans and apply standardized or advanced scientific techniques to conduct PK, PD, and/or other types of quantitative analyses.

Requirements

• A PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree and at least 6 years of relevant Clinical Pharmacology experience.
• Understanding of PMx concepts and techniques, such as advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods, compartmental modeling, translational modelling/pharmacology, Exposure-Responses analysis methods, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP.
• Knowledge of innovative PMx methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, and strategies for handling missing data.
• Good regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory review and approval of BLA or equivalent.
• Ability to formulate PMx objectives, design, and analyses for complex clinical projects.
• Proficient in use of MS-Excel, R, R-Studio, Phoenix WinNonlin, NLME, NonMem, STAN, working in department computing environment.

Responsibilities

• As a PMx Program Representative on program teams, effectively communicate complex PMx results in colloquial terms understandable to the development teams with the ability to be influential with the development team.
• Independently plans and conducts or otherwise oversees the development of PMx analysis plans and applies standardized or advanced scientific techniques to conduct PK, PD, and/or other types of quantitative analyses and has final responsibility for ensuring the accuracy of analyses.
• Independently authors PMx contributions to regulatory documentation, including those for pre-IND, EOP2, and pre-BLA meetings.
• Performs additional analyses as required to support regulatory interactions.
• Independently drafts and reviews documentation for accuracy, clarity, and messaging to ensure documents are appropriate for further PMx management review.
• With limited guidance from senior departmental staff, works directly with development or Research teams on PMx elements of program strategy and the PMx aspects of study design and results at management forums (RPR, DPR, and PRC).
• Contributes to the development of accurate tables and figures for inclusion in slides for senior management presentations.
• In conjunction with PMx management, is responsible for contributing to the drafting of PMx program strategies to support one or more standard programs.
• Provides leadership support to a study team on all relevant PMx deliverables and objectives and independently leads a project.
• Represents PMx at routine pre-IND, Type C, pre-BLA, and other HA meetings.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree