Associate Director, Quantitative Clinical Pharmacology

BioNTech • Cambridge, MA

104d

About The Position

A genuine interest and understanding of the science supporting the pipeline, an ability to work collaboratively in a multidisciplinary team setting, and a commitment to developing new treatments for patients with cancer are critical for success.

Requirements

• Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or related discipline, or Pharm.D. or M.D. with relevant experience. M.S. with requisite experience will also be considered
• Minimum 5 years of experience in the biotechnology or pharmaceutical industry including a strong understanding of early and late drug development process from IND through NDA/BLA
• Direct experience in executing and leading modeling activities in drug development programs, from early exploratory studies to Phase 2/3 programs
• Strong fundamental understanding of PK and PK/PD data in the context of complex biology
• Preferred scientific and clinical background in Oncology
• Proficient in using Phoenix WinNonlin, R, NONMEM, MATLAB or other pharmacokinetic and modeling software
• Strong documentation and organizational skills

Responsibilities

• Leads the analysis, interpretation and reporting of clinical pharmacokinetic data
• Hands on population PK, ER and PK/PD modeling with corresponding experience with modeling and simulation software (ex. NONMEM, R)
• Drives the necessary PKPD, exposure response and translational modeling and quantitative pharmacology activities to achieve mechanistic understanding of novel drug candidates, and support optimal dose and dosing schedule decisions
• Partners with research leads for the design (analysis plans, project planning) and data analysis/interpretation of pharmacokinetic (PK), toxicokinetic and pharmacodynamics (PD) aspects of preclinical studies to deliver on-time support for key internal and regulatory interactions
• Provides quantitative clinical pharmacology input in regulatory documents (e.g. IB, regulatory briefing book, NDA/BLA)

Benefits

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree