Jobs · Analyst · Massachusetts

Associate Director, Clinical Pharmacology

BioNTech SE · Cambridge, MA · 2 wk ago
Analyst$146k–$234k/yrFull-time

Cambridge, US; Gaithersburg, US; New Jersey, US | Full time

About the Role

At BioNTech, we are committed to revolutionizing medicine through cutting-edge science and innovation. As Associate Director, Clinical Pharmacology & Pharmacometrics, you will play a pivotal role in advancing our drug development pipeline. With limited supervision, you will lead the design and execution of clinical pharmacology studies, provide scientific expertise in pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics (PMx), and contribute to regulatory submissions such as INDs and NDA/BLAs. Collaborating with multidisciplinary teams, you’ll drive strategies that shape the future of transformative therapies for oncology, infectious diseases, and beyond. This is an opportunity to make a meaningful impact on patient lives while mentoring the next generation of scientists in a dynamic and innovative environment.

Responsibilities

  • Lead the analysis, interpretation, and reporting of clinical pharmacokinetic data
  • Drive PKPD modeling, exposure-response analyses, and translational quantitative pharmacology activities to support optimal dose and dose selection decisions
  • Plan, design, execute, and report clinical pharmacology studies (e.g., QT assessments, food effect studies, ADME investigations, DDI strategies) to support drug development and rapid product registration by working with cross-functional teams
  • Collaborate with research leads on study design and data interpretation of PK, toxicokinetic and PD aspects of preclinical studies
  • Provide clinical pharmacology and pharmacometrics input into regulatory documents (e.g., IBs, briefing books, NDA/BLA submissions)
  • Represent BioNTech at global health authority meetings, providing clinical pharmacology and pharmacometrics expertise

Requirements

  • Advanced scientific training (Ph.D., MD, or Pharm.D.) in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics or related discipline
  • Minimum 5 years of experience in clinical pharmacology within the biotechnology or pharmaceutical industry
  • Proven track record leading drug development programs from early exploratory studies through Phase 2/3 trials
  • Expertise in translational research or pharmacometrics applied to oncology or infectious disease drug development
  • Proficiency with modeling software such as Phoenix WinNonlin, R, NONMEM, MATLAB
  • Strong communication and presentation skills with ability to lead cross-functional teams in a matrix environment
  • Self-motivated with a collaborative mindset and commitment to innovation

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

Pay

Expected Pay Range: $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).

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