5 дней назад
Senior DMPK Director
183 000 - 260 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior DMPK Director (ADME/Pharmacokinetics): Developing and implementing DMPK and modeling & simulation strategies to advance drug candidates from discovery through development, with an accent on translational ADME, pharmacokinetic and pharmacodynamic analysis, and regulatory submissions. Focus on establishing in vitro to in vivo correlations, characterizing drug-drug interactions and biopharmaceutics liabilities, and building comprehensive IND/NDA-enabling DMPK packages.
Location: Alameda, California, United States; office-based
Salary: $183,000–$260,000 annually, plus bonus eligibility and equity incentives.
Company
is a biopharmaceutical company developing drug candidates and advancing them through clinical development and regulatory registration.
What you will do
- Lead translational IND- and NDA-enabling ADME work and characterize the ADME properties of drug candidates.
- Develop DMPK and modeling and simulation strategies across discovery and development programs.
- Analyze preclinical pharmacokinetic and pharmacodynamic data to support drug development decisions.
- Partner with Discovery, Clinical Pharmacology, Pharmacometrics, Translational Medicine, CMC, Toxicology, Clinical Development, and Regulatory functions.
- Prepare DMPK content for IND, CTA, and NDA filings, study protocols, study reports, and investigator brochures.
- Present scientific findings to senior management, project teams, and internal and external collaborators while maintaining external scientific visibility through publications.
Requirements
- PhD in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or a related field.
- At least 12 years of DMPK experience and a minimum of 14 years of relevant pharmaceutical-industry experience.
- Expert knowledge of in vitro and in vivo ADME studies, drug metabolism, transporters, enzymology, enzyme kinetics, and in vitro to in vivo extrapolation.
- Experience managing external DMPK work at CROs and identifying clinical candidates by balancing ADME, pharmacology, and toxicology properties.
- Experience with physiologically based and empirical modeling and simulation techniques, including drug-drug interactions and biopharmaceutics liabilities.
- Experience submitting IND, NDA, BLA, and global marketing applications, with strong scientific leadership and cross-functional collaboration skills.
Nice to have
- Experience with antibody-drug conjugates.
Culture & Benefits
- Collaborative, modern open-plan office with dual monitors and ergonomic workstations.
- Health, dental, and vision coverage, life and disability insurance, flexible spending accounts, and a 401(k) plan with company contributions.
- Discretionary annual bonus program and opportunities to purchase company stock and receive long-term incentives.
- 15 accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days annually.
- Science-driven environment focused on innovation, teamwork, agility, transparency, accountability, and empowerment.
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