2 дня назад
Director, Nonclinical DMPK
186 489 - 278 875$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Nonclinical DMPK (Pharmaceutical Drug Development): Leading the design, execution, and evaluation of nonclinical DMPK programs for small molecules across discovery and development portfolios with an accent on scientific strategy, risk assessment, and regulatory readiness. Focus on interpreting DMPK data, guiding asset progression, managing outsourced studies, and preparing IND- and NDA-related regulatory documents.
Location: Princeton, NJ, United States
Salary: $186,489–$278,875 per year, plus incentive opportunity.
Company
is a pharmaceutical company developing and advancing medicines through discovery, clinical development, and regulatory submission.
What you will do
- Lead strategic and technical Nonclinical DMPK activities across multiple small-molecule discovery and development programs.
- Serve as the DMPK functional expert on cross-functional teams and provide risk-based recommendations for program progression.
- Review and integrate DMPK data into nonclinical assessments, development strategies, portfolio decisions, and regulatory objectives.
- Oversee outsourced studies, timelines, budgets, deliverables, and study execution.
- Author and review regulatory documents, including INDs, NDAs, aggregate reports, fast track designation materials, 8-FA, ICFs, and briefing books.
- Establish scientific standards, technical guidance, best practices, and continuous improvement initiatives for the Nonclinical DMPK function.
Requirements
- MSc or PhD in Chemistry, Biology, Pharmaceutical Sciences, or a related field.
- At least 7 years of experience in a pharmaceutical company or contract research organization.
- Experience delivering discovery and early-development assets to the clinic and proof of concept.
- Strong technical experience planning and executing nonclinical studies, with thorough knowledge of regulatory requirements and drug development.
- Ability to prioritize changing business needs and manage multiple programs simultaneously.
- Strong written and verbal communication skills, attention to detail, and experience working in cross-functional project teams.
Nice to have
- Regulatory expertise, including successful IND or CTA submissions.
- Experience analyzing competitive scientific knowledge from external sources.
Culture & Benefits
- Comprehensive medical, dental, vision, and prescription drug coverage.
- Company-provided life, accidental death and dismemberment, short-term disability, and long-term disability insurance.
- Tuition reimbursement and student loan assistance.
- Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
- Collaboration, accountability, strategic thinking, patient centricity, and professional development are emphasized.
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