Director, Nonclinical DMPK
About The Position
The Director, Nonclinical DMPK is responsible for strategic, technical and scientific matters related to the design, execution and evaluation of Nonclinical DMPK programs for small molecules. The role provides strategic leadership for Nonclinical DMPK activities across multiple discovery and development programs and serves as a recognized scientific expert within the organization. The position influences portfolio decisions, establishes scientific standards and best practices, and provides strategic DMPK guidance to cross-functional teams and senior leadership to support program advancement and regulatory objectives. This includes the preparation of regulatory documents such as INDs, NDAs, aggregate reports, fast track designation, 8-FA, ICFs, and briefing books.
Requirements
- MSc or PhD in Chemistry, Biology, Pharmaceutical Sciences, or related area with at least 7 years of experience in a pharmaceutical company or contract research organization
- Proven track record in delivering discovery and early development assets to the clinic and POC
- Strong technical experience in planning and executing nonclinical studies
- Thorough knowledge of regulatory requirements and the overall drug development process
- Ability to assess and prioritize tasks as business needs change and manage multiple programs simultaneously
- Detail-oriented with strong written and verbal communication skills, and demonstrated ability to work in cross-functional project teams
Nice To Haves
- Regulatory expertise preferred, including successful IND/CTA submissions
Responsibilities
- Serve as the DMPK functional expert on cross-functional discovery and development teams and provide strategic nonclinical safety recommendations to support program progression and development decision-making
- Communicate DMPK findings and risk assessments to project teams and senior leadership, influencing program decisions through scientifically sound and risk-based recommendations
- Provides strategic oversight of DMPK activities across multiple discovery and development programs, including IND- and NDA-enabling studies, ensuring consistency of scientific approaches and alignment with organizational objectives
- Influence portfolio decisions through integrated interpretation of DMPK data, risk assessments, and strategic recommendations regarding asset progression and development plans
- Review, analyze and interpret scientific data and results for DMPK studies and integrate findings into overall nonclinical assessments and development strategies
- Manage outsourcing and study activities, study timelines, budgets, and deliverables for assigned programs
- Act as author/co-author and reviewer of regulatory documents
- Collaborate within the nonclinical team to incorporate new guidance requirements
- Analyze competitive scientific knowledge from external sources
- Establish and maintain scientific standards, best practices, and technical guidance across the Nonclinical DMPK function
- Contribute to continuous improvement initiatives, scientific standards, and implementation of evolving regulatory guidance for Nonclinical drug assessments
Benefits
- Comprehensive medical, dental, vision, prescription drug coverage
- company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
- tuition reimbursement
- student loan assistance
- a generous 401(k) match
- flexible time off
- paid holidays
- paid leave programs
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What This Job Offers
Job Type
Full-time
Career Level
Director
