A well-established, secure and commercially active biopharma is looking to bring on a Vice President, Quantitative Sciences & Development to lead Clinical Pharmacology, Pharmacometrics, Toxicology, DMPK, Biostatistics, Statistical Programming, and Clinical Data Management across all phases of drug development. This is a newly created role bringing these functions together under one integrated organization for the first time, spanning early development through regulatory submission.
The company has a marketed asset already generating commercial revenue in a specialty indication, alongside a growing, earlier-stage oncology pipeline, and is backed by a well-funded global parent.
Responsibilities
- Lead the company's Clinical Pharmacology, Pharmacometrics, Toxicology, DMPK, Biostatistics, Statistical Programming, and Clinical Data Management functions across all phases of development.
- Build and mentor high-performing teams across Clinical Pharmacology, Biometrics, and Data Management, recruiting and retaining top scientific and operational talent.
- Direct clinical pharmacology and toxicology strategy, including first-in-human, SAD/MAD, DDI, and population PK/PBPK modeling and dose optimization.
- Oversee biostatistical strategy across the portfolio, including study design, statistical analysis plans, adaptive designs, and integrated summaries.
- Provide executive oversight of statistical programming, including SDTM/ADaM development, CDISC implementation, and submission-ready datasets.
- Oversee clinical data management, including database design, data cleaning, medical coding, and enterprise data standards.
- Represent Clinical Pharmacology, Biometrics, and Data Management in regulatory interactions, including NDA/BLA submissions and FDA/EMA/PMDA meetings.
- Select and manage CROs and specialty vendors, establishing KPIs and overseeing budgets and contracts.
- Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, and Quality Assurance to advance the pipeline.
Experience Required
- PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Biostatistics, Pharmacokinetics, or a related scientific discipline.
- 15+ years of progressive pharmaceutical or biotechnology industry experience.
- Significant experience in Clinical Pharmacology and/or Biometrics leadership.
- Experience leading programs from early clinical development through regulatory approval, with demonstrated success supporting NDA/BLA submissions.
- Executive leadership experience managing global CROs and strategic partnerships.
- Experience in neuroscience, CNS, rare disease, oncology, or specialty pharmaceuticals preferred.
- East Coast based only.
Compensation DOE - base salary circa $350-400k 35% target bonus + benefits.