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Salary: USD 275,000 - 345,000 / annual
Frontier Medicines is seeking a VP of Clinical Pharmacology to lead clinical pharmacology strategy across its oncology clinical portfolio. This is a senior, cross-functional leadership role that spans nonclinical pharmacology (PK/PD/ADME and bioanalysis), clinical pharmacology (bioanalysis, dose selection, and PK/PD strategy) for active trials, DMPK oversight, and clinical pharmacology/biopharmaceutics input into CMC decisions.
You will serve as Frontier's senior-most clinical pharmacology leader, setting strategy and building out the function. You will partner closely with Clinical Development, Regulatory Affairs, Biometrics, and CMC, bringing hands-on scientific expertise to trial design, dose optimization, and regulatory strategy for oncology programs.
Key responsibilities include:
- Lead clinical pharmacology strategy across active clinical trials, including dose selection, dose escalation, dose optimization, and exposure-response analyses
- Oversee nonclinical and clinical bioanalytical strategies and execution
- Oversee DMPK activities in support of clinical and nonclinical program needs
- Provide clinical pharmacology and biopharmaceutics input into CMC decisions, including formulation strategy, bioavailability, and drug-drug interaction risk
- Lead development of clinical pharmacology content for regulatory submissions, including IND/CTA sections and briefing documents, in partnership with Regulatory Affairs
- Serve as the clinical pharmacology representative in interactions with FDA and other health authorities, including Type B/C meetings, briefing document preparation, and responses to information requests
- Apply model-informed drug development (MIDD) approaches, including PBPK modeling and biomarker strategy, to inform dose and development decisions
- Partner closely with Clinical Development, Biometrics, Regulatory Affairs, and CMC to ensure clinical pharmacology and DMPK considerations are built into trial design and regulatory decisions from the outset
- Serve as the primary hands-on contributor for clinical pharmacology and DMPK activities in the near term, working closely with CROs and consultants to execute analyses and deliverables, and ultimately hire and lead a small internal clinical pharmacology team as the portfolio grows
- Manage CRO relationships supporting clinical pharmacology and DMPK activities
Requirements:
- PhD, PharmD, or equivalent advanced degree in pharmacology, translational sciences, or a related field
- 15+ years of clinical pharmacology experience in biotech or pharma, including leading clinical pharmacology strategy across clinical trials with oversight of DMPK
- Oncology therapeutic area experience required
- Strong cross-functional collaboration skills, particularly with Clinical Development, Biometrics, Regulatory Affairs, and CMC
- Demonstrated experience managing CRO and consultant relationships as the primary means of executing clinical pharmacology and DMPK work
- Comfortable operating in a fast-paced, dynamic environment with a proactive, roll-up-your-sleeves mindset
- Legally authorized to work in the United States
