VP, Clinical Pharmacology

What's in it for you?

Frontier is seeking a VP, Clinical Pharmacology to lead clinical pharmacology strategy across our oncology clinical portfolio. This is a senior, cross-functional leadership role spanning 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.

This individual will serve as Frontier's senior-most clinical pharmacology leader, setting strategy and building out the function and 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 our oncology programs.

Requirements

• What will you be doing?
• 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 the 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.
• What are we looking for?
• 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. This role will operate this way initially, before building an internal team.
• Comfortable operating in a fast-paced, dynamic environment with a proactive, roll-up-your-sleeves mindset.
• Legally authorized to work in the United States.