VP, Clinical Pharmacology

Frontier Medicines•Boston, MA

2d•$275,000 - $345,000

About The Position

Frontier is seeking a senior cross-functional leader to set clinical pharmacology strategy across its oncology clinical portfolio and build out the function. The role spans nonclinical pharmacology (PK/PD, ADME, and bioanalysis), clinical pharmacology for active trials (including bioanalysis, dose selection, and PK/PD strategy), DMPK oversight, and clinical pharmacology and biopharmaceutics input into CMC decisions. The VP will partner closely with Clinical Development, Regulatory Affairs, Biometrics, and CMC, contributing hands-on scientific expertise to trial design, dose optimization, and regulatory strategy. Initially, this person will directly contribute to clinical pharmacology and DMPK work and collaborate with CROs and consultants; as the portfolio grows, they will hire and lead a small internal team.

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.
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.
Comfort operating in a fast-paced, dynamic environment with a proactive, roll-up-your-sleeves mindset.
Legally authorized to work in the United States.

Responsibilities

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 supporting 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.
Represent clinical pharmacology in interactions with the FDA and other health authorities, including Type B/C meetings, briefing document preparation, and responses to information requests.
Apply model-informed drug development approaches, including PBPK modeling and biomarker strategy, to inform dose and development decisions.
Partner with Clinical Development, Biometrics, Regulatory Affairs, and CMC to incorporate clinical pharmacology and DMPK considerations into trial design and regulatory decisions.
Initially serve as the primary hands-on contributor for clinical pharmacology and DMPK activities, working with CROs and consultants to execute analyses and deliverables.
Build and lead a small internal clinical pharmacology team as the portfolio grows.
Manage CRO relationships supporting clinical pharmacology and DMPK activities.