VP, Clinical Pharmacology

RA Cap; Boston (MA); On-site; USD 275,000 - 345,000; Full time

Benefits offered by this job

Health plan

401k plan

Life Insurance

Paid time off

Family leave

Disability insurance

Training & development

Free food & snacks

Wellness resources

Stock option plan

Job summary

Frontier is seeking a VP, Clinical Pharmacology to lead strategy across our oncology portfolio, spanning nonclinical PK/PD/ADME, and clinical pharmacology for active trials. This senior role partners with Clinical Development, Regulatory, Biometrics, and CMC to shape dose selection, regulatory strategy, and trial design.

The successful candidate will build the function, manage CROs, and eventually lead a small internal team while collaborating with FDA and other health authorities.

Qualifications

• PhD, PharmD or equivalent advanced degree in pharmacology or related field.
• 15+ years in clinical pharmacology within biotech/pharma with DMPK oversight.
• Oncology experience and cross-functional collaboration required.

Responsibilities

• Lead clinical pharmacology strategy across trials, including dose selection and exposure-response analyses.
• Oversee nonclinical and clinical bioanalytical strategies and execution.
• Oversee DMPK activities in support of program needs.
• Provide input into CMC decisions, including formulation strategy and DDIs.
• Develop content for regulatory submissions (IND/CTA) with Regulatory Affairs.
• Represent clinical pharmacology in FDA interactions and briefing documents.
• Apply MIDD approaches, PBPK modeling, and biomarker strategy.
• Partner with Clinical Development, Biometrics, Regulatory, and CMC to embed pharmacology in trial design.
• Lead CRO relationships and eventually build an internal team for pharmacology/DMPK.
• Manage CRO relationships supporting pharmacology and DMPK activities.

Skills

Strategic leadership

Cross-functional collab

CRO management

Regulatory liaison

Pharmacology expertise

Education

PhD/PharmD or equivalent

Job description

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.

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.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Training & Development
• Free Food & Snacks
• Wellness Resources
• Stock Option Plan

At Frontier, we strive to build a diverse and equitable workplace. The salary range for this role is $275,000 - $345,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.

This compensation and benefits information is based on Frontier's knowledge as of the date of publication, and may be modified in the future.