VP, Clinical Pharmacology

Frontier Medicines Corporation; Boston (MA); On-site; USD 275,000 - 345,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan (401k, IRA)

Life Insurance (Basic, Voluntary &

Paid Time Off (Vacation, Sick &

Family Leave (Maternity, Paternity)

Short Term & Long Term Disability

Training & Development

Free Food & Snacks

Wellness Resources

Stock Option Plan

Job summary

Frontier Medicines Corporation seeks a VP, Clinical Pharmacology to set strategy across oncology programs, spanning nonclinical and clinical pharmacology, bioanalysis, and DMPK. You will shape trial design, dose optimization, and regulatory input while partnering with CMC and Regulatory Affairs.

The role requires 15+ years in clinical pharmacology within biotech/pharma, with strong CRO management and a record of cross-functional leadership in fast-paced environments.

Qualifications

• PhD, PharmD or equivalent advanced degree in pharmacology or translational sciences or related field.
• 15+ years of clinical pharmacology experience in biotech or pharma, with leadership of strategy across trials and DMPK.
• Oncology therapeutic area experience is required.
• Strong cross-functional collaboration skills with Clinical Development, Regulatory Affairs, Biometrics, and CMC.
• Experience managing CROs and consultants as the primary execution method; US work authorization.

Responsibilities

• Lead clinical pharmacology strategy across active clinical trials, including dose selection and PK/PD analyses.
• Oversee nonclinical and clinical bioanalytical strategies and execution.
• Oversee DMPK activities in support of clinical and nonclinical programs.
• Provide input into CMC decisions, including formulation strategy and drug–drug interaction risk.
• Lead development of clinical pharmacology content for regulatory submissions (IND/CTA) in partnership with Regulatory Affairs.
• Represent clinical pharmacology in interactions with FDA and health authorities, including meetings and briefing documents.
• Apply model-informed drug development approaches (PBPK) to inform dose and development decisions.
• Partner with Clinical Development, Biometrics, Regulatory Affairs, and CMC to integrate considerations into trial design.
• Serve as hands-on contributor for clinical pharmacology and DMPK, potentially building an internal team and managing CROs.

Skills

Cross-functional collaboration

CRO management

Leadership

Clinical pharmacology

Oncology experience

Education

PhD or PharmD

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.