Head of Clinical Pharmacology, PK/PD & Regulatory Strategy

BioSpace; Cambridge (MA); Hybrid; USD 266,000 - 344,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Hybrid work schedule

Job summary

Beeline Medicines in the United States is seeking a Senior Director, Clinical Pharmacology to provide leadership across development programs, directing PK/PD strategy, modeling and simulation, and dose‑selection activities to inform trial design and regulatory submissions.

Leads population PK, exposure‑response, and other quantitative modeling efforts and translates insights into dose‑selection rationale that shapes protocol design.

Qualifications

• 10+ years of clinical pharmacology experience in pharma/biotech, including leadership of PK/PD strategy across development-stage programs.
• 3+ years of vendor management oversight experience with ability to manage and hold CRO/modeling vendors accountable for deliverable quality.
• Experience in immunology, inflammation, autoimmune disease, immune-mediated diseases, T-cell biology, cell therapy, biologics, gene therapy, or other novel therapeutic modalities preferred
• Expertise in population PK/PD modeling and relevant software (e.g., NONMEM, R).
• Strong knowledge of ICH and FDA/EMA clinical pharmacology guidance.
• Understanding of drug-drug interaction and special population study design.
• Proven ability to lead clinical pharmacology strategy discussions with senior internal and external stakeholders, including regulators.
• Excellent scientific writing and presentation skills for regulatory submissions and health authority interactions.
• Skilled at defending clinical pharmacology strategy directly with health authorities.
• Demonstrated ability to manage external CROs/vendors and coordinate study execution across multiple stakeholders
• Strong project/program management capability, including timeline planning, cross-functional coordination, risk tracking, deliverable management, and issue escalation.
• Ability to communicate scientific and operational issues clearly to cross-functional teams and senior stakeholders.

Responsibilities

• Lead clinical pharmacology strategy for assigned programs, including PK/PD study design and dose-selection rationale.
• Direct population PK, exposure-response, and modeling and simulation analyses performed internally or by vendors.
• Author and review clinical pharmacology sections of INDs, NDAs/BLAs, and health authority responses.
• Serve as clinical pharmacology lead on cross-functional program teams, advising on drug-drug interaction and special population studies.
• Represent clinical pharmacology in interactions with health authorities (e.g., FDA/CHMP meetings), including authorship of relevant sections of briefing documents.
• Provide clinical pharmacology assessments to due diligence and licensing evaluations, as applicable.
• Oversee clinical pharmacology CRO and modeling vendor relationships and deliverables.

Skills

Leadership

PK/PD modeling

Modeling & simulation

Regulatory interactions

Vendor management

Cross-functional collaboration

Scientific writing

Presentation skills

Project management

Communication

Education

PharmD

PhD in Clinical Pharmacology

Pharmacokinetics

Pharmacometrics

Pharmaceutical sciences

Tools

NONMEM

R

Job description

Beeline Medicines in the United States is seeking a Senior Director, Clinical Pharmacology to provide leadership across development programs, directing PK/PD strategy, modeling and simulation, and dose‑selection activities to inform trial design and regulatory submissions.

Leads population PK, exposure‑response, and other quantitative modeling efforts and translates insights into dose‑selection rationale that shapes protocol design.