Sr. Director, Clinical Pharmacology & PK/PD Strategy

Beeline Medicines; Boston (MA); Hybrid; USD 266,000 - 344,000; Full time

Benefits offered by this job

Hybrid work schedule

Health benefits

Equity / long-term incentive

Job summary

Beeline Medicines in the United States seeks a Senior Director, Clinical Pharmacology to lead PK/PD strategy across development programs. You will oversee population PK, exposure‑response modeling, and dose‑selection, manage CROs, and prepare regulatory submissions.

You'll interact with health authorities and guide cross‑functional teams to advance innovative therapies for immune‑mediated diseases. This hybrid role requires leadership, exceptional scientific writing, and ability to coordinate

Qualifications

• 10+ years of clinical pharmacology experience with leadership across programs.
• Experience managing CROs and modeling vendors.
• Strong regulatory writing and health authority interaction skills.

Responsibilities

• Lead clinical pharmacology strategy across programs.
• Direct population PK, exposure‑response analyses and modeling.
• Author sections of INDs, NDAs/BLAs and health authority responses.
• Serve as clinical pharmacology lead on cross‑functional teams; advise on drug‑drug interaction studies.
• Represent clinical pharmacology in meetings with health authorities (FDA/CHMP).
• Provide clinical pharmacology assessments for due diligence and licensing.
• Oversee CROs and modeling vendor relationships and deliverables.
• Manage timelines, risks, and deliverables across programs.

Skills

Clinical Pharmacology

PK/PD Modeling

Population PK

Regulatory Submissions

Vendor Management

Modeling & Simulation

Regulatory Meetings

Project Management

Communication

CRO Oversight

Education

PharmD/PhD in Clinical Pharmacology or related

Tools

NONMEM

R

Job description

Beeline Medicines in the United States seeks a Senior Director, Clinical Pharmacology to lead PK/PD strategy across development programs. You will oversee population PK, exposure‑response modeling, and dose‑selection, manage CROs, and prepare regulatory submissions.

You'll interact with health authorities and guide cross‑functional teams to advance innovative therapies for immune‑mediated diseases. This hybrid role requires leadership, exceptional scientific writing, and ability to coordinate