Senior 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

Discretionary bonus

Long-term incentive (equity)

Comprehensive benefits

Job summary

Beeline Medicines is seeking a Senior Director, Clinical Pharmacology to lead PK/PD strategy across development programs, oversee modeling and simulation, and guide dose selection for regulatory submissions. This role requires hands-on expertise and strategic leadership across cross-functional teams.

You will lead population PK, exposure–response analyses, manage CROs, and defend strategies with health authorities in meetings and responses.

Qualifications

• PharmD or PhD in Clinical Pharmacology or related field.
• 10+ years of clinical pharmacology experience with leadership of PK/PD strategy.
• 3+ years of vendor management oversight with CROs.
• Experience in immunology or related therapeutic areas preferred.
• Expertise in population PK/PD modeling and software (NONMEM, R).
• Strong knowledge of ICH and FDA/EMA guidance.

Responsibilities

• Lead clinical pharmacology strategy for development programs.
• Oversee population PK, exposure–response, and modeling analyses.
• Prepare and review sections of INDs, NDAs/BLAs.
• Represent pharmacology in health authority meetings.
• Manage CROs and vendor relationships.

Skills

PK/PD modeling

Leadership

Vendor management

IND/NDA/BLAs

ICH FDA guidance

Education

PharmD or PhD in Clinical Pharmacology

Tools

NONMEM

R

Job description

Beeline Medicines is seeking a Senior Director, Clinical Pharmacology to lead PK/PD strategy across development programs, oversee modeling and simulation, and guide dose selection for regulatory submissions. This role requires hands-on expertise and strategic leadership across cross-functional teams.

You will lead population PK, exposure–response analyses, manage CROs, and defend strategies with health authorities in meetings and responses.