Senior Director, Clinical Pharmacology & PK/PD Modeling

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

Benefits offered by this job

Hybrid schedule

Competitive health coverage

Paid time off

Job summary

Beeline Medicines is seeking a Senior Director of Clinical Pharmacology to lead PK/PD strategy across programs, guide modeling and simulation, and inform dose selection for regulatory submissions. The role interfaces with cross‑functional teams and regulators, driving strategy and ensuring scientific rigor.

The position requires a PharmD or PhD in Clinical Pharmacology (or related), 10+ years in clinical pharmacology, and strong vendor management.

Qualifications

• Education required as listed (PharmD or PhD in Clinical Pharmacology or related field).
• 10+ years in clinical pharmacology with leadership of PK/PD strategy across development‑stage programs.
• 3+ years vendor management overseeing CROs/vendors.
• Experience in immunology/inflammation/immune‑mediated diseases preferred.
• Expertise in population PK/PD modeling and software (e.g., NONMEM, R).

Responsibilities

• Lead clinical pharmacology strategy for assigned programs and dose‑selection rationale.
• Direct population PK, exposure‑response, and modeling/simulation analyses.
• Author/review clinical pharmacology sections of INDs, NDAs/BLAs, and regulatory responses.
• Serve as clinical pharmacology lead on cross‑functional program teams.
• Represent pharmacology in meetings with regulators (FDA/EMA) and briefing documents.
• Provide pharmacology assessments for due diligence and licensing.
• Oversee CROs and modeling vendor relationships and deliverables.
• Perform other duties as assigned.

Skills

PK/PD strategy

Population PK

Modeling & simulation

Regulatory interactions

Vendor management

Cross-functional collaboration

Scientific writing

Education

PharmD or PhD in Clinical Pharmacology or related discipline

Tools

NONMEM

R

Job description

Beeline Medicines is seeking a Senior Director of Clinical Pharmacology to lead PK/PD strategy across programs, guide modeling and simulation, and inform dose selection for regulatory submissions. The role interfaces with cross‑functional teams and regulators, driving strategy and ensuring scientific rigor.

The position requires a PharmD or PhD in Clinical Pharmacology (or related), 10+ years in clinical pharmacology, and strong vendor management.