Remote Senior Director, Clinical Pharmacology (Oncology)

Paylocity; Northern (KY); Hybrid; USD 180,000 - 280,000; Full time

Job summary

BridgeBio Oncology Therapeutics is seeking a Director or Senior Director, Clinical Pharmacology to lead regulatory strategy and model-informed drug development across oncology programs. You will design and oversee PK/PD studies, guide regulatory submissions, and partner with cross-functional teams to drive clinical development in a fast-paced environment.

The role requires a Ph.D. in PK/PD or related field with 8+ years of oncology pharmacology experience, and a track record of FDA interactions

Qualifications

• Ph.D. in PK/PD or a related field with 8+ years in oncology pharmacology.
• Proven ability to lead regulatory submissions and FDA interactions.
• Experience in lean or startup environments is highly desirable.

Responsibilities

• Lead the clinical pharmacology strategy for oncology programs and ensure regulatory alignment.
• Design and oversee clinical pharmacology studies to support development plans.
• Collaborate with cross-functional teams to advance drug development programs.
• Apply MIDD approaches, including population PK/PD and exposure–response analyses.
• Author regulatory sections and serve as SME in interactions with FDA and health authorities.
• Interpret and communicate data to internal teams and external stakeholders.

Skills

Regulatory strategy

MIDD approaches

PK/PD modeling

Cross-functional leadership

Clinical pharmacology

Education

Ph.D. in PK/PD or related field

Tools

PBPK

PK/PD modeling

IND/NDAs drafting

Job description

BridgeBio Oncology Therapeutics is seeking a Director or Senior Director, Clinical Pharmacology to lead regulatory strategy and model-informed drug development across oncology programs. You will design and oversee PK/PD studies, guide regulatory submissions, and partner with cross-functional teams to drive clinical development in a fast-paced environment.

The role requires a Ph.D. in PK/PD or related field with 8+ years of oncology pharmacology experience, and a track record of FDA interactions