Remote Director, Clinical Pharmacology Lead (Transplant)

Biogen, Inc.; Northern (KY); Hybrid; USD 209,000 - 288,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) with company match

Performance bonus and equity

Job summary

Biogen is seeking a Director, Clinical Pharmacology Lead to provide strategic leadership across the West Coast Hub transplant portfolio, focusing on pharmacology strategy, execution, and regulatory deliverables supporting late-stage development and BLA/NDA submissions.

You will lead pharmacology components for regulatory filings, guide cross-functional teams, and mentor the Clinical Pharmacology group to advance transplant and immunology programs within a dynamic, global biotech environment.

Qualifications

• 8+ years in industry with late-stage development
• Experience authoring regulatory submissions (BLAs/NDAs) and responding to information requests
• Leadership of Clinical Pharmacology for transplant/immunology programs

Responsibilities

• Represent Clinical Pharmacology on program teams and governance forums
• Develop integrated pharmacology strategies for dose selection and risk assessment
• Lead preparation of pharmacology components for regulatory submissions
• Provide strategic leadership for regulatory interactions with health authorities
• Drive regulatory risk identification and mitigation within pharmacology
• Lead pharmacology analyses including exposure–response and population PK
• Mentor and develop capabilities within the Clinical Pharmacology function
• Stay current with evolving pharmacology science and regulatory expectations

Skills

Clinical Pharmacology leadership

Regulatory submissions

Dose justification

Model-Informed Drug Development

Cross-functional leadership

Regulatory health authority

Education

PhD/MD/PharmD in Pharmacology or related

Job description

Biogen is seeking a Director, Clinical Pharmacology Lead to provide strategic leadership across the West Coast Hub transplant portfolio, focusing on pharmacology strategy, execution, and regulatory deliverables supporting late-stage development and BLA/NDA submissions.

You will lead pharmacology components for regulatory filings, guide cross-functional teams, and mentor the Clinical Pharmacology group to advance transplant and immunology programs within a dynamic, global biotech environment.