Vice President, Regulatory Science - Clinical Pharmacology SME

Job overview

The Vice President, Regulatory Science - Clinical Pharmacology SME is an onsite role based in Harrisburg, PA. Compensation is not specified for this position, which supports the Regulatory Consulting team at Parexel. This role serves as a strategic advisor to biopharmaceutical companies, leveraging deep regulatory expertise to guide clinical pharmacology strategies and Health Authority interactions. The VP provides expert-level consulting to navigate complex development programs and influence drug development strategies across therapeutic areas.

What you'll do

• Provides expert-level consulting in Clinical Pharmacology, Translational Medicine, and Regulatory Strategy.
• Leads complex client engagements and represents clients before regulatory agencies.
• Advises on clinical pharmacology strategies including dose selection and exposure-response analyses.
• Serves as a trusted advisor to executive-level client stakeholders.
• Assesses development plans and identifies regulatory considerations for INDs, NDAs, and BLAs.

What we're looking for

Skills & competencies

full-time

day shift

harrisburg pa

parexel

regulatory science

clinical pharmacology

strategic consulting

drug development

health authority

executive leadership

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, Vision & Dental Insurance, Tuition Reimbursement, 401(k) with match, Pet Insurance.

Why this role

Requires MD or PharmD; extensive experience within a regulatory agency like the FDA is highly preferred.

About the employer

Parexel is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.