Vice President, Regulatory Science - Clinical Pharmacology SME

Job overview

The Vice President, Regulatory Science - Clinical Pharmacology SME is an onsite role based in Austin, TX, with compensation not specified. This position is part of the Regulatory Consulting team at Parexel, a global leader in clinical development solutions. This role exists to provide expert-level strategic consulting to biopharmaceutical companies. The Vice President serves as a trusted advisor, leveraging their regulatory agency experience to guide clients through complex clinical pharmacology strategies, regulatory development plans, and Health Authority interactions.

What you'll do

• Provide expert consulting in Clinical Pharmacology, Translational Medicine, and Regulatory Strategy.
• Lead complex client engagements and represent clients before regulatory agencies.
• Advise on dose selection, exposure-response analyses, and pediatric development plans.
• Assess development plans for INDs, NDAs, and BLAs.
• Contribute to industry thought leadership through publications and presentations.

What we're looking for

Skills & competencies

full-time

day shift

austin tx

parexel

regulatory science

clinical pharmacology

sme

executive

consulting

biotech

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, vision, dental, 401(k) with match, tuition reimbursement, flexible spending accounts.

Why this role

Requires MD or PharmD; significant experience within a regulatory agency (FDA, EMA, etc.) is required.

About the employer

Parexel is hiring for this role. Industry: Offices of All Other Miscellaneous Health Practitioners. Sector: 62.