VP, Regulatory Science & Clinical Pharmacology

Parexel; Austin (TX); Remote; USD 250,000 - 350,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation Time

FSA/HSA

Work/Life Balance

401(k) Match

Pet Insurance

Job summary

Parexel is seeking a Clinical Pharmacology SME to join our Regulatory Consulting team as a Vice President, Regulatory Science. If you have built your career at the FDA in Clinical Pharmacology, this role offers an opportunity to apply regulatory expertise across a diverse portfolio of development programs.

You will serve as a strategic advisor to biopharmaceutical companies, guiding clinical pharmacology strategies, regulatory development plans, and Health Authority interactions.

Qualifications

• MD or PharmD required; PhD a benefit.
• Extensive Clinical Pharmacology, Drug Development, Translational Medicine, or Regulatory Science experience.
• Experience with Health Authorities (FDA/EMA/MHRA etc.).
• Strong communication and client engagement skills.

Responsibilities

• Provide expert-level consulting in Clinical Pharmacology and Regulatory Strategy.
• Lead complex client engagements before regulatory agencies.
• Advise on clinical pharmacology strategies including first-in-human development and dose selection.
• Present strategic recommendations to senior leadership and navigate regulatory challenges.
• Assess development plans for regulatory considerations across INDs/CTAs/NDAs/BLAs/MAAs.
• Contribute to industry through conferences, publications, and thought leadership.

Skills

Clinical Pharmacology

Regulatory Strategy

Health Authority decisions

Strategic communication

Education

MD or PharmD

Job description

Parexel is seeking a Clinical Pharmacology SME to join our Regulatory Consulting team as a Vice President, Regulatory Science. If you have built your career at the FDA in Clinical Pharmacology, this role offers an opportunity to apply regulatory expertise across a diverse portfolio of development programs.

You will serve as a strategic advisor to biopharmaceutical companies, guiding clinical pharmacology strategies, regulatory development plans, and Health Authority interactions.