Remote VP, Regulatory Science - Clinical Pharmacology

Parexel; United States; Remote; USD 200,000 - 300,000; Full time

Benefits offered by this job

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. We are expanding our Regulatory Consulting team with a Vice President, Regulatory Science role in Clinical Pharmacology.

As a Clinical Pharmacology SME, you will guide regulatory pharmacology strategies across portfolios, advise on INDs/CTAs/NDAs, and partner with global clients to shape development programs.

Qualifications

• MD, PharmD, or PhD required or preferred.
• Extensive experience in Clinical Pharmacology, Drug Development, Translational Medicine, Clinical Development, or Regulatory Science.
• Significant regulatory agency experience (FDA, EMA, MHRA, Health Canada, PMDA, etc.).

Responsibilities

• Provide expert-level consulting in Clinical Pharmacology, Translational Medicine, Clinical Development, and Regulatory Strategy.
• Lead complex client engagements and represent clients before regulatory agencies when appropriate.
• Advise on clinical pharmacology strategies including first-in-human development, dose selection, exposure–response analyses, and pediatric development plans.
• Serve as a trusted advisor to executive-level client stakeholders, presenting strategic recommendations to senior leadership.
• Assess development plans and identify regulatory considerations for INDs, CTAs, NDAs, BLAs, MAAs, and supplements.
• Contribute to industry advancement through publications, presentations, and mentoring.

Skills

Clinical Pharmacology

Regulatory Strategy

Executive communication

Thought Leadership

Education

MD or PharmD or PhD

Job description

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. We are expanding our Regulatory Consulting team with a Vice President, Regulatory Science role in Clinical Pharmacology.

As a Clinical Pharmacology SME, you will guide regulatory pharmacology strategies across portfolios, advise on INDs/CTAs/NDAs, and partner with global clients to shape development programs.