Vice President, Regulatory Science – Clinical Pharmacology SME

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Vice President

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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 first-in-human development, dose selection, exposure-response analyses, population PK strategies, pediatric development plans, and special population studies • Serve as a trusted advisor to executive-level client stakeholders • Present strategic recommendations to senior leadership • Help clients navigate novel or precedent-setting regulatory challenges • Assess development plans and identify potential regulatory considerations • Advise on clinical pharmacology components of INDs, CTAs, NDAs, BLAs, MAAs, and supplemental applications • Contribute to industry advancement through scientific and regulatory conference presentations, peer-reviewed publications, professional organizations, internal mentoring, and knowledge sharing • Partner remotely with innovative biotech and pharmaceutical companies across therapeutic areas and product lifecycles

🎯 Requirements

• MD or PharmD required; PhD is a benefit • Extensive experience in Clinical Pharmacology, Drug Development, Translational Medicine, Clinical Development, or Regulatory Science • Significant experience within a regulatory agency such as FDA, EMA, MHRA, Health Canada, PMDA, or another major global Health Authority • Strong expertise in one or more areas including Clinical Pharmacology, PK/PD, Pharmacometrics, Translational Medicine, Clinical Development Strategy, or Regulatory Strategy • Deep expertise in Clinical Pharmacology, regulatory strategy, and Health Authority decision-making • Strong client relationship and executive communication skills • Strategic thinking and ability to guide sponsors through complex regulatory and scientific decision-making • Commitment to thought leadership through publications, presentations, and professional engagement • Patient-focused mindset and passion for advancing innovative therapies • Preferred: prior experience as a Clinical Pharmacology Reviewer, Master Reviewer, Team Lead, Medical Officer, or Division Leadership representative at the FDA or another Global Health Authority • Preferred: oncology experience and experience in one or more additional therapeutic areas • Preferred: demonstrated thought leadership through peer-reviewed publications, scientific conference presentations, professional organizations, or task forces • Willingness to travel domestically and internationally for client engagements, Health Authority meetings, scientific congresses, and industry conferences

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Additional benefit offerings in accordance with the terms of applicable plans • Some roles may be eligible for additional incentives, bonuses, or other compensation programs • Flexible work arrangement / remote work • Continuous learning opportunities