Senior Vice President, Regulatory Science – Clinical Regulatory Affairs

🔥 20 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 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

• Create opportunities for clients throughout the product lifecycle by applying scientific, technical, regulatory, and/or commercial expertise • Lead teams of subject-matter experts and provide mentoring and guidance to RS employees • Provide a full range of consulting services within the individual's area of expertise • Participate in developing new service offerings, consulting models, and methodologies • Work individually or within teams according to project needs • Lead issue and conflict resolution and prioritize project and team workloads • Improve project efficiency, results, and team performance • Produce and review high-quality work meeting Parexel and client expectations • Manage small and large project engagements • Coordinate with Project Assistants on financial management and project support • Present speeches and seminars to industry groups and author industry publications • Contribute expertise to professional societies, academic groups, and industry associations • Facilitate improvements to Parexel business processes • Provide technical and/or business consulting services, including representing clients to regulatory agencies • Act as a trusted advisor and, when required, a loaned executive for clients • Develop and implement business solutions addressing client needs • Present to client boards and provide strategic advice to C-suite executives • Identify follow-on business and scope-change opportunities

🎯 Requirements

• MD or PhD required • 15+ years of experience with expert-level industry or regulatory knowledge in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications • Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior/Master Medical Review Officer, Team Lead, or related Medical role strongly preferred • Subject-matter experts with industry experience will also be considered • Extensive General Medicine, Neuroscience, Endocrinology, or Immunology/Rheumatology experience highly preferred • Ability to travel up to 20–30% domestically and/or internationally may be required • Internationally recognized professional in the relevant field of expertise • Fully proven rainmaking skills and relationships at senior levels within client organizations • Thorough understanding of Parexel's consulting models, methodologies, and Regulatory Strategy services

🏖️ Benefits

• Work/life balance while working from home • Opportunity for career advancement • Ability to work from home

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