Senior Vice President, Regulatory Science – Clinical Regulatory Affairs
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Job Description
Parexel regulatory science leader guiding clinical drug development and regulatory strategy for biopharma clients. Leading expert teams, advising executives, and representing clients to regulatory agencies.
Responsibilities:
- 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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