Company:  Confidential

Job Title: VP Clinical Development

Job Number: 75455

Location: Remote, US

Job Description

Responsibilities

* Lead the development of strategic scientific and medical input into clinical research programs and individual clinical trials * Collaborate with company Global Clinical Research teams to drive scientific content of protocols, clinical study reports, clinical investigator brochures, briefing books, orphan drug applications and other documents * In conjunction with Contract Research Organization (CRO) personnel, lead medical oversight of clinical research programs, including medical monitoring, safety evaluations, protocol deviations, and other required activities * Develop and maintain bank of external key opinion leaders and consultants related to company projects * Oversee and drive strategic statistical input into clinical research programs * Prepare and deliver scientific and medical presentations for key opinion leaders, regulatory authorities, and internal groups * Lead production of primary manuscript publications from completed clinical trials * Lead development and strategy team focused on cutting edge scientific and medical input * Maintain current knowledge of strategic trial design and data generation to include registries and real-world data generation in support of registration programs  * Represent company at key external scientific congresses, advisory boards, etc * Interacts internally with Global Clinical Research and Operations, Quality, Regulatory Affairs, Pharmacovigilance, Research and Development, Global Commercial, and Medical Affairs team members * External interactions include key opinion leaders, external regulatory agencies, consultants

Required Skills

* Advance degree in medical, pharmacy, or relevant scientific field (MD, * PharmD, PhD). Health sciences related degree preferred * Proven experience (15+ years) in industry clinical research trial design and  execution * Demonstrated experience interacting with global regulatory agencies (FDA,EMA, MHRA, etc.) * Excellent written and verbal communication skills * Documented personnel management experience * Familiarity with regulatory guidelines (e.g., Good Clinical Practice, ICH, FDA, EMA guidelines, etc.) * Attention to detail, strong organizational skills, and the ability to manage  multiple projects and deadlines effectively * Collaborative and adaptable team leader who can work effectively in a fast- paced, cross-functional environment * Based in the US * Willingness/ability to travel domestically and internationally when required

Application Deadline: 2024-05-13

 

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