As the VP of Clinical Affairs, you will report to the Chief Medical Officer to lead the continued build out and management of Cognoa’s Clinical Affairs team. The Clinical Affairs team has broad responsibility for Clinical Development, Clinical Operations, Clinical Product Management, HEOR, and Real World Evidence. This position is being considered for a Vice President level and would include oversight of several direct reports of varying levels.
The Vice President of Clinical Affairs will create the overall clinical program strategy for early development through life cycle management, developing and overseeing the execution of the clinical study portfolio designed to meet objectives of a platform in pediatric behavioral health (example: Autism Spectrum Disorder). This role provides strategic leadership and works closely with cross-functional leadership that includes Medical Affairs, Regulatory, Commercial, Product, Engineering, and Data Sciences to ensure that the Clinical Affairs scientific and medical strategies are aligned with broader corporate and patient needs. Close collaboration will be needed with the global experts in each given field to ensure patient voice, clinical and value impact, and regulatory inputs are incorporated. A strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards is critical.
- Serve as a key leader of the Clinical Affairs organization and provide clinical development advice and counsel to Cognoa governing and oversight bodies as needed.
- Provide strategic oversight to Clinical Operations, Clinical Product, Clinical Development, and HEOR and Real World Evidence teams.
- Manage and direct multiple clinical programs in various stages of development, while guiding the larger strategy and Clinical Development Plan.
- Lead program teams to design and implement clinical studies to deliver on the strategic vision and address patient needs.
- Oversee development of protocols in close cross functional and external collaborative manner
- Provide insight to pipeline determination in clinical feasibility, and translate findings from research and nonclinical studies into clinical development opportunities
- Ensure cross functional alignment for Clinical Affairs needs across – Medical Affairs, Regulatory, Commercial, Product, Engineering, and Data Sciences.
- Highly specialized degree – MD or PhD – with 5+ years experience in pediatric neurodevelopmental disorders strongly preferred.
- Experience in Medical Device industry required, diagnostics experience preferred.
- A minimum of 15 years of experience within clinical development and translational sciences.
- Proven clinical development strategist with experience designing, implementing and conducting clinical trials Prior product launch experience.
- 6+ years of experience in leading and managing teams strongly preferred.
- Strategic leadership and communication skills, strong initiative, ethics, and judgment, and demonstrated ability to positively represent the goals of Cognoa.
- Possess an understanding of applicable US Medical Device development regulations.
- Must have the ability to travel (20%).