Summary

You will report to the Chief Medical Officer to lead the continued build-out and management of Cognoa’s Medical Affairs team. The Medical Affairs team has broad responsibility for Scientific Communications, Field Engagement, Patient Advocacy, and Clinical Adoption. The Vice President of Medical Affairs will set the vision and direction for the Medical Affairs organization, leading the team across multiple asset programs. Should be recognized as an influential leader within and outside of the organization. Must be able to provide direction to senior leader’s cross-functionally and within Medical Affairs. The Medical Affairs team is being built ahead of Cognoa’s first commercial launch for an Autism Diagnostic Medical Device and will expand to support other portfolio needs over time.

The Vice President of Medical Affairs will be responsible for building and guiding a Medical Affairs function ahead of the organization’s first commercial launch. This role provides strategic leadership and works closely with cross-functional leadership that includes Clinical Affairs, Regulatory, Commercial, Product, Engineering, and Data Sciences to ensure that the Medical Affairs scientific and medical strategies are aligned with broader corporate and medical community 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.

Responsibilities

  • Serve as a key leader of the Medical Affairs organization and provide strategic guidance and to Cognoa governing and oversight bodies as needed.
  • Provide strategic oversight to ensure that Medical Affairs resources and activities are appropriately focused to deliver on strategic plans. Medical Affairs teams including Medical Operations, Med Comms., Scientific Communications, Field Medical (Regional Medical Directors and Medical Science Liaisons), Patient Advocacy, and Clinical Adoption.
  • Act as a strategic lead from the Medical perspective for the commercial launch of an Autism Diagnostic Medical Device.
  • Guide the development and alignment of Key Medical Objectives that will enable the larger Corporate Objectives.
  • Grow and scale the Medical Affairs function to support the larger needs of the organization as the product portfolio expands. Includes oversight of strategic initiatives needed for the build-out of Medical Affairs.
  • Provide insight to pipeline determination in clinical feasibility and translate findings from research and medical community into clinical development opportunities.
  • Ensure cross-functional alignment for Medical Affairs needs across – Clinical Affairs, Regulatory, Commercial, Product, Engineering, and Data Sciences.

Qualifications

  • MD or Ph.D. with 5+ years’ experience in pediatric neurodevelopment disorders strongly preferred.
  • Extensive Medical Device industry experience, 10-15 years spanning Medical Affairs and clinical development, with strong launch experience(s).
  • Must have US Medical Affairs leadership experience working with Commercial functions.
  • A minimum of 15 years of experience within clinical development and translational sciences.
  • 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.
  • Excellent and demonstrated interpersonal skills: the ability to understand and respond to multiple external and internal customers' demands, manage and handle conflict constructively required.
  • Must have the ability to travel (20%), location is flexible

Cognoa is an equal opportunity employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or another non-merit factor.