Senior Manager, Medical Affairs

Invivyd Inc, is seeking a passionate Senior Manager, Medical Affairs who will work closely with others in the department to support the company’s Medical Affairs function. S(he) will be responsible for supporting design of medical strategies and implementing tactical plans. S(he) will provide leadership to medical communication plans including medical information, medical content and publications.  Additionally, s(he) will support medical affairs strategy through medical and promotional review processes.

Reporting to the Senior Director of Medical Affairs the Senior Manager, Medical Affairs will execute tactics and function as a key cross functional partner with Clinical Development, Commercial, Regulatory, and Legal on launch plans and life cycle management. S(he) will ensure consistency of approach and quality scientific deliverables. Additionally, the Senior Manager, Medical Affairs will have a close partnership with the Medical Science Liaison team.

Responsibilities:

• In collaboration with the Medical Affairs team, operationalizes tactical plan built from strategic imperatives
• Supports the global Medical Affairs plan including medical communications, medical information, congresses/conference planning, and the MSL team
• Will place a particular emphasis on managing Medical Information: development of standard and custom response letters, escalations and providing overview of metrics.
• Will operationally support publications: including tracking of timelines, review cycles, vendor management.
• Owns the medical review committee including planning, disseminating, adjudication of reviews
• Reviews and approves medical and commercial materials, working with legal and regulatory counterparts
• Monitors and communicates progress on timelines related to strategic projects within Medical Affairs
• Supports contracting for Medical Affairs function
• Provides input into various cross-functional projects, such as advisory boards and competitive intelligence
• Provides project management support including management of external vendors, project budget, and coordination with internal Invivyd groups
• Evaluates, distills, and appropriately communicates continuously expanding medical and scientific information
• Brings creativity to the role, advises on technology/digital solutions that may be of benefit to Medical Affairs
• Has ability to take on initiatives beyond this initial scope as needed and as the department grows

Requirements: 

• Minimum of 3 to 5 years Medical Affairs experience within biotech/pharma
• Advanced degree (PharmD, PhD) with specialization in infectious diseases or immunology preferred
• Demonstrable success working in highly matrixed, cross-functional environment requiring excellent cross functional collaboration to achieve successful results
• Strong interpersonal skills commensurate with the need to work closely with partners, KOL's, consultants, and team members across functions
• Strong writing and presentation skills
• Ability to identify and understand complex issues and identify key findings from study data and publications
• Ability to assess situations to determine the importance, urgency and risks, and then present the team with recommendations is required
• Demonstrated ability in project management, objective setting and plan execution; Ability to work on multiple projects simultaneously and effectively prioritize workload
• Ability to flexibly adapt to changing business needs
• Self-starter and team player with a strong results orientation
• Strong analytical skills with ability to understand and interpret scientific research
• Organized, able to meet timelines in fast-paced environment with strong attention to detail
• Must be knowledgeable of regulatory and legal requirements for Medical Affairs activities, including industry standard guidance such as ICMJE.
• Must adhere to all applicable SOPs, laws, and regulations for compliance and quality

At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.