Director, Medical Affairs

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.

At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Our proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).

Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.

Be part of making a difference. Be part of Invivyd.

Invivyd is seeking a passionate Director, Medical Affairs who will work closely with the VP, Medical Affairs and other departments to lead and execute the company’s Medical Affairs strategy. S(he) will be responsible for designing medical strategies and implementing tactical plans while providing thought leadership internally and externally.

Reporting to the Senior Director, Medical Affairs the Director, Medical Affairs will function as a key partner with preclinical development, clinical development, commercial, legal and regulatory to develop strategies for our authorized product(s), including life cycle management, ensuring consistency of approach and quality scientific deliverables. S(he) will ensure development and execution of medical plans to achieve short term and long-term objectives. Additionally, the Director, Medical Affairs will have a close partnership with the Medical Science Liaison team.

In this role you will be responsible for strategy and execution of the Medical Affairs annual plan.

This position will work collaboratively across preclinical and clinical teams, commercial, legal, and regulatory to ensure planning, execution, and delivery of the strategy for authorized products and pipeline candidates.

Responsibilities:

Medical Affairs Strategy

• Contributes to Medical Affairs strategic plan
• Implements the Medical Affairs plan including elements of medical communications, medical education, MSL strategy, and external engagement
• Presents scientific data at internal and external meetings (e.g. advisory boards, investigator meetings, and professional associations)
• Evaluates, distills, and appropriately communicates medical and scientific intelligence
• Anticipates future industry trends and opportunities, proactively developing plans to address through Medical Affairs strategy

Medical Communications

• Develops and reviews abstracts, manuscripts, posters and slides for internal and external scientific meetings and field medical use
• Ensures the implementation of core messages into presentations and written materials; aligns cross-functionally on messaging
• Works closely with commercial and clinical development/regulatory in designing and implementing launch strategies and tactics as well as life cycle planning
• Develops strategic imperatives and tactical plans to enhance healthcare practitioner education to improve patient outcomes
• Provides strategic direction and scientific support to the MSL team
• Fully understands and applies MSL SOP's/guidelines/Regulatory/Legal guidelines
• Helps foster MSL excellence and collaborations

Medical Education

• Establishes medical education strategy, with input from the team
• Operationalizes the medical education plan, within compliant framework, including approval of grants according to SOPs
• Maintains relationships with medical education providers and documentation associated with programs
• Excellent communication (verbal, written, presentation), interpersonal, and relationship-building skills; ability to effectively translate information and facilitate agreement across diverse groups internally and externally
• Demonstrated ability in project management, objective setting and plan execution; ability to work on multiple projects simultaneously and effectively prioritize workload
• Innovative thinker who sees the big picture and can drive operational execution
• Self-starter and team player with a strong results orientation
• Strong organizational and analytical skills; ability to understand and interpret scientific research
• Strong strategic problem-solving and risk mitigation skills
• Ability to flexibly adapt to changing business needs; comfortable with ambiguity
• Ability to identify and understand complex issues and identify key findings from study data and publications
• Organized, able to meet timelines in fast-paced environment with strong attention to detail
• Must be fully knowledgeable of regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities, including a thorough knowledge of FDA regulations and other industry standard guidance such as ICMJE.

Requirements:

• Minimum of 8 years Medical Affairs experience within biotech/pharma
• Advanced degree (MD, PharmD) with specialization in infectious diseases or pulmonary/critical care preferred
• Experience developing and managing health care provider relationships, including knowledge of regulations as they relate to such interactions
• Demonstrable success working in highly matrixed, cross-functional environment requiring excellent cross functional collaboration to achieve successful results
• Demonstrated track record building and leading teams
• 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
• Strong clinical/scientific background/aptitude
• Ability to anticipate and adapt to change
• Excellent abilities to follow complex direction/processes under pressure and proficient balancing multiple routine tasks simultaneously to achieve goals
• Strong organizational skills, with attention to detail as well as ability to independently determine and develop approaches to non-routine problems – a self-starter

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.

Invivyd is proud to be an equal opportunity employer.