Medical Director - Boston Massachusetts

Company: Invivyd
Location: Boston, Massachusetts
Posted On: 05/03/2024

ABOUT US
Invivyd, Inc. (Nasdaq: IVVD) is a commercial-stage company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. The company's proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to keep pace with evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates.
THE HEART OF INVIVYD: OUR EMPLOYEES
Our team is motivated by a collective mission-driven sense of urgency that permeates Invivyd's culture. We make decisions quickly, trust employees in their areas of expertise, and collaborate efficiently. As a result, Invivyd employees are both quick thinkers and motivated doers.
Invivyd is a company comprised of motivated biopharmaceutical experts who are driven to make an impact on public health. Each employee sees working at Invivyd as a once-in-a-lifetime career opportunity to bring differentiated products to the market-for COVID-19, influenza and beyond. Our company operates as a hybrid company with employees working at our corporate headquarters in Waltham, Massachusetts and remotely. We have employees in over 25 states, with a critical mass in the greater Boston area and many employees in the northeast as well as California.
Job Title: Medical Director
Position summary:
Reporting to the Senior Vice President of Clinical Development, the Medical Director is a strategic leader and business partner responsible for overseeing clinical trials and the development strategy. This person will be responsible for providing medical and scientific expertise and oversight for clinical development programs and clinical trials, and serves as the point of accountability for design, execution, monitoring, delivery, and reporting of one or more clinical studies. The ideal candidate is someone who thrives in a fast-paced environment, who is a strategic problem solver, and who is proactive, flexible, detail-oriented, and hands-on.
Responsibilities include, but are not limited to, the following:

• In collaboration with other departments (Biometrics, Clinical Operations, Regulatory Affairs and Medical Affairs) lead the conception, study design, study protocols, medical monitoring and medical interpretation of Invivyd's clinical trials
  
• Lead the timely drafting of clinical responses to questions from regulatory authorities
  
• Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
  
• Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
  
• Develop and maintain close professional relationships with Key Thought Leaders and Healthcare Practitioners within the medical and scientific community.
  
• Provide impactful medical expertise to Clinical, Commercial, Market Access and Regulatory partners
  
• Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies
  
• Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards
  
• Conduct literature reviews and prepare summaries to support clinical development programs
  
• Serve as a medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
  
• Contribute to clinical trial documents including protocol, ICF, study plans and SAP
  
• May serve as a medical monitor for one or more studies
  
  Requirements:
  
  
  
  • MD with board certification in Immunology or Infectious Diseases strongly preferred; MD required
    
  • Experience with monoclonal antibodies or vaccines is required
    
  • Medical Monitoring experience required
    
  • Participation in successful regulatory approvals strongly preferred
    
  • Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects
    
  • Ability to motivate, influence and collaborate with others across all levels of the organization
    
  • Ability to engage internal and external experts in constructive scientific dialog around study design, conduct and data interpretation
    
  • Broad working knowledge of FDA requirements, industry compliance, clinical trial design and strategies
    
  • Experience in interacting with the FDA and/or global regulatory agencies.
    
  • Strong general knowledge of GCP, GPV, ICH guidelines and regulatory requirements that apply to clinical drug development
    
  • Able to conceive and execute innovative approaches to clinical development
    
  • Excellent written, communication and interpersonal skills and proven success working in a multi-functional team-based environment
    
  • Strong project planning, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems
    
  • Able to prioritize and parallel process multiple work streams, comfortable "shifting gears" and remaining flexible, as well as making definitive decisions
    
  • In-depth understanding of the scientific method and ability to apply this information to business needs based on medical and scientific rationale
    
  • Ability to travel domestically and internationally
    
    Additional Requirements:
    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.
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