Executive Director of Medical Affairs

Remote, United States
Medical Affairs /
Permanent, full-time /
Remote
Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, and more accurate. 

At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can make genomics globally accessible. Our people are keen to take responsibility for their work and share both their successes and challenges. 

Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including medical, dental and vision coverage, 401(k), bonus, stock options, life insurance,  short-term and long-term disability income protection, 20 days per year PTO allowance and 2 floating holidays in addition to Company observed holidays.

Biofidelity is looking for a dynamic, efficient and results-oriented  Executive Director of Medical Affairs with a strong background in oncology molecular diagnostics to support the planning, development and execution of our medical affairs strategy.  This position reports to the Chief Medical Officer. 

Key responsibilities:
      Lead Global KOL and SAB engagement to support clinical and commercial objectives by representing Biofidelity in regional and national scientific conferences, Advisory meetings, Webinars and 1:1 discussions.  
      Provide strategic and hands-on internal and external executional leadership for the medical affairs function to support our molecular oncology products
      Provide clinical leadership for regulatory and  reimbursement
      Partner with commercial team in building engagement with leading key opinion leaders including oncologists, pathologists, pulmonologists, patient advocacy groups, diagnostic laboratories, contract research organizations and pharma as we create strategies for product development, reimbursement, innovation, evidence generation and research
      Lead and execute publication strategy and reference library management to support clinical engagement and commercial requirements  
      Serve as a clinical leader in aggregating scientific, medical and technical customer-focused insights and strategic perspectives related to molecular diagnostic oncology products and initiatives 
      Align with brand and launch team on cross-functional team representation with the goal of developing and implementing integrated clinical and commercial strategies for Biofidelity’s products to enhance our corporate image and increase understanding of Biofidelity’s oncology/molecular clinical applications 
      Based on product priorities and research strategies, establish, and drive a clinical and scientific agenda, by engaging researchers through Biofidelity’s activities and partnerships, including conducting studies that lead to publications in support of Biofidelity’s product objectives
      Coordinate and lead advisory boards and round tables to gather clinical insights to enable the sharing of clinical knowledge with and between internal and external stakeholders
      Lead medical review and provide input on promotional and other materials in accordance with appropriate regulations
      Support customer service in our CLIA lab
      Support tumor bank tissue planning and acquisition 
 
Knowledge, Skills, And Abilities:
      Technical and working knowledge of the basics of molecular pathology, cancer genomics and oncology diagnostics  
      Knowledge of NGS and other genomic testing modalities
      Clinical knowledge of NSCLC practice guidelines 
      Knowledge of publication best practices, management of reference library, and ability to lead publication strategy 
      Knowledge of oncology and molecular diagnostics,  pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to clinical operations, commercial, translational,  regulatory, and medical affairs
      Understanding of compliance between commercial and clinical functions,  RUO vs LDT 
      Demonstrated experience with leadership in stakeholder engagement (e.g., KOLs, advocacy groups, payers, regulatory authorities) 
      Outstanding written and verbal communication skills
      Strategic thinker with ability to focus on specific tactical needs and operational side of the role as we build the team
      High degree of self-motivation and ability to work independently, willingness to work in a dynamic start-up environment
      Solution-oriented, result driven, with strong attention to detail
      Demonstrated experience working cross-functionally and collaboratively across different teams and geographies
      Cross-cultural awareness, ability to thrive in a small, dynamic and rapidly growing company environment
      Ability to travel up to 30% time
 
Requisite Education and Experience/Minimum Qualifications:
      MD plus accredited fellowship in molecular pathology and 2 + year of Medical Affairs or related pharmaceutical industry experience in oncology genomic diagnostics 
      OR PhD molecular pathologist  OR other advanced clinical degree, with equivalent and relevant medical training  and 4 + years of pathology Medical Affairs experience or related pharmaceutical industry experience in oncology genomic diagnostics
      Experience with molecular oncology diagnostic development, oncology clinical biomarker development, and Next Generation Sequencing platforms
      Medical Affairs or related  experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
      Prior product launch experience within diagnostics 
      Experience working with drug development teams to understand diagnostic needs and develop strategic diagnostic plans (desired)
 
The expected, full-time, annual base salary range for this position is $200,000-$320,000. The actual base salary will vary based on factors including qualifications, experience and location. At Biofidelity, we take a market-based approach to compensation to ensure we are objective, equitable and competitive.