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Executive Director of Medical Affairs

Biofidelity

Biofidelity

Remote
Posted on Wednesday, November 1, 2023
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.