Associate Director, Director of Medical Affairs

Summary

Join Biofidelity, a revolutionary genomic technology company, as an Associate Director/Director of Medical Affairs in oncology molecular diagnostics. You will lead global KOL and SAB engagement, provide strategic medical affairs leadership, and support regulatory and reimbursement efforts. Collaborate with the commercial team to build key opinion leader relationships and develop integrated clinical and commercial strategies. This role requires strong leadership, communication, and clinical expertise in oncology and molecular diagnostics. Biofidelity offers a competitive salary, comprehensive benefits, and opportunities for career development in a dynamic and growing company.

Requirements

• Technical and working knowledge of the basics of molecular pathology, cancer genomics and oncology diagnostics
• Knowledge of NGS, liquid biopsy and other genomic testing modalities
• Clinical knowledge of NSCLC practice guidelines and the ability to adapt and apply similar expertise to other oncology and disease areas as the portfolio expands
• 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)
• Understanding of patient advocacy and engagement to incorporate patient-centric insights into clinical and commercial strategies
• 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
• MD and 1+ year of Medical Affairs or related pharmaceutical industry experience in medical device, oncology genomic diagnostics
• OR PhD molecular pathologist OR other advanced clinical degree, with equivalent and relevant medical training and 2 + years of Medical Affairs experience pharmaceutical industry experience including launch and lifecycle management
• Medical Affairs or related experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with healthcare providers, integrated delivery networks, accountable care organizations, and/or payers

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 support 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
• Clinical leadership for 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
• Provide clinical input and oversight for clinical trial design, implementation, and data interpretation to support product development and regulatory approval
• Support customer service in our CLIA lab
• Support tumor bank tissue planning and acquisition

Benefits

• Competitive salary
• Opportunities for career development
• Medical, dental and vision coverage
• 401(k)
• Bonus
• Stock options
• Life insurance
• Short-term and long-term disability income protection
• 20 vacation days and 5 sick days per year PTO allowance
• 2 floating holidays in addition to Company observed holidays