Executive Director/VP Medical Affairs - Global Medical Affairs Lead (GMAL)
Biofidelity’s mission is to improve and extend cancer patients’ lives by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care.
At Biofidelity we are proud to have built a culture of teamwork, openness and trust. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges.
Biofidelity is looking for a dynamic, efficient and results-oriented Global Executive Director/VP Medical Affairs (GMAL) to lead the planning, development and execution of our global medical affairs strategy for our first diagnostic product launch. This key position will be responsible for building the Medical Affairs Franchise, both in the US and ex-US. This position reports to the Chief Medical Officer.
Design, develop and deliver global medical affairs strategy for launch of our first product
Lead tactical and strategic execution for medical affairs functions in both US and ex-US.
Partner with commercial and marketing teams in building engagement with leading key opinion leaders including oncologists and hematologists, patient advocacy groups, pathologists, diagnostic laboratories and pharma as we create strategies for product development, innovation, evidence generation and research
Serve as a clinical global leader in aggregating scientific, clinical, and technical customer-focused insights and strategic perspectives related to 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 where appropriate, conducting studies that lead to publications in support of Biofidelity’s product objectives
Coordinate and manage advisory boards to gather clinical insights as well as round tables to enable the sharing of clinical knowledge with and between external stakeholders
Lead review and provide medical input on promotional and other materials in accordance with appropriate regulations
Represent Biofidelity at regional and national scientific conferences
Knowledge, Skills, And Abilities:
Proven strategic and leadership capabilities of building Medical Affairs infrastructure and building teams
Solid foundation in translational medicine, genomics, molecular and cancer biology
Knowledge of oncology and diagnostic pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to clinical operations, commercial, translational, regulatory, and medical affairs
Demonstrated experience with stakeholder engagement (e.g., KOLs, advocacy groups, payers) with an established network and profile in the sector
Outstanding written and verbal communication skills
Requisite Education and Experience/Minimum Qualifications:
MD plus accredited fellowship in Oncology, Hematology or Pathology OR PhD OR PharmD with equivalent and relevant medical training
5+ years of Medical Affairs experience or related pharmaceutical industry experience
Experience with diagnostic development, oncology and hematology clinical biomarker development, and Next Generation Sequencing platforms
Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
Experience in developing and delivering companion diagnostic submissions work plans, data packages, and PMA submissions (desired)
Prior product launch experience within diagnostics (desired)
Experience working with drug development teams to understand diagnostic needs and develop strategic diagnostic plans (desired)
Experience in leading publication planning (desired)