Associate Director/Director of Medical Affairs
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 Associate Director/Director of Medical Affairs to support the planning, development and execution of our medical affairs strategy. This position reports to the Chief Medical Officer.
Key responsibilities:
● Provide strategic and hands-on executional leadership for the medical affairs function to support our products
● Partner with commercial and marketing teams in building engagement with leading key opinion leaders including oncologists, patient advocacy groups, pathologists, diagnostic laboratories and pharma as we create strategies for product development, innovation, evidence generation and research
● Lead and execute publication strategy 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 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 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 medical review and provide input on promotional and other materials in accordance with appropriate regulations
● Represent Biofidelity at regional and national scientific conferences
● Support customer service in our CLIA lab
● Lead tumor bank tissue planning and acquisition
Knowledge, Skills, And Abilities:
● Technical and working knowledge of cancer genomics and basics of molecular biology
● 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 diagnostic pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to clinical operations, commercial, translational, regulatory, and medical affairs
● Understanding of best clinical practices for patient care
● Understanding of compliance between BD, RUO vs LDT
● Demonstrated experience with stakeholder engagement (e.g., KOLs, advocacy groups, payers)
● 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
● 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 Oncology, Hematology or Pathology and 1 + year of Medical Affairs experience or related pharmaceutical industry experience
● OR PhD OR PharmD and 2 + years of Medical Affairs experience or related pharmaceutical industry experience
● OR other advanced clinical degree, with equivalent and relevant medical training and 2 + years of Medical Affairs experience or related pharmaceutical industry experience
● Experience with diagnostic development, oncology 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
● Prior product launch experience within diagnostics (desired)
● Experience working with drug development teams to understand diagnostic needs and develop strategic diagnostic plans (desired)