Director of Medical AffairsRemote, USA
Biofidelity’s mission is to improve and extend the lives of patients with cancer 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 humanity, openness and high expectations. 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.
Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including medical, dental and vision cover, 401(k), bonus, share option scheme, 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 Director of Medical Affairs to support the planning, development and execution of our US and global medical affairs strategy for our first diagnostic product launch. This position reports to the Chief Medical Officer.
Provide strategic and hands-on executional leadership for the medical affairs function to support launch of our first product
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 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 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 medical review and provide 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 in Medical Affairs functions
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
Strategic thinker with ability to focus on specific tactical needs and operational side of the role as we build the team
Cross-cultural awareness, ability to thrive in a small, dynamic and rapidly growing company environment
Ability to travel up to 30% time when safe to do so
Requisite Education and Experience/Minimum Qualifications:
Advanced degree: MD plus accredited fellowship in Oncology, Hematology or Pathology OR PhD OR PharmD OR other advanced clinical degree, with equivalent and relevant medical training
3 + 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)
To apply, please email your CV and cover letter to email@example.com
For informal enquiries about the post, please contact Ana Kukic, HR Business Partner, firstname.lastname@example.org.
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