Senior Director, Medical Affairs

Cleveland Diagnostics•Cleveland, OH

1d•$125,000 - $225,000•Remote

About The Position

Cleveland Diagnostics is seeking a strategic, scientifically credible, and commercially minded Senior Director of Medical Affairs to lead and scale its medical affairs function. Reporting to the Chief Medical Officer, this executive will connect clinical science, key opinion leaders, payers, and the broader medical community, building the evidence base and clinical credibility needed to drive adoption of IsoPSA and pipeline products. The role is remote-eligible and requires travel to Cleveland, Ohio for one week per month. Cleveland Diagnostics is a precision diagnostics company focused on transforming the early detection and management of cancer. Its flagship product, IsoPSA, measures PSA by protein structure rather than concentration alone to provide a clinically meaningful signal for prostate cancer risk stratification. The company is advancing a pipeline of structure-based biomarker tests. The Senior Director will develop and execute medical affairs strategy, lead and mentor a multidisciplinary team, cultivate external scientific relationships, oversee evidence generation and dissemination, support payer and reimbursement strategy, and collaborate with commercial, clinical development, regulatory, and market access teams. The role will also establish medical affairs infrastructure and compliance frameworks appropriate for a growing organization. The position involves sitting, standing, and/or walking during the day; using a computer and multiple software and communication programs; using a telephone for several hours daily; driving and traveling by mass or air transit; and being able to use stairs if an elevator is unavailable. Work outside standard business hours may be required.

Requirements

MD, PhD, PharmD, or equivalent advanced degree.
10 or more years of progressive Medical Affairs experience within diagnostics, oncology, or medtech.
Leadership experience.
Proven track record building and leading MSL teams and engaging KOLs at a national or global level.
Experience supporting payer evidence strategies, including HEOR and value dossier development.
Strong scientific communication skills, including the ability to translate complex data for clinicians, payers, and patients.
Entrepreneurial mindset and ability to operate effectively in a lean, high-growth environment.
Working knowledge of OIG guidelines, the PhRMA Code, and medical affairs compliance requirements.
Ability to sit, stand, and/or walk throughout the day; operate a computer and multiple software, communication, and data-entry programs; use a telephone for several hours daily; safely drive and travel by available mass or air transit; and climb stairs if the elevator is unavailable.
Ability to work outside standard business hours when required.
Able to travel to Cleveland, Ohio one week per month.

Nice To Haves

Clinical training in urology, oncology, or internal medicine.
Deep understanding of the prostate cancer diagnostic landscape, including PSA-based testing, liquid biopsy, and guideline-driven care pathways.

Responsibilities

Design and execute the global Medical Affairs strategy for IsoPSA and pipeline diagnostics, aligned with commercial and regulatory objectives.
Build, lead, and mentor a high-performing team of Medical Science Liaisons, medical directors, and HEOR professionals.
Cultivate and manage relationships with key opinion leaders in urology, oncology, primary care, and pathology.
Lead development and dissemination of scientific evidence through publications, congress presentations, advisory boards, and medical education initiatives.
Oversee real-world evidence and health economics and outcomes research to support payer engagement and reimbursement strategy.
Partner with commercial leadership to ensure medical and scientific integrity across promotional materials and launch readiness activities.
Represent Cleveland Diagnostics at scientific conferences, payer meetings, and regulatory interactions.
Drive cross-functional collaboration with Clinical Development, Regulatory Affairs, Market Access, and Commercial teams.
Establish standard operating procedures, compliance frameworks, and medical affairs infrastructure for a scaling organization.

Benefits

100% employer-paid medical insurance for single coverage effective on date of hire; 50% employer-paid medical coverage for spouse/dependents.
100% employer-paid dental and vision coverage for the entire family.
No-cost employee coverage for group term life, short-term disability, and long-term disability.
4% employer retirement contribution match.
Incentive Performance Plan.
Stock Option Program.
Paid Family Leave Program.
Generous PTO plan and holiday program.
Flexible work schedule.
Employee referral program.
Newly built-out office space with convenient access.
Free coffee, snacks, and other goodies.