Senior Director, Medical Affairs

Our team is growing, and we currently have an immediate opening for a
Senior Director, Medical Affairs

Cleveland Diagnostics is a precision diagnostics company dedicated to transforming the early detection and management of cancer. Our flagship product, IsoPSA, represents a paradigm shift in prostate cancer risk stratification — measuring PSA by protein structure rather than concentration alone to provide physicians with a more clinically meaningful signal. We are advancing a pipeline of structure-based biomarker tests with the potential to redefine the early detection and management of disease.

We are seeking a strategic, scientifically credible, and commercially minded Senior Director of Medical Affairs to lead and scale our medical affairs function at a pivotal stage of growth. Reporting to the Chief Medical Officer, this executive will serve as the primary bridge between clinical science, key opinion leaders, payers, and the broader medical community — building the evidence base and clinical credibility that will drive adoption of IsoPSA and our pipeline products.

Title: Senior Director, Medical Affairs

Location: Remote ok, but 1 week/month travel to Cleveland, Ohio

Reports to: Chief Medical Officer

The Senior Director, Medical Affairs will serve as the primary bridge between clinical science, key opinion leaders, payers, and the broader medical community — building the evidence base and clinical credibility that will drive adoption of IsoPSA and our pipeline products.

• 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 (MSLs), medical directors, and HEOR professionals
• Cultivate and manage relationships with Key Opinion Leaders (KOLs) in urology, oncology, primary care, and pathology
• Lead the development and dissemination of scientific evidence through publications, congress presentations, advisory boards, and medical education initiatives
• Oversee the generation of real-world evidence (RWE) and health economics and outcomes research (HEOR) 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 appropriate for a scaling organization

• MD, PhD, PharmD, or equivalent advanced degree required; clinical training in urology, oncology, or internal medicine strongly preferred
• 10+ years of progressive experience in Medical Affairs within diagnostics, oncology, or medtech; leadership experience required
• Deep understanding of the prostate cancer diagnostic landscape, including PSA-based testing, liquid biopsy, and guideline-driven care pathways, is highly desirable
• Proven track record in building and leading MSL teams and engaging KOLs at a national or global level
• Strong scientific communication skills — ability to translate complex data for diverse audiences, including clinicians, payers, and patients
• Entrepreneurial mindset with the ability to operate effectively in a lean, high-growth environment
• Working knowledge of OIG guidelines, PhRMA Code, and medical affairs compliance requirements

Ability to: sit, stand and/or…