Senior Director, Medical Affairs

Senior Director, Medical Affairs

Cleveland Diagnostics is a precision diagnostics company dedicated to transforming the early detection and management of cancer. We are advancing a pipeline of structure-based biomarker tests with the potential to redefine the early detection and management of disease.

The Opportunity: 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.

Essential Duties and 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 (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

Qualifications/Requirements:

• 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
• Experience supporting payer evidence strategies, including HEOR and value dossier development
• 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

Physical Requirements/Working Conditions/Equipment Used:

Ability to: sit, stand and/or walk throughout course of day; operate a computer and multitask across many software communication and data entry programs while operating and communicating through telephone device for several hours a day; ability to safely drive a vehicle and travel using appropriate and available mass and/or air transit. This position may require involvement outside of standard business hours. Offices reachable by elevator but should be able to climb stairs in case elevator out.

Cleveland Diagnostics offers an extremely robust benefits package which includes:

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
• 4% retirement contribution Employer match
• Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
• Paid Family Leave Program
• Generous PTO plan & holiday program
• Flexible work schedule & lucrative employee referral program
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built-out office space
• Free coffee, snacks and other goodies all day long

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law.

Cleveland Diagnostics, Inc.