Overview

Senior Director, Medical Affairs Our team is growing, and we currently have an immediate opening for a Senior Director, Medical Affairs About Cleveland Diagnostics 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. 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. Title: Senior Director, Medical Affairs Location: Remote ok, but 1 week/month travel to Cleveland, Ohio Reports to: Chief Medical Officer Job Description: 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. 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 communicati