Senior Director, Medical Affairs

Cleveland Diagnostics•Cleveland, OH

1d•Remote

About The Position

Cleveland Diagnostics is a precision diagnostics company focused on early cancer detection and management. Its flagship product, IsoPSA, measures PSA by protein structure to support prostate cancer risk stratification, and the company is advancing a pipeline of structure-based biomarker tests. The Senior Director, Medical Affairs will lead and scale the medical affairs function, serving as a bridge among clinical science, key opinion leaders, payers, and the broader medical community. The role will build the evidence base and clinical credibility needed to support adoption of IsoPSA and pipeline products. It reports to the Chief Medical Officer. The position may be remote, with travel to Cleveland, Ohio for one week per month. The role leads medical affairs strategy and team development, scientific evidence generation and dissemination, real-world evidence and health economics research, payer engagement support, and cross-functional collaboration. It also represents the company at scientific, payer, and regulatory meetings and establishes medical affairs procedures and compliance infrastructure. Cleveland Diagnostics describes its organization as family-focused, friendly, and flexible, and emphasizes employee well-being. The company offers a robust benefits package and is an equal opportunity employer committed to a workplace free from harassment and discrimination. Accommodations are available for applicants with disabilities.

Requirements

MD, PhD, PharmD, or equivalent advanced degree.
At least 10 years of progressive Medical Affairs experience within diagnostics, oncology, or medtech.
Leadership experience.
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 multitask across software communication and data-entry programs while using a telephone for several hours a day; safely drive and travel using available mass or air transit; and climb stairs if the elevator is unavailable.
The position may require involvement outside standard business hours.

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.
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.

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 generation of 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 appropriate 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 and short- and long-term disability.
4% retirement contribution employer match.
Incentive Performance Plan and Stock Option Program.
Paid Family Leave Program.
Generous PTO and holiday program.
Flexible work schedule.
Employee referral program.
Newly built-out office space.
Free coffee, snacks, and other goodies throughout the day.