Senior Director, Medical Affairs

Cleveland Diagnostics; Cleveland (OH); Hybrid; USD 125,000 - 225,000; Full time

Benefits offered by this job

100% Employer-paid medical for single

4% retirement contribution Employer: 4

Paid Family Leave Program

Flexible work arrangements

Job summary

Cleveland Diagnostics, Inc. is seeking a Senior Director of Medical Affairs to lead and scale our medical affairs function.

This executive will bridge clinical science with payers and the broader medical community, driving evidence generation and clinical credibility for IsoPSA and pipeline products. Reporting to the Chief Medical Officer, you will design global strategy, mentor a high-performing team of MSLs and HEOR professionals, and partner with commercial leadership to ensure medical

Qualifications

• MD/PhD or equivalent advanced degree is required.
• 10+ years of Medical Affairs experience in diagnostics, oncology, or medtech with leadership experience.
• Strong scientific communication skills for diverse audiences including clinicians, payers, and patients.
• Proven track record building/leading MSL teams and engaging KOLs at national/global levels.
• Entrepreneurial mindset for lean, high-growth environments.
• Knowledge of OIG guidelines, PhRMA Code, and medical affairs compliance requirements.

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 MSLs, medical directors, and HEOR professionals.
• Cultivate and manage relationships with KOLs 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 HEOR to support payer engagement and reimbursement strategy.
• Partner with commercial leadership to ensure medical/scientific integrity across materials and launches.
• 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.

Education

MD/PhD/PharmD or equivalent

Job description

Our team is growing, and we currently have an immediate opening for aSenior 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
• 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.

We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

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
• No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
• 4% retirement contribution Employer match
• Paid Family Leave 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. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

Pay Range: $125,000 - $225,000 per year