Medical Science Liaison (MSL)

Medical Science Liaison (MSL)

The Medical Affairs Professional serves as a key scientific and clinical expert for Cleveland Diagnostics flagship IsoPSA product, a Class III In Vitro Diagnostic (IVD) assay for prostate cancer risk stratification. This role is responsible for driving the appropriate clinical utilization and scientific understanding of IsoPSA by engaging with Key Opinion Leaders (KOLs), generating real-world evidence, and ensuring accurate, compliant scientific communication across the organization and to the external medical community.

Essential Duties and Responsibilities

1. Scientific Exchange and Key Opinion Leader (KOL) Management

• Establish and maintain relationships with national and regional KOLs, investigators, and clinical societies (e.g., Urology, Oncology) to ensure a deep understanding of the scientific and clinical value of IsoPSA.
• Serve as the primary scientific resource for external stakeholders, conducting fair-balanced, evidence-based scientific exchange on IsoPSA data, mechanism of action (IsoClear - Solvent Interaction Analysis (SIA) platform and methodology), and its role in the prostate cancer diagnostic pathway.
• Gather and relay clinical insights and unmet needs from the field back to internal teams (e.g., R&D, Commercial, Regulatory Affairs, Clinical Operations) to inform product lifecycle planning, clinical strategy, and educational content.

2. Evidence Generation and Research Support

• Support clinical research initiatives under the supervision of the Clinical Operations team by serving as a primary contact to investigators for investigator-initiated studies (IIS), facilitating internal review of IIS proposals for feasibility and conduct, identifying potential sites/investigators for sponsored trials, and assisting in site communications during active sponsored trials
• Support the design and execution of Health Economics and Outcomes Research (HEOR) studies to demonstrate the real-world value, clinical utility, and payer-access benefits of IsoPSA.
• Contribute to the development of clinical abstracts, posters, and manuscripts for presentation at national and international medical conferences and publication in peer-reviewed journals.

3. Medical Education and Communication

• Develop and deliver training on the scientific data and clinical use of IsoPSA for the Commercial, Market Access, Research & Development, and Clinical Operations teams.
• Lead the development and review of Medical Information content (e.g., standard response letters, FAQs) to address unsolicited scientific inquiries from Healthcare Professionals (HCPs).
• Provide medical review and approval for promotional and non-promotional materials developed by Marketing/Commercial teams to ensure strict regulatory and compliance adherence (e.g., FDA guidance for IVDs) in collaboration with Regulatory Affairs and Corporate Compliance.
• Note all Medical Education and Communication materials must be fair-balanced and non-promotional scientific exchange.

4. Strategic and Regulatory Support

• Contributes scientific insights to Market Access/Reimbursement strategies, especially regarding coverage policies (e.g., Medicare, Medicaid, VA, and commercial payers) and the appropriate interpretation of clinical utility data.
• Work closely with Regulatory and Quality Assurance teams to support ongoing regulatory filings, post-market surveillance, and adherence to IVD regulations (e.g., FDA, ISO 13485, EU IVDR).
• Participate in Advisory Councils with clinical experts to validate strategic assumptions and gather input on future product development pipeline applications of the IsoClear platform.

Qualifications/Requirements

• Advanced clinical or scientific degree (MD, PharmD, RN, PhD) in a life science discipline related to oncology (e.g., Oncology Diagnostics) is required.
• Minimum of 5 years of experience in a Medical Affairs, Clinical Affairs, or Medical Science Liaison role within the In Vitro Diagnostics (IVD), Diagnostics, or Pharmaceutical industry.
• Specific experience in Urologic Oncology, liquid biopsy, or biomarker-based diagnostics is highly preferred.
• Strong understanding of regulatory guidelines (FDA, CLIA, CAP, HIPAA), clinical research regulations/GCP, biostatistics, and standards for scientific exchange required.
• Proficiency in Microsoft Office Suite
• Excellent written and verbal communication skills
• Strong attention to detail
• Effective written & verbal communication skills
• Works well in a collaborative & team-oriented environment; good interpersonal skills
• Ability to manage & prioritize workload effectively

Core Competencies

• Scientific Acumen: Ability to critically review, interpret, and communicate complex clinical study, basic science, and biostatistics data, especially related to protein structure analysis and proteomic/genomic cancer biomarkers.
• Compliance: Deep understanding of the legal and regulatory landscape governing medical communications and scientific exchange for IVD and IVDR products in the US (and internationally).
• Communication: Exceptional verbal, written, and presentation skills, with the ability to tailor technical content to diverse audiences (from scientists to commercial teams).
• Travel: Ability to travel domestically and occasionally internationally (estimated 50-70%) for conferences, KOL meetings, and internal meetings.

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, Inc.