Medical Science Liaison (MSL)
Posted 3 weeks ago
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Serve as a key scientific and clinical expert for Cleveland Diagnostics' IsoPSA product, driving appropriate clinical utilization and scientific understanding through engagement with Key Opinion Leaders and evidence generation. This role supports product lifecycle planning, clinical strategy, and accurate scientific communication for an In Vitro Diagnostic (IVD) assay for prostate cancer risk stratification.
Responsibilities
- Establish and maintain relationships with national and regional KOLs, investigators, and clinical societies (e.g., Urology, Oncology) to ensure deep understanding of IsoPSA.
- Serve as the primary scientific resource for external stakeholders, conducting fair-balanced, evidence-based scientific exchange on IsoPSA data and mechanism.
- Gather and relay clinical insights and unmet needs from the field back to internal teams (R&D, Commercial, Regulatory Affairs, Clinical Operations).
- Support clinical research initiatives under Clinical Operations by serving as primary contact for investigator-initiated studies (IIS).
- Support the design and execution of Health Economics and Outcomes Research (HEOR) studies to demonstrate real-world value of IsoPSA.
- Develop and deliver training on scientific data and clinical use of IsoPSA for various internal teams.
- Lead the development and review of Medical Information content to address unsolicited scientific inquiries from Healthcare Professionals (HCPs).
- Provide medical review and approval for promotional and non-promotional materials to ensure regulatory and compliance adherence.
- Contribute scientific insights to Market Access/Reimbursement strategies.
- Work closely with Regulatory and Quality Assurance teams to support ongoing regulatory filings and adherence to IVD regulations.
Requirements
- Advanced clinical or scientific degree (MD, PharmD, RN, PhD) in a life science discipline related to oncology
- Minimum of 5 years of experience in a Medical Affairs, Clinical Affairs, or Medical Science Liaison role within IVD, Diagnostics, or Pharmaceutical industry
- Strong understanding of regulatory guidelines (FDA, CLIA, CAP, HIPAA), clinical research regulations/GCP, biostatistics, and standards for scientific exchange
- Proficiency in Microsoft Office Suite
- Excellent written and verbal communication skills
- Strong attention to detail
- Works well in a collaborative & team-oriented environment; good interpersonal skills
- Ability to manage & prioritize workload effectively
Qualifications
- Advanced clinical or scientific degree (MD, PharmD, RN, PhD) in a life science discipline related to oncology (e.g., Oncology Diagnostics)
- 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
Nice to Have
- Specific experience in Urologic Oncology, liquid biopsy, or biomarker-based diagnostics
Skills
* Required skills
Benefits
About Cleveland Diagnostics
Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer.