• 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.

• 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.

• 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.

• 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, 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.

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
• 4% retirement contribution Employer match
• Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
• Paid Family Leave Program
• Generous PTO plan & holiday 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