Medical Advisor / MSL Director USA

We are looking for a senior Medical Advisor / MSL Director to serve as the scientific and clinical backbone of one of our flagship AI-based SaMD product lines in the breast cancer space. This is a lifecycle role - spanning evidence generation, KOL engagement, clinical deployment, and regulatory support - with a dual geographic footprint: a US base with hands-on responsibility for EU-facing activities and a supporting remit for US-based medical insights related to a complementary solution and portfolio

1. Product Lifecycle - Medical Leadership

• Own the end-to-end medical strategy for the assigned breast cancer AI-based prognostic solution, from evidence generation through clinical adoption

• Drive the scientific narrative: translate clinical data into compelling, rigorous medical communications for internal and external audiences

• Monitor competitive landscape and clinical guidelines in early breast cancer; identify and communicate implications for product positioning

• Contribute to claims development, and regulatory submissions in partnership with RAQA and Product and Clinical affairs
  
  

2. Clinical Evidence Generation

• Co-develop and review study protocols, statistical analysis plans, and clinical study reports for prospective and retrospective validation studies

• Contribute medical perspective to abstract and manuscript preparation; coordinate author relationships and publication planning

• Interface with internal  teams and external partners to ensure medical accuracy of analytical outputs
  
  

3. KOL Engagement & Scientific Exchange

• Build and maintain high-value relationships with breast oncologists, pathologists,and surgeons across North America and Europe

• Serve as the scientific face of Waiv at key congresses and symposia; deliver medical education and facilitate advisory boards

• Identify clinical champions and research collaborators; co-develop investigator-initiated research frameworks

• Gather and synthesize field-based medical insights; systematically feed clinical intelligence back into Product, Portfolio and R&D strategy

• Support HTA-adjacent discussions and country-level evidence requirements in collaboration with Market Access
  
  

4. US Medical Insights — Secondary Product

• Cover US-based medical insights and KOL engagement activities for a complementary AI-based breast cancer prescreening tool

• Identify US-specific clinical practice patterns, unmet needs, and evidence gaps relevant to prescreening and genetic testing workflows

• Relay field intelligence to the core Medical Affairs and Product team for integration into strategy and evidence planning
  
  

5. Cross-functional Collaboration

• Collaborate closely with: Medical Affairs team, Commercial team, VP Pathology, Market Access, and R&D/Biostatistics, Marketing

• Contribute to board-level and investor-facing scientific communications as required

• Support Medical Affairs team capacity and knowledge-sharing on breast cancer science and medical device regulatory context

• Advanced degree required: MD, PharmD, or PhD in a relevant biomedical discipline (oncology, pathology, translational medicine, or similar)

• Deep expertise in breast cancer biology, clinical practice

• Strong command of prognostic and predictive biomarker methodology

• Comfort with quantitative oncology data: biostatistics, survival analysis, biomarker validation methodology

• Minimum 8–10 years of Medical Affairs, MSL, or clinical/scientific leadership experience in oncology, ideally in a software-driven diagnostic or precision medicine context

• Demonstrated experience managing or co-developing clinical evidence programs (observational studies, registries, prospective studies)

• Hands-on KOL engagement and publication experience; ability to lead advisory boards and represent the company at international congresses

• Familiarity with precision medicine, genomic testing regulatory and clinical frameworks (FDA guidance) is strongly preferred

• Ability to operate effectively across US and EU stakeholder environments; prior experience managing international collaborations

• Self-starter with high autonomy; comfortable in a lean, fast-paced environment typical of a growth-stage company

• Excellent scientific communication skills -  written (publications, regulatory documents, slide decks) and verbal (advisory boards, congresse)

• Fluency in English required; French or another language is  a meaningful advantage but not mandatory
  
  

• Please attach a CV.

• Waiv is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, gender, sexual orientation, age, color, religion, national origin, protected veteran status or on the basis of disability.

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