Head of Clinical Science & Strategy — Precision Oncology

Waiv, formerly Owkin Dx; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Waiv, formerly Owkin Dx, seeks a Director of Clinical & Scientific Strategy — Precision Oncology to lead the medical backbone of an AI-based breast cancer SaMD. You will own the medical strategy, drive clinical evidence generation, and engage KOLs across NA and Europe.

You will translate data into medical communications, assess trends, and collaborate with RAQA, Product, and Clinical Affairs to support regulatory submissions and product lifecycle decisions.

Qualifications

• Advanced degree required (MD, PharmD, or PhD) in oncology, pathology, translational medicine, or similar.
• Deep expertise in breast cancer biology, clinical practice, and treatment decision-making.
• Strong command of prognostic and predictive biomarker methodology.
• Comfort with quantitative oncology data analysis and interpretation (biostatistics, survival analysis, biomarker validation, data interpretation).

Responsibilities

• Own the end-to-end medical strategy for the breast cancer AI-based prognostic solution, from evidence generation through clinical adoption.
• Drive the scientific narrative: translate clinical data into compelling medical communications.
• Evaluate emerging scientific trends, competitive intelligence, and standards of care to inform product positioning and lifecycle management.
• Contribute to product strategy regarding claims development and regulatory submissions with RAQA, Product, and Clinical Affairs.

Skills

KOL engagement

Publication experience

Advisory boards

Biostatistics

Survival analysis

Biomarker validation

Data interpretation

Scientific communication

Education

MD/PhD/PharmD in biomedical field

Job description

We are looking for a Director, Clinical & Scientific Strategy — Precision Oncology to serve as the scientific and clinical backbone of one of our flagship AI-based SaMD (Software as a Medical Device) product lines in the breast cancer space. This is a lifecycle role spanning evidence generation, KOL engagement, and clinical deployment support.

This person will be the primary interface between Waiv’s internal Medical team and the external scientific community (oncologists, pathologists, guidelines committees, academic centres), playing a critical role in establishing the scientific credibility and clinical adoption of our tools.

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 — in coordination with the VP of Medical Affairs
• Drive the scientific narrative: translate clinical data into compelling, rigorous medical communications for internal and external audiences
• Evaluate emerging scientific trends, competitive intelligence, and evolving standards of care to inform product positioning, portfolio prioritisation, and lifecycle management
• Contribute to product strategy regarding claims development and regulatory submissions in partnership with RAQA, Product, and Clinical Affairs

2. Clinical Evidence Generation

• Co-develop and review study protocols 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
• Support identification and prioritisation of data cuts for major oncology congresses
• Support evidence generation for market access strategy and build data packages for payers

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 — including cooperative groups, academic institutions, and healthcare systems — for clinical validation interventional trials; co-develop investigator-initiated research frameworks
• Gather and synthesise field-based medical insights; systematically feed clinical intelligence back into Product, Portfolio, and R&D strategy

4. Cross-functional Collaboration

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

Scientific & Clinical Background

• 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, and treatment decision-making
• Strong command of prognostic and predictive biomarker methodology
• Comfort with quantitative oncology data analysis and interpretation: biostatistics, survival analysis, biomarker validation methodology, and data interpretation

Medical Affairs & Industry Experience

• Minimum 8–10 years of Medical Affairs, MSL, or clinical/scientific leadership experience in oncology, ideally in a 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/EMA guidance) is strongly preferred

Operational & Cross-cultural Skills

• Self-starter with high autonomy; comfortable in a lean, fast-paced environment typical of a growth-stage medtech company
• Excellent scientific communication skills — written (publications, regulatory documents, slide decks) and verbal (advisory boards, congresses)
• Willingness to travel internationally; estimated travel expected for congresses, KOL meetings, and site visits across North America and Europe