The Scientific Director, Breast Cancer Portfolio, within the Clinical Development department, will provide scientific and strategic leadership for evidence generation across a portfolio of breast cancer diagnostic products spanning early development, clinical validation, regulatory submission, and post-market management.

This individual will be responsible for developing and executing the evidence strategy supporting both in-development and commercially available assays. The role will lead external scientific collaborations, oversee the successful execution of clinical and translational research programs, and translate emerging evidence into peer-reviewed publications, evidence supporting product claims, and clinically actionable applications.

Working closely with Product, Medical, Biostatistics, AI and Market Access teams, the Scientific Director will identify evidence gaps, prioritize research investments, and ensure that clinical studies generate data that support regulatory, reimbursement, guideline, and clinical objectives.

The ideal candidate will possess deep expertise in breast cancer biology and the contemporary breast cancer treatment landscape, translational oncology, diagnostic test development, and research management.

Essential Responsibilities:

Portfolio Evidence Strategy

Serve as the scientific lead for the breast cancer evidence portfolio by maintaining continuity across studies, coordinating scientific priorities across collaborators and internal stakeholders, and ensuring that research activities remain aligned with long-term portfolio objectives.

Develop and maintain an integrated evidence-generation strategy across all breast cancer products, including both in-development and commercially available assays.

Define evidence requirements necessary to support product development, regulatory submissions, reimbursement, clinical adoption, and guideline inclusion.

Identify opportunities for indication expansion and next-generation product development.

Develop strategic evidence roadmaps that align scientific priorities with product objectives.

Clinical and Translational Research Leadership

Partner with internal and external stakeholders to identify, evaluate, and prioritize clinical datasets that support portfolio evidence-generation objectives.

Provide scientific oversight of retrospective, prospective, observational, and translational studies supporting breast cancer diagnostics.

Develop study concepts, research plans, protocols and study endpoints, working closely with Biostatistics and Medical.

Ensure that clinical studies are designed to answer high-priority scientific and clinical questions.

Provide scientific oversight throughout all phases of study execution, including study initiation, interpretation, and reporting.

Monitor study progress and proactively address scientific, operational, and technical challenges.

External Scientific Collaborations

Establish and maintain relationships with key opinion leaders, academic medical centers, cooperative groups, and research networks.

Identify, evaluate, and prioritize opportunities for research collaborations.

Serve as the primary scientific contact for investigators participating in collaborative studies.

Lead scientific discussions with external collaborators throughout study development and execution.

Research Proposal Development and Evaluation

Author and review research proposals supporting investigator-initiated and company-sponsored studies.

Evaluate external research proposals for scientific merit, feasibility, strategic alignment, and potential clinical impact.

Collaborate with investigators to refine study objectives, endpoints, and analytical approaches.

Ensure alignment between research objectives and broader portfolio evidence strategies.

Scientific Communication and Publication

Develop publication strategies supporting the breast cancer portfolio.

Lead the preparation of abstracts, conference presentations, posters, and peer-reviewed manuscripts.

Translate study findings into scientifically rigorous and clinically meaningful evidence.

Ensure timely dissemination of research findings.

Present scientific data internally and externally 

Cross-Functional Leadership

Partner closely with Product, Medical, Biostatistics, AI and Market Access teams.

Serve as the clinical development representative on cross-functional product teams.

Provide scientific expertise throughout product development and commercialization.

Contribute to the development of product claims, target product profiles, and commercialization strategies.

Success in This Role Will Be Defined By:

Development of a clear, portfolio-level evidence strategy.

Successful execution of high-impact clinical and translational studies.

Expansion of strategic research partnerships.

Timely publication of clinically meaningful research.

Generation of evidence that advances both product development and clinical adoption.

Key Competencies:

Scientific leadership

Evidence-generation strategy

Stakeholder management

Publication planning

Clinical study design

Translational research

Project execution

Written and verbal scientific communication

Scientific influence without authority.

Education and Experience Requirements:

Ph.D., M.D., Pharm.D., or equivalent advanced degree in oncology, cancer biology, pathology, molecular biology, epidemiology, or a related discipline.

Minimum of 5 years of experience in oncology clinical development, translational research, diagnostics, biotechnology, or pharmaceutical development.

Demonstrated expertise in breast cancer biology and clinical management.

Experience developing and executing clinical studies supporting molecular diagnostics, digital pathology, genomic assays, AI-based diagnostics, or companion diagnostics.

Experience leading collaborations with academic investigators and cooperative research groups.

Track record of first-author, senior-author, or collaborative peer-reviewed publications.

Experience authoring study protocols, research proposals, abstracts, and manuscripts.

Strong understanding of clinical trial methodology, observational studies, and translational research.

Experience working in cross-functional environments involving regulatory, product, commercial, and scientific stakeholders.

Excellent communication, presentation, and relationship-building skills, with the ability to engage clinical experts.

Strong strategic thinking and analytical skills.

Comfortable operating independently in a fast-paced, collaborative startup environment with a high degree of ownership.

Passion for improving patient care through AI-driven healthcare innovation.

Expected Travel: Up to 5% domestic and international for scientific collaboration meetings.

Preferred Qualifications:

Experience developing evidence strategies for commercially available diagnostic assays.

Experience supporting regulatory submissions for diagnostic products.

Familiarity with breast cancer prognostic, predictive, and treatment-selection assays.

Experience with real-world data, real-world evidence, and outcomes research.

Knowledge of digital pathology, artificial intelligence, machine learning, or multimodal biomarkers.

Existing relationships with breast cancer investigators, cooperative groups, and academic research networks.