Scientific Director, Breast Cancer Portfolio

Portfolio Evidence Strategy

• Lead the breast cancer evidence portfolio across in-development and commercially available diagnostic assays.
• Develop integrated evidence-generation strategies and roadmaps.
• Define evidence requirements for product development, regulatory submissions, reimbursement, clinical adoption, and guideline inclusion.
• Identify opportunities for indication expansion and next-generation product development.

Clinical and Translational Research Leadership

• Identify, evaluate, and prioritize clinical datasets supporting evidence-generation objectives.
• Provide scientific oversight of retrospective, prospective, observational, and translational studies supporting breast cancer diagnostics.
• Develop study concepts, research plans, protocols, and endpoints with Biostatistics and Medical teams.
• Oversee study execution from initiation through interpretation and reporting.
• Monitor progress and address scientific, operational, and technical challenges.

External Scientific Collaborations

• Build relationships with key opinion leaders, academic medical centers, cooperative groups, and research networks.
• Evaluate and prioritize research collaboration opportunities.
• Serve as the primary scientific contact for investigators and lead scientific discussions throughout collaborative studies.

Research Proposal Development and Evaluation

• Author and review proposals for investigator-initiated and company-sponsored studies.
• Evaluate proposals for scientific merit, feasibility, strategic alignment, and clinical impact.
• Collaborate with investigators to refine study objectives, endpoints, and analytical approaches.

Scientific Communication and Publication

• Develop publication strategies for the breast cancer portfolio.
• Lead abstracts, conference presentations, posters, and peer-reviewed manuscripts.
• Translate findings into rigorous, clinically meaningful evidence.
• Present scientific data internally and externally.

Cross-Functional Leadership

• Partner with Product, Medical, Biostatistics, AI, and Market Access teams.
• Represent Clinical Development on cross-functional product teams.
• Contribute to product claims, target product profiles, and commercialization strategies.

Key Competencies

• Scientific leadership
• Evidence-generation strategy
• Stakeholder management
• Publication planning
• Clinical study design
• Translational research
• Project execution
• Scientific communication and influence without authority

Requirements

• Ph.D., M.D., Pharm.D., or equivalent advanced degree in oncology, cancer biology, pathology, molecular biology, epidemiology, or a related discipline.
• At least 5 years of experience in oncology clinical development, translational research, diagnostics, biotechnology, or pharmaceutical development.
• Expertise in breast cancer biology and clinical management.
• Experience developing and executing clinical studies involving 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 cross-functionally with regulatory, product, commercial, and scientific stakeholders.
• Excellent communication, presentation, and relationship-building skills.
• Strong strategic thinking and analytical skills.
• Ability to operate independently in a fast-paced, collaborative startup environment.
• Passion for improving patient care through AI-driven healthcare innovation.
• Expected travel of up to 5% domestically and internationally 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.