Sr. Principal Medical Development Director

📋 Description

• • Own the end-to-end clinical vision for Exact Sciences’ flagship Precision Oncology portfolio—spanning Oncotype DX recurrence, radiation, and colon recurrence scores, OncoExTra therapy-selection assays, and our cutting-edge molecular residual disease (MRD) liquid-biopsy tests—translating genomic insight into real-world treatment decisions that extend and improve patients’ lives.
• • Architect and execute global clinical strategies that secure regulatory approval and payer coverage for next-generation sequencing (NGS)–based diagnostics, ensuring every study design, protocol, and data package meets or exceeds FDA, EMA, and ex-U.S. health-authority standards while accelerating time-to-market.
• • Serve as the medical monitor and scientific conscience on cross-functional program teams, guiding biostatisticians, R&D scientists, pathology and clinical-lab operations, regulatory, market-access, and commercial partners through complex development milestones, risk assessments, and evidence-generation plans.
• • Identify and cultivate relationships with world-renowned academic oncologists, cooperative trial groups, and research consortia to secure high-impact clinical-trial sites, co-develop innovative study concepts, and translate emerging science into actionable product enhancements.
• • Lead external advisory boards, steering committees, and scientific symposia with pharma partners, KOLs, and patient-advocacy groups to shape therapeutic-area strategy, uncover unmet clinical needs, and position Exact Sciences as the thought leader in precision cancer care.
• • Translate real-world evidence and post-market surveillance data into compelling scientific narratives—authoring peer-reviewed publications, podium presentations, and regulatory dossiers that demonstrate clinical utility and differentiate our assays in competitive markets.
• • Drive indication-expansion initiatives by scanning the oncology landscape for new biomarkers, emerging drug classes (e.g., checkpoint inhibitors, ADCs), and companion-diagnostic opportunities; negotiate and co-design collaborative studies that extend product lifecycles and open new revenue streams.
• • Champion a culture of continuous improvement within the Medical organization—mentoring junior medical scientists, refining interview processes, launching team-building initiatives, and embedding diversity, equity, and inclusion principles into every aspect of our work.
• • Translate complex genomic and clinical data into clear, actionable insights for senior executives, commercial teams, and external stakeholders, ensuring alignment on product positioning, launch sequencing, and lifecycle investment priorities.
• • Uphold Exact Sciences’ mission and values by modeling accountability, scientific integrity, and quality in every experiment, interaction, and decision; comply fully with the Quality Management System and global regulatory requirements.
• • Travel up to 30% (including overnight and weekend trips) to attend investigator meetings, scientific congresses, regulatory interactions, and internal leadership summits—bringing back critical intelligence to refine strategies and strengthen partnerships.