Sr. Principal Medical Development Director, Breast Portfolio

About the role

The Sr. Principal Medical Development Director, Breast Portfolio, will lead the development and execution of the company's precision oncology strategies, focusing on next-generation sequencing (NGS) based assays for breast cancer patients. This role involves designing and implementing clinical and translational studies, developing external relationships with oncology leaders, and providing medical leadership across Precision Oncology.

Responsibilities

• Develop the overall vision and strategy for Precision Oncology (PO) products, including Oncotype DX recurrence score, OncoExTra and therapy selection portfolio, molecular residual disease (MRD) liquid biopsy portfolio, and digital pathology algorithms.
• Identify opportunities to expand indications for existing PO products and new products within the biotech/pharma space.
• Collaborate with cross-functional team members from research and development, product, and commercial organizations to formulate commercialization strategy and create product profiles for new products and services.
• Participate as the medical monitor on study teams and lead the development and implementation of clinical protocols required to support product development, validation, and commercialization.
• Engage with medical leaders within medical and surgical and radiation oncology to gain insights into key clinical questions, requisite clinical tool needs, and the scientific validity and clinical utility of Exact PO products.
• Provide oncology expertise and clinical insight for cross-functional teams throughout the lifecycle of practice-changing multiomic tests and services.
• Create an innovative and proactive approach to identify biopharma partners for new product opportunities and indication expansion of existing products.
• Apply strong analytical skills, verbal and written communication skills, and the ability to build and lead internal and external collaborations.
• Prioritize and drive results with a high emphasis on quality and scientific rigor.
• Support and comply with the company’s Quality Management System (QMS) policies and procedures.

Requirements

• M.D., D.O., in a related field as outlined in the essential duties.
• Completion of fellowship training or equivalent in medical oncology.
• Demonstrated expertise in molecular oncology.
• Demonstrated ability to lead cross-functional internal and external teams of professionals focused on complex, multi-faceted projects.
• Familiarity with laboratory analytical process development and biostatistics.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.

Qualifications

• Authorization to work in the United States without sponsorship.

Skills

• Strong knowledge of FDA and Ex-U.S. regulatory documentation and processes.

Benefits

Exact Sciences offers a comprehensive benefits package including paid time off, paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits such as medical, prescription drug, dental, and vision coverage. The company is committed to fostering a diverse and inclusive workplace and provides equal employment opportunities for all qualified individuals.