Director Medical Development, MRD Breast Portfolio

Sr. Principal Medical Development Director, Breast Portfolio

At Exact Sciences, we're helping change how the world prevents, detects, and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Sr. Principal Medical Development Director, Breast Portfolio, will be responsible for clinical and translational leadership in the development and execution of the company's precision oncology strategies; including, but not limited to, the design and implementation of next-generation sequencing (NGS) based assays, focused on the development, validation, and regulatory approval of diagnostic tests designed to help determine the most appropriate therapies for breast cancer patients, monitor therapy effectiveness, and detect the presence of residual disease.

In partnership with the Product and Medical Strategy teams, this role will provide medical leadership during the design, implementation, and reporting of studies that support pipeline products and/or line extensions to on-market products. This position will develop external relationships with oncology leaders at academic institutions, cooperative groups, and research organizations, identifying investigators and sites to inform medical strategies and participate in clinical trials. The Sr. Principal Medical Development Director, Breast Portfolio, will initiate and lead external ad boards involving medical leaders in pharma, key opinion leaders, and other third parties. This position will be responsible for the review, interpretation, and leadership in translation of key study results into evidence-based claims and will help design and implement the medical support for all new or extended precision oncology tests and services with applications to breast cancer patients.

The Sr. Principal Medical Development Director, Breast Portfolio, will be both a leader of and participant on internal cross-functional program teams and working groups including, but not limited to, members of the business development, research and development, pathology and clinical lab operations, biostatistics, clinical affairs, medical affairs, regulatory, market access, and commercial teams. This position will also provide medical leadership across Precision Oncology as a member of the medical organization.

This position can be based in Redwood City, CA, San Diego, CA, or be field based.

Essential Duties

• Develop the overall vision and strategy for one or more specific Precision Oncology (PO) products, including, but not limited to, the Oncotype DX recurrence score; OncoExTra and therapy selection portfolio; the molecular residual disease (MRD) liquid biopsy portfolio, and digital pathology algorithms, as apply to the clinical care of breast cancer patients, in partnership with internal and cross-functional stakeholders including commercial, product, compliance, market access, and regulatory.
• Identify opportunities to expand indications for existing PO products and new products within the biotech/pharma space.
• Collaborate with cross-functional team members from the research and development, product, and commercial organizations to participate in and provide medical expertise to the formulation of commercialization strategy and the creation of 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; including, but not limited to, the adoption and development of novel approaches for the demonstration of clinical validation and utility.
• Engage with medical leaders within medical and surgical and radiation oncology to gain a greater understanding of key clinical questions in patient management, requisite a new generation of clinical tool needs, and facilitate their understanding of the scientific validity and clinical utility of Exact PO products.
• Accountable for scientific presentations and publications generated as a result of PO product development collaborations.
• Provide oncology expertise and clinical insight for cross-functional teams throughout the lifecycle of practice-changing multiomic tests and services.
• Engage with colleagues in the medical organization to drive continuous improvement of team leadership practices including, but not limited to, department communications, interviews of potential new team members, team building initiatives, and enhancement of Precision Oncology's unique culture.
• Create an innovative and proactive approach to identify biopharma partners for new product opportunities and indication expansion of existing products.
• Apply strong analytical skills.
• Apply strong verbal and written communication skills, with the ability to create and maintain open, clear, and collaborative communication with internal stakeholders and senior management, as well as external partners, customers, and key opinion leaders.
• Ability to build and lead internal and external collaborations.
• Ability to integrate and apply feedback in a professional manner.
• Ability to prioritize and drive results with a high emphasis on quality and scientific rigor.
• Ability to excel and work effectively in a cross-functional team environment.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System (QMS) policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to travel up to 30% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• 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.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 2+ years of experience in healthcare.
• Experience in oncology within the pharmaceutical or biotech industry with an emphasis on clinical or translational research.
• Experience working with various drug classes used in the management of breast cancer patients.
• Experience in the development of new oncology therapeutics and molecular diagnostics.
• Strong knowledge of FDA and Ex-U.S. regulatory documentation and processes.