Sr. Principal Medical Development Director

Exact Sciences•San Diego, CA

51d

About The Position

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. The Sr. Principal Medical Development Director will be responsible for clinical and translational leadership in the development and execution of the company's 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 patients, monitor therapy effectiveness, and detect the presence of residual disease. In partnership with Portfolio Lifecycle Management and Strategy, this role will provide oncology leadership during the design, development, and implementation of studies that support pipeline products and/or line extensions to on-market products. This position will develop external relationships with leaders in academic oncology, cooperative trial groups, and research organizations, as well as identify investigators and sites to participate in clinical trials and inform medical strategies. The Sr. Principal Medical Development Director 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 the report of key study results and will also help design and implement the medical support for all new or extended precision oncology tests and services. The Sr. Principal Medical Development Director 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, or be field based.

Requirements

M.D. or D.O.
Completion of fellowship training in 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.
Legal authorization to work in the country of employment without current or future sponsorship.

Nice To Haves

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 checkpoint inhibitor therapies.
Experience in the development of new oncology therapeutics and molecular diagnostics.
Strong knowledge of FDA and Ex-U.S. regulatory documentation and processes.

Responsibilities

Develop the overall vision and strategy for one or more specific Exact Sciences' Precision Oncology (PO) products, including, but not limited to, the Oncotype DX recurrence score, radiation score, and colon recurrence score; OncoExTra and therapy selection portfolio; and the molecular residual disease (MRD) liquid biopsy portfolio, in partnership with internal and cross-functional stakeholders including commercial, pipeline, compliance, and regulatory.
Identify opportunities to expand indications for existing Exact Sciences' PO products and new products within the pharma space.
Collaborate with Exact Sciences' cross-functional team members from the research and development, pipeline, 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 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 precision and molecular, 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 at Exact Sciences throughout the lifecycle of practice-changing genomic 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, interview potential new team members, team building initiatives, and enhancement of Precision Oncology's unique culture.
Create an innovative and proactive approach to identify pharma partners for new product opportunities and indication expansion of existing products.
Apply strong analytical skills.
Apply strong communication skills; ability to create and maintain open, clear, and collaborative communication with internal stakeholders, senior management, external partners and 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.
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 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.

Benefits

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage.

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