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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.
Job Responsibility:
Develop the overall vision and strategy for one or more specific Exact Sciences’ Precision Oncology (PO) products
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 to participate in and provide medical expertise to the formulation of commercialization strategy and the creation of product profiles
Participate as the medical monitor on study teams and lead the development of clinical protocols required to support product development, validation, and commercialization
Engage with medical leaders within precision and molecular, medical and surgical and radiation oncology
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
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 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
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 have:
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
What we offer:
Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage