Summary of Major Responsibilities
Exact Sciences is seeking a Medical Oncologist, with a strong interest in Precision Medicine, to be a member of the Precision Oncology Medical Affairs Organization. In collaboration with other Directors in U.S. Medical Affairs, the Director for Next Generation Sequencing (NGS) / Lung Cancer helps develop and lead the U.S. strategic direction of Medical Affairs education and research for the Paradigm PCDx test, with a primary focus on the Advanced Lung Cancer indication, as well as other metastatic solid tumors. As a physician leader on PCDx Clinical and Commercial Teams, this individual collaborates with other senior leaders in Medical Affairs, Medical Development, Marketing & Sales, Reimbursement & Managed Care, Pathology, Customer Service, and Business Development, Life Cycle Management, and the PCDx Laboratory Director. This leader also provides physician support to Medical Science Liaisons with either full- or part-time responsibilities in supporting the PCDx product.
This is a newly defined physician leadership role is fully dedicated to support the U.S. launch and growth of the Paradigm PCDx test, a Next Generation Sequencing (NGS) and IHC-based panel of markers to guide specific therapies in advanced solid tumors. This individual is responsible for delivering specialty subject matter expertise supporting education and research initiatives in Lung Cancer and other solid tumors. As the medical face of the company, this leader is responsible for developing and executing on a Key Opinion Leader (KOL) Plan in Lung Cancer, including national educators, top investigators, guideline panel members, and key clinical leaders at strategic accounts.
Internally, this leader is accountable for defining medical strategies for the clinical utility of the Paradigm PCDx panel in Lung Cancer and other solid tumors, to achieve inclusions in clinical guidelines and to maximize payer reimbursement. Accordingly, based on feedback from KOLs and payers, this leader is expected to identify clinical data gaps and define opportunities for growth. These clinical data gaps inform the broader Medical Organization strategic plan for post-marketing studies, including company-sponsored collaborative trials, investigator-initiated studies, and health outcomes or economic studies for the PCDx panel.
Additional Core Medical Affairs accountabilities within the assigned therapeutic area(s) include managing medical content of external presentations and medical communications, leadership of advisory boards, medical conference coverage, leadership of clinical content training programs for sales representatives, and medical reviews/approvals of all promotional materials.
This leadership position requires a proven professional with established personal and scientific credibility to interact with national thought leaders and centers of excellence. The position may be field-based, but must commit to a presence in the Redwood City, California office for key internal meetings roughly once every 4-6 weeks.
Essential Duties and Responsibilities
- Define medical strategies; including clinical data gaps and further studies needed to maximize the clinical utility of the PCDx panel in Lung Cancer to achieve inclusions in clinical guidelines and to maximize payer reimbursement.
- Develop and manage strategic plan for engaging top tier KOLs in Lung Cancer; including national speakers and/or educators, guideline panel members, top investigators (to include those with cooperative study groups), and physician leaders of large group practices.
- Provide Medical Affairs support to Commercial and Life Cycle Management strategies for PCDx, particularly in the Lung Cancer indication (and other solid tumors to be determined).
- Support strategic publication planning for PCDx product, particularly in Lung Cancer indication.
- Lead national/regional advisory boards to seek external strategic advice to guide product strategy.
- Manage strategic and operational plans for investigator initiated and collaborative studies for PCDx in Lung Cancer (and other solid tumors to be determined).
- As Medical Monitor for company-sponsored clinical utility studies in Lung Cancer, develop study concepts, protocols, and budgets in collaboration with defined study teams.
- Provide clinical leadership in analyzing and interpreting study results, and in producing abstracts, posters, presentations, and publications in collaboration with study team members.
- Act as primary senior level contact for investigators interested in developing and performing independent or collaborative studies for the PCDx test in Lung Cancer (and other solid tumors to be determined).
- In collaboration with other Medical Affairs leaders, oversee the provision of clinical support through MSL Team, Customer Service, Medical Information, and Pathology Case Review Team in response to inquiries from medical oncologists, surgeons, and pathologists in guiding appropriate PCDx test ordering and interpreting Next-Generation Sequencing (NGS) / Immunohistochemistry (IHC) test results on specific patient cases.
- Provide specialty training on NGS and Lung Cancer to the MSL team and the broader U.S.-based Medical Organization (including Medical Development, Medical Communications, Pathology, and Clinical Operations) as new educational materials, workflows, policies, and initiatives are developed to support PCDx product launch.
- Support medical-marketing planning; including conference planning and support, medical education content development, faculty speaker training, sales training, reimbursement initiatives, and review of promotional and educational materials.
- Provide external clinical presentations at sponsored symposia, and at meetings with oncology groups and payer organizations.
- Support payer dossier submissions and reviews in support of regional and national managed care and reimbursement objectives.
- Provide scientific support for medical educational initiatives; including medical congresses and the development of faculty speakers.
- Assure compliance with relevant corporate and regulatory guidelines.
- Strong business management and leadership skills with strategic thinking capabilities.
- Capable of working well in self-directed manner across multiple cross-functional teams.
- Strong collaboration and active listening skills.
- Excellent oral, written and presentation communication skills.
- 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.
- Regular and reliable attendance.
- Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% of a typical working day
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
- Ability to travel 60% of working time away from work location, may include overnight/weekend travel.
- MD; preferably a Medical Oncologist.
- 3+ years of related industry experience.
- 3+ years of experience in planning and execution of clinical research, including study design, protocol development, managing study operations, interpreting, and presenting results, and manuscript development.
- 3+ years of experience in delivering clinical presentations to oncologists.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
- Possesses an established relationship network of U.S. physician experts in lung cancer.
- Clinical experience and expertise in Advanced Lung Cancer along with clinical experience in working with NGS-based diagnostic gene panels.
- Expertise in lung cancer oncology and Next Generation Sequencing with prior diagnostics, pharmaceuticals and/or biotechnology industry experience.