Director, Medical Development, Precision Oncology, MD

Position Overview

The Medical Development Director, MD will be responsible for clinical and translational leadership in the development and execution of the company's oncology strategies, including 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.

Essential Duties Include, but are not limited to, the following:

• Develop the overall vision and strategy for one or more specific Precision Oncology (PO) products, including 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 PO products and new products within the pharma space.
• Collaborate with cross-functional team members from research and development, pipeline, and commercial organizations to 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 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 and facilitate their understanding of the scientific validity and clinical utility of 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 genomic tests and services.
• Engage with colleagues in the medical organization to drive continuous improvement of team leadership practices including department communications, interviewing potential new team members, team building initiatives, and enhancement of Precision Oncology's culture.
• Create an innovative and proactive approach to identify pharma partners for new product opportunities and indication expansion of existing products.
• Initiate and lead external ad boards involving medical leaders in pharma, key opinion leaders, and other third parties.

Minimum Qualifications

• M.D., D.O., in a related field as outlined in the essential duties.
• Completion of fellowship training or equivalent 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.
• 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 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.