Director Medical Development, MRD Breast Portfolio

About the role

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

The Director Medical Development, MRD Breast Portfolio, will be responsible for clinical and translational leadership in the development and execution of the company’s precision oncology strategies. This includes 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 role will initiate and lead external advisory 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 Director Medical Development, MRD Breast Portfolio will be both a leader of and participant on internal cross-functional program teams and working groups including members of business development, research and development, pathology and clinical lab operations, biostatistics, clinical affairs, medical affairs, regulatory, market access, and commercial teams. This position can be based in Redwood City, CA, San Diego, CA, or be field based.

Responsibilities

• Develop the overall vision and strategy for one or more specific Precision Oncology (PO) products, including the Oncotype DX recurrence score, OncoExTra and therapy selection portfolio, the molecular residual disease (MRD) liquid biopsy portfolio, and digital pathology algorithms, as they apply to the clinical care of breast cancer patients, in partnership with internal and cross-functional stakeholders.
• Identify opportunities to expand indications for existing PO products and new products within the biotech/pharma space.
• Collaborate with cross-functional team members from research and development, product, and commercial organizations to provide medical expertise in the formulation of commercialization strategy and 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 novel approaches for demonstrating clinical validation and utility.
• Engage with medical leaders within medical, surgical, and radiation oncology to understand key clinical questions in patient management 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.
• Drive continuous improvement of team leadership practices, including department communications, interviews, 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, verbal, and written communication skills to maintain collaborative relationships with internal stakeholders, senior management, external partners, customers, and key opinion leaders.
• Build and lead internal and external collaborations, integrating and applying feedback professionally.
• Prioritize and drive results with a high emphasis on quality and scientific rigor.
• Excel in a cross-functional team environment while upholding 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.
• Act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or computer screen and/or perform typing for approximately 90% of a typical working day.
• Travel up to 30% of working time, which may include overnight/weekend travel.

Requirements

• M.D. or 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 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.

Pay

The base pay for this position is $149,300.00 – $298,700.00. In specific locations, the pay range may vary from the range posted.