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Vice President Medical Development and Pharma Strategy

Apply Share Job ID 1426 Category Research & Development Job Location Redwood City, California Posted Date 02/22/2020


Genomic Health, a subsidiary of Exact Sciences is seeking an extraordinary Medical Oncologist with a strong background in precision medicine to be the leader of Oncology Medical Development and Pharma Strategy within the Genomic Health Medical Organization. As the pioneer and leader in high-value oncology diagnostics, Genomic Health has a strong track record of developing and commercializing innovative genomic tests through its central California-based reference laboratory to optimize the treatment of oncology and urology cancer patients. Based on its success, Genomic Health is quickly broadening its business model to accelerate growth through new tests, including localized testing solutions, which address the multiple needs of Pharma to help guide and monitor therapies for cancer patients.

The Senior Medical Director / Vice President - Medical Development and Pharma Strategy, reporting to Chief Medical Officer, will be responsible for providing clinical leadership during the development and execution of the company's oncology strategies and will be a key leader in the design and implementation of oncology pharma-collaborations focused on the development, validation and regulatory approval of diagnostic tests designed to help determine most appropriate therapies for patients, monitor therapy effectiveness, and detect the presence of residual disease.

In partnership with Product Lifecycle Management, this role will: 1) provide oncology leadership during the design, development and implementation of strategic initiatives that advance GHI's objective to accelerate the development of new products and services through partnerships with pharma organizations; 2) provide oncology expertise during development, validation, and regulatory approval of companion in vitro diagnostics; 3) develop external relationships with leaders in academic oncology, cooperative trial groups, and research organizations; 4) identify investigators and sites to participate in clinical trials; 5) initiate and lead external collaborations involving medical leaders in pharma, key opinion leaders, and other third parties; 6) review, interpret and lead the reporting of key results; and 7) Work closely with other members of the Medical Leadership Organization to continue building the Medical Development Organization responsible for all Oncology and Urology Product Development;

The candidate will be both a leader of and participant on internal cross-functional program teams and working groups including members of the assay development, pathology, biostatistics, clinical operations, medical affairs, and commercial teams. He/She will also provide overall medical leadership across Genomic Health as a member of the Medical Organization.


· Identify opportunities to expand indications for existing Genomic Health products within the pharma space and opportunities for new products.
· Responsible for the development of an overall Pharma strategy, including regulatory strategy in partnership with internal / cross-functional stakeholders such as Product Lifecycle Management.
· Collaborate with team members from the Research and Development, Product Lifecycle Management and Commercial organizations to participate in the formulation of commercialization strategy and the creation of product profiles for new products and line extensions of existing products of interest to Pharma.
· Work closely with the Business Development and Product Lifecycle organizations to identify and evaluate externally-sourced opportunities for new products.
· Lead clinical activities for the pharma program including management of pharma relationships, external medical relationships and collaborations required for assay proof-of-concept studies, development studies and clinical validation studies.
· Lead the development of pharma-related clinical protocols required to support product development, validation, and/or commercialization including the adoption and/or development of novel approaches for demonstrating clinical validation and utility.
· Engage with medical leaders with vision in oncology to gain a greater understanding of key clinical questions in oncology diagnostics and management and to facilitate their understanding of the scientific validity and clinical utility of GHI products.
· Assume accountability for scientific presentations and publications generated as a result of product development collaboration.
· Provide oncology expertise and clinical insight for cross-functional teams at Genomic Health throughout the lifecycle of practice-changing genomic tests and services.
· Active participant in the functional management of the Medical Development Organization
· Engage with colleagues in the Medical Organization team to drive continuous improvement of team leadership practices including department communications, interviewing potential new team members, teambuilding and enhancement of GHI's unique culture.
· MD/PhD or MD with specialty training in Oncology is preferred
· More than 10 years of experience in healthcare preferred.
· At least 5 years of pharmaceutical or biotech industry experience in Oncology is required with an emphasis on clinical/translational research and the development of new therapeutics and/or molecular diagnostics.
· Deep domain knowledge of the oncology therapeutic landscape required. Very strong existing network of key opinion leaders and pharma executive contacts is highly preferred.
· FDA and ex-US regulatory knowledge and experience required.
· Experience leading cross-functional internal and external teams of professionals focused on complex, multi-faceted projects.
· Strong analytical skills and familiarity with laboratory analytical process development and biostatistics.
· Demonstrated ability to build and lead internal and external collaborations.
· Capable of innovative and proactive approaches which will result in identifying pharma partners for new product opportunities and indication expansion of existing products.
· Strong communicator with the ability to create and maintain open, clear, and collaborative communication with internal stakeholders including senior management, external partners and customers, and key opinion leaders.
· Able to integrate and apply feedback in a professional manner.
· Able to prioritize and drive to results with a high emphasis on quality.
· Ability to excel and work effectively in a cross-functional team environment.


We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!