Genomic Health, Inc. (GHI) is seeking an exceptional clinical investigator in urologic oncology with a strong interest in personalized medicine to provide clinical leadership in the development of tests and services that will transform cancer patient care. The Director/Sr. Director of Urologic Oncology Development will be responsible for providing clinical leadership of development programs resulting in the successful and timely launch of new products and services and line extensions for marketed products. Genomic Health is building upon the success of the Oncotype DX breast cancer assay with a growing number of programs, including those in prostate, bladder and kidney that are developing tissue- and liquid-based assays in order to drive precision oncology. Specifically, following the successful launch of the Oncotype DX Genomic Prostate Score, Genomic Health is creating a portfolio of products and services to bring precision medicine into the practice of Urology.
To support these programs, the Director/Sr. Director will be responsible for clinical vision and oversight during the investigation, development, and commercial stages of new and existing products including the design and execution of clinical validation and utility studies. Clinical study leadership includes initiating and managing external collaborations with leaders in urologic oncology, cooperative groups, and research organizations, identifying investigators to participate in key clinical trials, and reviewing, interpreting, and presenting key results. The Director/Sr. Director of Urologic Oncology will also provide clinical support for due diligence in relevant business development activities.
The successful candidate will be a key member of the multi-functional Core Team including leaders from Research and Development, Product Lifecycle Management, Laboratory Operations, and the Commercial Organization and a leader in urologic oncology across Genomic Health. This role is also expected to significantly contribute to the Oncology Development organization by contributing to the development of strategies for generating clinical validation and utility data. The Director/Sr. Director for Oncology Development will report to the Chief Medical Officer.
- Lead the clinical activities for development programs in Urologic Oncology including the clear definition of the clinical indication for our products and the development and the execution of the clinical development portions of the Integrated Program Plan (IPP).
- Create and/or manage the development of clinical protocols required to support product development, clinical validation, and clinical utility with a focus on creating efficient, generalizable approaches that build a robust portfolio of trials supporting test adoption and reimbursement.
- Develop external collaborations required for assay development, proof-of-concept studies and clinical validation and utility studies.
- Lead scientific presentations and publications generated as a result of product development collaborations.
- Engage with thought leaders in urologic oncology to gain a greater understanding of key clinical questions in urologic cancers and to facilitate their understanding of the scientific validity and clinical utility of genomic-data in treatment decisions, and specifically how GHI products are differentiated
- Identify opportunities to expand indications for marketed and in-development products
- Responsible for providing clinical perspective and reviewing language for reports and promotional materials
- Participate in creation of product profiles for new products and line extensions
- Provide strategic and tactical advice to product core teams and subteams, Research and Development, Business Development and Commercial at GHI and to executives for development of Oncology science and business at GHI
- Engage with leadership team colleagues on the CMO staff for continuous improvement of team leadership practices including department communication methods, capability needs and hiring, teambuilding and enhancement of GHI's unique culture
- Other duties as assigned
- MD/PhD or MD required with specialty training in Urology and/or Urologic Oncology preferred
- At least 10+ years' experience in healthcare preferred with at least 5 years' experience in Urology or Urologic Oncology with emphasis on clinical/translational research and the development of new therapeutics and/or molecular diagnostics
- Experience developing healthcare products in industry is preferred
- Strong analytical and writing skills with a publication track record
- Experience leading a team of professionals focused on complex, multi-faceted projects
- Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed
- Demonstrated ability to build and manage internal and external collaborations
- Capable of innovative and proactive approaches to solving unmet medical needs which will result in identifying new product opportunities and expansion of existing products
- 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 work well in a cross-functional team structure
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Travel Requirements: 20-30% Travel
- Standing or sitting for long periods of time may be necessary
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation