Sr. Director, Clinical Development (Urology)Apply Job ID 2017-5017 Category Medical Job Location Redwood City, CA Posted Date 10/21/2017
Genomic Health, Inc. (GHI) is seeking an exceptional clinical investigator in Prostate/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 (Prostate) 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 (Prostate) 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 (Prostate) 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:
- Use of computer, and or telephone for long periods of time may be necessary.
- Considerable periods of time may be spent concentrating and or analyzing data
- Considerable periods of time may be spent communicating verbally and in various written forms including presentation material and email with other people
- At times, stress may be experienced.
- Standing or sitting for long periods of time may be necessary
- Some lifting (greater than 25 pounds) may be necessary; Facilities, Materials and Engineering employees occasionally must lift at least 50-75 pounds.
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation (GENERALLY LABORATORY & CUSTOMER SERVICE EMPLOYEES ONLY)
Genomic Health is a global provider of genomic-based diagnostic tests that address the overtreatment of cancer, one of the greatest issues in healthcare today. Our goal is to improve the lives of people with cancer by providing personalized, biological information that helps them get the right treatment at the right time, and to avoid unnecessary treatments and their side effects. In this way, our work is truly life, changing.
- Our Oncotype IQ Genomic Intelligence Platform is a portfolio of diagnostic tests that help physicians and patients answer specific and critical treatment questions throughout the cancer journey
- We currently offer Oncotype tests addressing breast, colon, prostate and lung cancers and hundreds of thousands of patients from over 90 countries have benefited from our tests.
- The Oncotype DX breast cancer test is considered standard of care in the US and is included in all major international clinical guidelines for breast cancer treatment.
- We are expanding our portfolio of tests to include additional liquid- and tissue-based tests through clinical research and internal product development as well as strategic partnerships.
Join the Genomic Health Team, and have the unique opportunity to make a difference in the lives of patients with cancer, while developing your career potential. We embrace our unique culture characterized by our Core Values of Community, Truth Seeking, Being Ahead of the Curve and Winning to be the best in the world at what we do. We maintain competitive total rewards programs designed to satisfy our employees’ work life and personal life needs.
All qualified applicants will receive consideration for employment without regard to race, sex, gender identity, color, religion, national origin, protected veteran status, or on the basis of disability.
If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!