Director, Oncology DevelopmentApply Job ID 2016-4668 Category Medical Job Location Redwood City, CA Posted Date 03/07/2017
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, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer, one of the greatest issues in healthcare today. With its Oncotype IQ™ Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 600,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
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 value our employees and consider them an integral part of our company’s growth and success. We maintain competitive total rewards programs designed to satisfy our employees’ work life and personal life needs.
To learn more about careers at Genomic Health visit: http://www.genomichealth.com/join_our_team
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.
About Information Technology
Our Information Technology (IT) team designs, deploys, and supports state-of-the-art systems solutions that enable every aspect of Genomic Health’s operations. We value a systematic, data-driven approach to understanding and meeting business needs in a cost-effective and timely manner. The team has a wide variety of responsibilities, including Infrastructure Services, DevOps, Enterprise Architecture, Software Engineering, Quality Engineering, Enterprise Business Applications, Support Services, and Security. As a member of this dynamic and collaborative team, you'll work to help architect, configure, and integrate cloud solutions, data warehouse and analytics frameworks, and next generation sequencing applications that have revolutionized the application of genomics to the development of advanced cancer diagnostic tools. Our IT team rewards innovation and development, and prides itself on always looking into the future of technology – all to facilitate the development and distribution of our Oncotype DX® genomic tests for personalizing cancer treatment decisions.
If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!