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.
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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
Qualifications:
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:
20%-30%
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)
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