Oncology Development, Associate Director/Director

Genomic Health, Inc. is seeking a medical oncologist with a strong interest in the cutting-edge field of personalized medicine to join our growing Oncology Development group. The Director/Associate Director in Oncology Development will be responsible for providing clinical leadership of Development Programs, resulting in the successful and timely launch of new products and line extensions for marketed products. Genomic Health is building upon the success of the Oncotype DX breast cancer assay with a number of Development Programs, including programs in breast, colon, prostate, lung, and renal cancer. To support these programs, the Director/Associate Director will be expected to initiate and manage external collaborations involving leaders in academic oncology, cooperative groups, advocacy groups, and the biopharmaceutical industry. The successful candidate will also act as an oncology resource within Genomic Health, advising teams including Research, Development, Commercial Operations, Biostatistics and Marketing. The Director/Associate Director will assume a position as clinical lead for a Development Program. Clinical responsibilities for this position will span the development process from gene identification studies in clinical samples through clinical validation to product commercialization. The Director/Associate Director will also be accountable for additional clinical studies to develop line extensions for existing products. It is expected that a successful candidate in this position will assume a growing leadership role in Oncology Development, including mentoring and developing future hires in the group.   Specific responsibilities - Direct the clinical development activities for Development Programs including management of external collaborations required for gene discovery, clinical validation and follow on clinical support studies. - Create and manage clinical protocols required to support product development, validation and commercialization. - Facilitate activities to ensure that the new GHI products meet necessary regulatory requirements - Create and manage clinical protocols required for product line extension activities - Assume accountability for scientific presentations and publications generated as a result of product development collaborations. - Participate in the formulation of commercialization strategy - Engage with thought leaders in oncology to gain a greater understanding of key clinical questions in oncology and to facilitate their understanding of the scientific validity and clinical utility of GHI products - Identify opportunities to expand indications for marketed and in-development products - Facilitate external reimbursement for GHI products through discussion with and education of Insurance Executives and Insurance Medical Director - Participate in creation of product profiles for new products and line extensions - Provide strategic and tactical advice to the Development team at GHI and to the Executive Team for development of Oncology science and business at GHI - MD/PhD or MD with specialty training in Oncology - 1-2 years experience in Oncology with emphasis on clinical/translational research, development of new therapeutics, and/or diagnostics - Strong analytical skills and familiarity with laboratory analytical process development and biostatistics - Superior interpersonal and communication skills - Ability to work well in a cross-functional team structure - Demonstrated ability to build and manage internal and external collaborations - Capable of innovative and proactive approaches which will result in identifying new product opportunities and expansion of existing products If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=499483-3-383 Reference Code: 1276 View all "Genomic Health" jobs