Associate Translational Medicine Director
Associate Translational Medicine Director
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
Provide translational science strategy and support for early and/or late stage clinical trials. Incorporate translational endpoints in clinical trials, interpret data and incorporate results in clinical study reports, regulatory documents and publications. Must have experience in oncology, molecular biology and knowledge of clinical drug development. Experience in immune biology and pathology/histology is required.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Act as the Translational Medicine representative for project teams
• Contribute to the clinical biomarker strategies for company sponsored clinical trials
• Responsible for development and implementation of biomarker (pharmacodynamic, pharmacogenomic and histology based) assays into company sponsored clinical trials
• Participate in clinical protocol and informed consent writing/review of translational medicine components of company sponsored clinical trials. Responsible for responding queries regarding biomarker samples.
• Responsible for tracking and managing biomarker samples by working with sample management staff
• Responsible for biomarker data acquisition, accuracy, quality control, transfers
• Manage the vendors and CROs to achieve translational medicine goals
• Analyze results from translational medicine studies and communicate to the project teams and management as appropriate
• May engage in pre-clinical studies to be conducted in-house or with external collaborators and/or CROs, including analysis and interpretation of results
• Provide support for internal company customers (i.e., Non-Clinical and Clinical Development) for project specific areas
• Expand knowledge of the research and development efforts from relevant academic institutions, competitor pharmaceutical companies, and fee-for-service bioanalytical companies.
• PhD in related discipline or equivalent education and 6+ years of related experience, or;
• Equivalent combination of education/training and experience.
• A minimum of 8 years of experience in the biotechnology or pharmaceutical industry or the equivalent combination of education and industry experience.
• Experience participating in clinical oncology studies with molecular targeted or immunological therapies.
• Excellent communication skills orally or in writing
• Experience in providing presentations of scientific overviews and data in appropriate context for various types of meetings (internal and external)
• Embrace opportunities to learn and adapt to various processes that may be situation specific
• Ability to work independently and cooperatively with translational medicine team
• For sponsored clinical studies
o Expertise in histology based diagnostic assays (Immunohistochemistry, Immunofluorescent monoplex/multiplex, digital pathology), including assay development, data analysis, and clinical application is required
o Experience in spatial expression by advanced omic technologies (e.g. NanoString GeoMx DSP, 10X Visium, Fluidigm Mass cytometry) is a plus
o Ability to integrate principles of Good Clinical Practice and Good Laboratory Practice into clinical trial design
o Understanding of informed consent process in clinical trials as it applies to sample collection for translational medicine studies
o Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results
o Understanding of successful completion of translational projects and preparation of project related publications
o Has good understanding and application of technical principles, theories, concepts and techniques related to immunological processes
o Has good general knowledge of other related disciplines.
o Applies strong analytical and communication skills.
o Good public speaking and presentation skills.
• Has an in-depth knowledge of the functional area.
• Coordinates with cross functional groups in project development areas.
• Exercises independent judgment in methods, techniques and data interpretation.