Senior Director, Translational Science
- San Diego, CA
Job Description Summary:
Leads and directs research related to the translation of pre-clinical assets of the mood disease area stronghold (Mood DAS) and the Glutamate Pathway Area stronghold (Glutamate PAS) to the clinic with special focus on biomarkers and diagnostics. Interfaces with the Experimental Medicine groups in La Jolla, USA, and Beerse, Belgium to critically review, revise and implement clinical protocols with a special emphasis on primary, secondary endpoint and exploratory biomarkers. Oversees the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations as they relate to neuroscience biomarkers. Sets the biomarker strategy for the Mood DAS and the Glutamate PAS, including oversight and direction of all biomarker efforts. Manage the biomarker operations team.
- Interface with the Experimental Medicine groups in La Jolla, USA, and Beerse, Belgium to critically review, revise and implement clinical protocols with a special emphasis on primary, secondary endpoint and exploratory biomarkers.
- Set the biomarker strategy for the mood disease area stronghold (Mood DAS) and the Glutamate Pathway Area stronghold (Glutamate PAS), including oversight and direction of all biomarker efforts.
- Responsible for managing the biomarker operations team with three FTE.
- In addition, responsible for the development and integration of the biomarker strategy with the overall clinical development plan for a portfolio of compounds; oversee the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations as they relate to neuroscience biomarkers.
- Translational Science: Interface with the La Jolla and Beerse Experimental Medicine groups; discuss clinical protocols from a biomarkers perspective and critically revise clinical protocols in order to embed biomarkers in clinical protocols for first in man studies.
- Biomarker Lead for Mood DAS and Glutamate PAS: (1) Accountable for all mood DAS biomarker needs in support of all compounds in Discovery, Experimental Medicine, and Clinical Development. Develop biomarker strategy and lead biomarker efforts for all mood DAS compounds, and provide input for project prioritization within the mood DAS. (2) Accountable for all Glutamate PAS related biomarker efforts. (3) Interface with internal and external experts in relevant biomarker platforms to contribute to the development of a multimodal biomarker strategy for the Mood DAS and the Glutamate PAS. Work with the leaders of the mood DAS and Glutamate PAS, as well as the respective clinical teams, to ensure complete alignment with the overall DAS/PAS goals. (4) Remain current on the evolving landscape of biomarker technologies and applications, study methodologies, assessment tools and relevant drug mechanisms of action.
- Supervise the Biomarker Operations Teams to facilitate implementation and to manage the overall neuroscience biomarker budget.
- Interact with investigational sites, clinical consultants, Contract Research Organizations (CRO) and other vendors as necessary. Monitor adherence to protocols and assess study completion.
- Supervise data analysis and interpretation and communicate results to internal and external stakeholders.
- Form collaborations with academic, industrial consortia, and commercial partners to optimize support of neuroscience biomarkers.
Required Years of Related Experience:
Education: MD or PhD. 12+ years of progressive experience in life sciences or medicine, including eight to ten (10+) years of experience in the biopharmaceutical industry or related experience including previous supervisory or leadership roles. Neuroscience therapeutic area education, training, and experience. Internationally recognized track record of scientific contributions in this field with first author publications in high impact journals.
Required Knowledge, Skills and Abilities:
- Demonstrated and internationally recognized scientific contribution in the neuroscience therapeutic area
- Good knowledge of Good Clinical Practices and regulatory requirements; good knowledge of the concepts of clinical research and drug development, especially with respect to first in man studies (translational science).
- Proven ability to provide scientific expertise to preclinical research and clinical development programs
- Experience in evaluating strategies for clinical development and to critically evaluate outside expert advice
- Demonstrable team leadership/management experience
- Demonstrated ability to interpret biomarker data in context of phenotype data.
- Proven ability to work in a team environment and to lead projects with minimal supervision.
United States-California-San Diego-
Janssen Research & Development, LLC (6084)
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