The position will be based in Princeton, N.J. with occasional travel to New York City and Los Angeles.
This position will report to a Vice President/Unit Leader and will be responsible for “wet” (biochemical) biomarkers research with an emphasis on unbiased (‘omics) biomarkers in the clinical context of HD. This will include the planning and supervision of sample-based biomarker projects and coordinating & managing experimental and observational clinical studies in HD, in particular studies involving translational biomarker discovery and validation.
The successful candidate will:
- Provide critical input in the design and supervision of translational biomarker studies, mostly based on ‘omics technologies,
- Be able to independently design, plan and manage large single-/multi-site HD clinical studies (and related teams) through CRO’s and academic/industrial collaborators in a time-bound manner.
- Be able to provide critical input to data collection/analysis and quality control methods deployed in such studies.
- Be responsible to provide scientific input and to drive the creation of clinical documents required for the implementation, monitoring and evaluation of such clinical and translational studies.
- Review work produced by project team(s) and ensure that studies are completed on time and within budget.
- Partner with Clinical Program Manager(s), internal legal and finance functions and external collaborators to identify and resolve contracting, and fiscal issues related to HD clinical research in a timely manner.
- Manage fiscal performance of the studies and maintain close control of study costs.
- Proactively contribute to ongoing scientific dialog for various Foundation programs.
- M.D. or Ph.D. degree in a biomedical area.
- At least 5 years of direct experience in clinical research in pharma/biotech or academic settings with focus on translational research in clinical settings, using ‘omics technologies.
- Good understanding of analysis principles for complex large data sets is a preference factor.
- Demonstrated knowledge of clinical study components and support functions.
- Knowledge of FDA and ICH regulations regarding Good Clinical Practice (GCP).
- Demonstrated record of self-motivation and problem-solving skills.
- CRO, contract management, and budgetary experience for clinical projects.
- Team oriented, excellent interpersonal skills, good written and oral communication skills.