The position will be based in Princeton, N.J. with occasional travel to CHDI’s other offices in LA and NYC.
Job Reports To
CHDI is a private, not-for-profit research organization. We work with an international network of scientists to discover drugs that slow the progression of Huntington’s disease (HD). We seek to accelerate scientific progress by serving as a collaborative enabler. Our strategy is to encourage researchers to develop practical ideas, useful research materials, and powerful technologies, often by providing financial support. Our activities extend from exploratory biology to the identification and validation of therapeutic targets, and from drug discovery and development to clinical studies and trials.
CHDI has recently set up a broad-based consortium with the Critical Path Institute that will more clearly define regulatory pathways leading to the approval of HD therapeutics. The HD Regulatory Science Consortium (HD-RSC) brings together participants from within and without the HD community to advance drug development tools for regulatory endorsement and to facilitate clinical data standardization and collaboration.
This position will be responsible for planning, coordinating & managing projects aimed at defining regulatory pathways and supporting development and approval of therapeutics for the HD community at large.
The successful candidate will:
- Plan and support large collaborations with partners from academic, biotech/pharma industry, regulators, clinical networks, and patient communities
- Provide medical/scientific input and drive or contribute to the creation of relevant strategies and documents supporting pre-competitive regulatory science
- Be an active member of consortium working groups developing specific drug development tools
- Provide regulatory support for internal studies and programs within CHDI; proactively contribute to ongoing scientific dialog for various Foundation programs
- Support discussions with sponsors regarding regulatory strategies for HD
- Manage collaborative relationships with vendors and other partners to ensure timely execution of projects
- Work independently while leading the project teams and directing the work of team members
- M.D. or Ph.D. degree
- At least 3 years of direct experience in regulatory science or in clinical research with focus on regulatory science and drug development tools; experience from pharma/biotech or academic setting acceptable
- Knowledge of FDA and EMA regulatory pathways for drug approval
- CRO, contract management, and budgetary experience
- Demonstrated knowledge of clinical trial components and support functions
- Knowledge of FDA and ICH regulations regarding Good Clinical Practice (GCP)
- Excellent interpersonal skills, and both written and oral communication skills
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