The position will be based in Princeton, N.J. with occasional travel to New York City and Los Angeles.
Job Reports To
This position will report to a Vice President/Unit Leader and will be responsible for planning, coordinating & managing clinical studies in HD aimed at developing and validating clinical scales and performing clinimetric research.
CHDI is a privately-funded, not-for-profit biomedical research organization devoted to a single disease – Huntington’s disease. Our mission is to develop drugs that will slow the progression of Huntington’s disease (HD) and provide meaningful clinical benefit to patients. CHDI is a “science first” organization; our foremost consideration is to do the best science as quickly and efficiently as possible.
CHDI’s Clinical Team oversees a portfolio of projects aimed at understanding the natural progression of HD disease, developing the best biomarkers and outcome measures for use in clinical trials, finding ways to expedite and improve the execution of clinical trials, paving relevant regulatory pathways, and working with external partners to support their clinical development plans. The team engages a diverse array of partners to help manage this portfolio, including academic institutions, government agencies, contract research organizations (CROs), biotech and pharmaceutical companies.
We are seeking a highly motivated and organized individual to assist CHDI Science Directors managing projects in the clinical portfolio (including, but not limited to clinical studies and trials). This detail-oriented, self-starting individual will work closely with internal colleagues (scientific, legal and financial) and external collaborators (physicians, academic institutions, CROs, and biotech and pharmaceutical companies) on all aspects of CHDI’s clinical research and development efforts.
A Clinical Program Manager will be expected to work closely with project Science Directors and others within CHDI to:
- plan clinical projects
- develop and review project descriptions, project budgets and associated contracts (e.g., funding, CROs, etc.) to assure compliance with Foundation policies
- develop and/or oversee development of other project-related documents including protocols, case report forms, study manuals, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed
- evaluate and select CROs, contractors and other outside vendors
- anticipate areas of risk, and plan and implement solutions to mitigate these risks
- assure good communication among the project team which is made up of members from within the organization and outside vendors/collaborators
- track and report on progress of clinical projects to the extended project team and management as appropriate
- reconcile budgets and authorize payments
- proactively identify problem issues and facilitate discussion of potential solutions that can be implemented by the project team
- maintain strong relationships with key stakeholders and partners in collaborative efforts (universities, government agencies, not-for-profit organizations, pharma/biotech companies)
The successful candidate will:
- have a Bachelors or Master’s degree in life sciences, healthcare, project management/business, or related field
- have at least 5 years of pharmaceutical industry/biotech/CRO/academic experience in clinical research project/trial management including budgeting, contracting and study execution
- be a proactive, creative problem solver and open to innovative solutions
- be detail-oriented and care about the quality of her or his work
- have demonstrated the ability to work independently in a distributed, interdisciplinary, team-oriented environment
- be proficient in the following Microsoft applications: Excel, PowerPoint, and Word
- be comfortable in a fast-paced, dynamic environment
An ideal candidate might also have:
- knowledge of, and experience applying Good Clinical Practice (GCP) and ICH Guidelines
- advanced skills using Excel to develop tracking and budget/invoicing spreadsheets; proficiency in MS Project
- experience working on CNS clinical research or drug development
- experience with regulatory agencies
- experience negotiating vendor agreements
Send CV’s to firstname.lastname@example.org