Company Description

JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers in chapters across the United States and our six international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information please visit jdrf.org or follow us on Twitter @JDRF.

As a JDRF team member, you can look forward to interesting and challenging work, building strong relationships with fellow staff and our network of volunteers, and having a meaningful impact on the lives of everyone affected by this devastating disease. JDRF supports a diverse and inclusive workforce and is an Equal Opportunity Employer.

Job Description

The Clinical Project Manager (Clinical Scientist) is a position within the JDRF Research Department focused on driving JDRF's Research Strategy to accelerate translation of research advances to clinical testing of potential transformative treatments and cures for type 1 diabetes (T1D). The Clinical Project Manager (“Manager”) will work in a matrixed team that includes scientists, grant administrators, and partnership and alliance management colleagues to conduct due diligence of potential new T1D clinical studies and trials, as well as manage JDRF’s existing portfolio of clinical studies and trials. Internally and externally, the Manager will be a key contact on all matters related to JDRF’s clinical studies, and serve as a liaison to facilitate collaborations among stakeholders.

This role requires experience and in-depth knowledge of clinical trial design and clinical operations, including familiarity with ICH and GCP guidelines and regulatory requirements for human studies. Past experience and demonstrated capabilities with management of multi-site and multi-national trials is required. The successful candidate will possess strong interpersonal and communication skills, and have the ability to facilitate and influence complex collaborations with multiple stakeholders.

RESPONSIBILITIES:

• Project management of clinical studies and trials from study conception through final CSR and publication. 
  • Collaborate with colleagues in JDRF Research to conduct due diligence on new clinical study proposals; work with external study investigators to communicate recommendations (for example from external peer review).
  • Lead oversight and manage progress on JDRF’s portfolio of active clinical studies and trials, implementing mitigation plans where necessary.
  • Utilize knowledge of all phases of clinical trial development from study concept through final CSR; clinical operations and efficiencies, and compliance with regulatory processes and ethical approvals.
• Serve as a clinical research liaison to internal and external stakeholders
  • Work with JDRF’s staff and research community to encourage development of innovative trial designs and encourage efficiencies in design of proof-of-principle and proof-of-concept studies. JDRF’s studies include interventional studies with devices and/or novel or repurposed drugs/biologics for all stages of T1D.
  • Serve as a liaison during peer review of proposals to receive external input from key stakeholders and opinion leaders to optimize study design and operational execution.
  • Partner with JDRF Research colleagues to develop projects to execute according to the team’s desired outcomes, within required timelines and budget allocations.
  • Consult JDRF’s policy team to address issues around regulatory compliance of JDRF’s portfolio; ensure JDRF’s policies, terms and conditions adhere to federal regulations; identify and troubleshoot non-compliance cases in real time.
  • Work with JDRF’s program administration, research operations and management teams to ensure internal data on clinical studies and trials is accurate and updated in a timely fashion.
• Serve as an internal and external resource on clinical operations, employing tactics to generate logistical efficiencies
  • Assess budgets for appropriateness to research scope and operations, and meet JDRF budget allocations and processes. Negotiate budgets as needed.
  • Work with stakeholders to construct project milestones and timelines, revising and creating mitigation plans where necessary.
  • Work with administrative team to ensure timely processes and payments.
  • Promote operational efficiencies to drive clinical studies and trials to completion, creating maximum value for the T1D research and patient communities.

Qualifications

• 5 years of clinical trial management experience at a CRO, pharmaceutical company, health-related consulting company, or biomedical/clinical experience within academia (a combination of the above, or equivalent experience, will be considered).
• Demonstrated technical competence and experience in design, implementation, tracking and completion of global clinical trials to commercialization with highest standards of quality and GCP. Track record of delivering trials on time and within budget.
• Ability to engage in discourse on innovative drug development from early through to late-stage development, knowledge of regulatory requirements and competitive landscape.
• Proven organizational and project management skills.
• Knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results. Facility with negotiating budgets and timelines to serve evolving scientific/project needs.
• Superior analytical and problem-solving skills, and time management/organizational skills.
• Facility in interfacing with all levels of personnel, volunteers, and outside organizations, via written and oral communication.
• Experience in coordinating and chairing meetings and facilitating discussions toward actionable items (e.g., clinical site coordinating meetings, DSMB, etc.)
• Effective interpersonal and communication skills with ability to foster collaborations, create alignments and influence without formal authority. Proven ability to work in cross-functional and matrixed teams and deliver results.
• Scientific and/or medical knowledge of diabetes is a plus.
• Hybrid in-person presence at JDRF’s New York City offices.

EDUCATION: 

• Master’s degree, Ph.D., Pharm.D., R.N. or equivalent

Additional Information

Target Salary: $95-$120K

Resumes without cover letters will not be considered

To protect the health and safety of our employees, all employees are required to be fully vaccinated for COVID-19 and have a COVID-19 booster shot regardless of location or position. This includes those with remote status. Requests for medical, religious, and other exemptions will be considered on an individual basis. JDRF will comply with all federal, state, and local laws.

JDRF supports a diverse and inclusive workforce and is an Equal Opportunity Employer. 
All information will be kept confidential according to EEO guidelines.

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