Associate Director, Clinical Research
JDRF International

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 five international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information, please visit www.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.

The Associate Director, Clinical Research is a critical position within JDRF Research, collaborating with a matrixed team to drive JDRF's goal of bringing therapies and treatments to people with type 1 diabetes (T1D). The director's portfolio will be focused, but not limited to, oversight of JDRF's significant portfolio of clinical studies and trials. The director will play a key role in participating in the due diligence of new opportunities.

This individual will have a robust understanding of clinical trial design, clinical development, clinical operations, drug development, ICH and GCP guidelines, and regulatory requirements in the US and globally. They will have experience managing clinical studies from inception to publication, including multi-site and international interventional trials.

This individual will be highly adaptable and able to work independently while ensuring a consistent degree of collaboration and transparency. Working within the larger JDRF Research team composed of staff scientists, program management, program administration and operations, they will be required to synthesize viewpoints from different angles and problem solve with the overall goal of accelerating high-quality research. They will report to the AVP, Research.

SPECIFIC RESPONSIBILITIES:

• Collaborate with JDRF staff scientists in the due diligence of new funding opportunities. Ensure that project plans are aligned with appropriate ethical and regulatory needs. Assess feasibility of operational plans to achieve study goals in a timely fashion.
• Participate in business development of new clinical opportunities in line with JDRF strategy, including liaising with clinical team members in industry.
• Explore new approaches, including innovative clinical trial design, to enable research questions to be addressed robustly and as efficiently as possible. Explore opportunities to generate clinical data that could impact clinical care guidelines.
• Collaborate with JDRF staff scientists and external clinicians to manage a portfolio of >65 clinical trials, plus observational clinical studies. Ensure that projects are progressing on time and according to project milestones. Engage investigators in developing mitigation plans as needed.
• Oversee the appropriate design of JDRF grants funding clinical work, including the assessment of budgets and the construction of milestones and payment plans.
• Serve as an internal and external resource on matters related to clinical data and research biosample collection.
• Collaborate with JDRF operations and grant administration to ensure funding is aligned with JDRF processes, terms and conditions.
• Communicate ideas in a persuasive, diplomatic and appropriate manner; present funding opportunities and developments in the portfolio to executive management, board members, volunteers and the T1D community.
• Manage and resolve issues, risks, and conflicts internally and externally in a diplomatic and timely manner through excellent listening skills and the ability to ask the right questions.

EXPERIENCE & REQUIREMENTS:

• 4+ years of direct experience in clinical trial management within the pharmaceutical industry, CRO, health-related consulting company, or biomedical/clinical experience within academia.
• Graduate degree (e.g., Ph.D., M.D., Pharm.D., R.N. or R.D) combined with appropriate work experience in a scientific research environment, industry and/or a not-for-profit organization. The combination of education and relevant work 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 and the ability to deliver trials on time and within budget.
• Demonstrated knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
• Demonstrated exceptional communication and organizational/time management skills, and ability to collaborate, align and manage diverse, global cross-functional matrix teams.
• Proven ability to work in cross-functional and cross regional lean/"virtual' outsourced teams and deliver results.
• Strong collaboration, communication and interpersonal skills with the ability to successfully influence internal and external stakeholders, including outside development partners. Proven ability to work in a cross-functional and highly matrixed team with a track record of delivering results.
• Ability to engage in discourse on innovative drug development from early through to late-stage development, knowledge of regulatory requirements and competitive landscape.
• Strong oral and written communication and interpersonal skills with facility in interacting across a wide array of relationships with diplomacy and tact.
• Experience with diabetes an asset
• Hybrid presence in New York City office required.
• Cover letter required in the application.

Target Salary - $125k - $150k

Essential Functions:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools or controls. The employee is occasionally required to stand, walk, sit, reach with hands and arms, climb or balance, and stoop, kneel, crouch or crawl.

The employee must occasionally lift and/or move up to 25 pounds, and infrequently up to 50 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus.

The noise level in the work environment is usually moderate.

Additional information:

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.
JDRF is an Equal Opportunity Employer.
All your information will be kept confidential according to EEO guidelines.

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