Job Purpose Summary: The Executive Director (ED) is responsible for the overall strategic planning, management and activities of collaborative research endeavors with various stakeholders to accomplish objectives of the Transplant Therapeutics Consortium. The ED will coordinate initiative projects, provide operational excellence, financial oversight, and project implementation management. The ED communicates the vision of the consortium to key stakeholders, including pharma, academic, and government participants; existing and potential funders; strategic partners and the scientific community through talks and scientific publications.
Essential Job Duties and Responsibilities:
Provide overall leadership, and administrative and scientific oversight of the Initiative's activities.
Provide scientific input to workgroup discussions dealing with clinical and scientific issues relating to the work of the consortium including data sharing, model informed drug-development, biomarker and clinical outcome assessments (COA) as appropriate.
Foster relationships with key individuals among regulatory bodies, consortium members, other research initiatives or other collaborative efforts in the field.
Guide the execution of a detailed work plan and its milestones to develop, evaluate, and prepare applications for submission to the FDA/EMA for qualification of quantitative disease models, biomarkers, COAs, etc. for a specific use in drug development as appropriate.
Establish and lead working group qualification projects (where appropriate), including developing research plans, task lists, milestones and timelines.
Recruit and qualify new organizations from pharmaceutical, biotechnology and device companies for potential membership in the consortium; enlist other research-performing organizations that are doing work in the area to benefit from their expertise and data.
Create and execute detailed research work plans and revise as appropriate to meet changing needs and requirements.
Prepare annual budget and manage expenditures.
Collaborate across consortia on lessons learned.
Lead working group teleconferences and coordinating committee meetings to ensure progress towards scientific and strategic objectives.
Identify and contract with expert consultants, as necessary, to provide scientific input into projects.
Work with C-Path administration management to provide financial oversight of any grants or funds utilized to execute the work of the Initiative.
Direct project manager(s) for the working groups to provide project implementation/management/oversight/tracking of all collaborative efforts.
Communicate the consortium's progress via scientific publications and presentations.
Seek collaborations/connectivity with other organizations in the same space.
Provide input to strategic development planning and actively contribute to leadership activities at C-Path.
Travel on occasion for out-of-town meetings (approximately 5-10%).
Other duties and responsibilities may be assigned.
Supervise project manager(s), and administrative support staff.
Oversee vendors and consultant relationships
Education and Training:
A PhD (or equivalent doctoral degree) in Pharmacology, Biology or related scientific discipline.
Seven to ten years' experience in drug development (drug discovery, mechanistic pharmacology, safety assessment, clinical development, project management or regulatory affairs in the pharmaceutical industry and/or FDA/EMA).
Broad scientific, clinical, technical and regulatory understanding of the functions involved in the development of pharmaceutical products.
Experience with the design, conduct, and reporting of experiments or studies relevant to the preparation of IND applications: for example, the applications of novel efficacy or safety biomarkers, or preclinical efficacy models.
Working knowledge of assay development and validation, and biostatistical analysis.
Working knowledge of regulatory approval and the drug development process.
Demonstrated aptitude for leading and managing complex teams and deliverables.
Ability to facilitate the scientific activities of diverse groups of stakeholders toward improving the conduct of regulated drug studies.
Ability to provide vision, find incentives and common ground, and give clear and concise messaging to consortium of scientists with multiple demands for their time and attention.
Knowledge of FDA/EMA/PMDA regulations and requirements.
Working knowledge of good clinical practices.
Strategic planning and leadership skills.
Apply effective management, interpersonal, negotiation, and problem-solving skills.
Expertise in managing productivity of complex collaborations and teams.
Adapt to shifting priorities, demands, and timelines.
Track best practices and lessons learned and operationalize those within the team.
Identify opportunities for improvement and make constructive suggestions for change.
Practice highest level of integrity and core value system consistent with C-Path's code of conduct.
Ability to meet target deadlines and manage time effectively.
Demonstrate negotiation skills.
Prior experience in evaluating milestones and the context of information being provided by vendors/providers.
Experience managing a team of researchers.
Exercise sound business judgment when making decisions and adhere to external and internal policies and regulations.
Strong critical thinking and analytical skills.
Ability to successfully anticipate issues or challenges and proactively address without being specifically directed.
Use sound judgment when working with critical or confidential information.
Internal Number: 201901
About Critical Path Institute
Critical Path Institute (C-Path) is a nonprofit, public-private partnership with the Food and Drug Administration (FDA) created under the auspices of the FDA’s Critical Path Initiative program in 2005.
C-Path’s aim is to accelerate the pace and reduce the costs of medical product development through the creation of new data standards, measurement standards, and methods standards that aid in the scientific evaluation of the efficacy and safety of new therapies.
These pre-competitive standards and approaches have been termed “drug development tools” (DDTs) by the FDA, which established a process for official review and confirmation of their validity for a given context of use.
C-Path orchestrates the development of DDTs through an innovative, collaborative approach to the sharing of data and expertise. We build consensus among participating scientists from industry and academia with FDA participation and iterative feedback. The process culminates in a formal application to FDA for official “qualification” of the DDT for a given use in product development. Qualified DDTs then become open standards for the scientific community which, in turn, may be assured both of the scienti...fic rigor under which they were developed and of the FDA’s understanding and acceptance of their validity.