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
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.
Employer will assist with relocation costs.
About C-Path (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.