Job Purpose Summary: The Director of Pediatric Programs will oversee the overall strategic planning and management of collaborative research endeavors with various stakeholders to accomplish the objectives of C-Path's pediatric consortia and programs. The Director will also serve as the Executive Director (ED) of the International Neonatal Consortium (INC), responsible for the overall strategic planning, management, financial oversight, and activities of collaborative research endeavors with various stakeholders to accomplish the objectives of INC. The Director of Pediatric Programs will also lead the launch of a consortium focused on the pediatric medical device ecosystem. Through presentations and scientific publications, the Director of Pediatric Programs communicates the vision of C-Path's pediatric initiatives to key stakeholders, including pharma, academic, patient foundations, and government participants; existing and potential funders; strategic partners and the scientific community.
Essential Job Duties and Responsibilities:
Provide overall leadership and coordination as well as administrative and scientific oversight of the Initiative's activities.
Provide scientific input to individual workgroup discussions dealing with clinical and scientific issues relating to the work of the consortium/initiative including data sharing, model informed medical product development, biomarker and clinical outcome assessments (COA) as appropriate.
Foster relationships with key individuals among regulatory bodies, consortium members, and 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 medical product development as appropriate.
Establish and lead 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 consortia/programs 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.
Education and Training:
A PhD (or equivalent doctoral degree) in Pharmacology, Biology, Chemistry, Genetics, Biomedical Engineering, or related scientific discipline. Training or experience in pediatrics or neonatology is highly desirable.
Seven to ten years' experience in medical product development (drug discovery, mechanistic pharmacology, safety assessment, clinical development, project management or regulatory affairs in the pharmaceutical or device industry, academia, and/or FDA/EMA).
Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of pharmaceutical products, diagnostics, and/or devices.
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 medical product 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 medical product 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.
Telecommuting is allowed.
Internal Number: DirPEd
About Critical Path Institute
Critical Path Institute, or C-Path, is a nonprofit organization that brings together biopharmaceutical firms,
universities, patient groups, and regulatory agencies from around the world to improve public health.
Together, these stakeholders work to identify or create tools that can accelerate the drug development and regulatory review process.