PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide.
PATH’s work on vaccine development and introduction encompasses activities including discovery, preclinical development, process development and manufacturing, regulatory, clinical research and development, and including vaccine introduction and sustainability. Over 25 candidates and vaccines are currently in our portfolio in the following disease areas—Malaria, Enteric and Diarrheal Diseases, Polio, Respiratory Tract Infections and Meningitis, HPV and Vector-borne viral diseases (e.g., Japanese Encephalitis)—and in the cross-cutting area of Maternal Immunization. The Center for Vaccine Innovation and Access (CVIA) within PATH is advancing immunization equity and vaccination coverage to reduce vaccine preventable diseases through increasing and improving accessibility, affordability, availability, acceptability, and sustainability of essential existing and new vaccines for routine immunization and pandemic/epidemic preparedness.
Reporting to the Vice-President of PATH Essential Medicines and the Head of CVIA, the Global Head of Clinical provides leadership and management to the Clinical Functional area. This functional area provides the technical expertise, operational excellence and leadership in the clinical science of infectious diseases and is responsible for conceiving and bringing to realization all technical plans to conduct studies in humans, inclusive of Experimental Medicine through Phase 5 studies; clinical research, science, operations, quality, data management, and statistics. The Global Head of Clinical is an integral partner on the Center for Vaccine Innovation and Access (CVIA) leadership team as a change leader, strategy creator, proactive partner in developing comprehensive cross-disciplinary tactics and an enabler of exceptional execution through cross-group collaboration.
- Provides scientific and technical leadership for Clinical Development and Pharmacovigilance of across the PATH EM portfolio.
- Oversee Clinical functional activities and clinical aspects of project team work to ensure compliance with PATH policies and procedures and international standards (e.g., cGCP).
- Member of the CVIA leadership team partnering with other leadership team members to support the goals and objectives of vaccine development and introduction.
- Develop strong partnerships across the CVIA leadership team to ensure overall integrated development and introduction tactics for CVIA projects.
- Sponsor CVIA-wide and Clinical area-specific change management activities and express, model, and reinforce desired behaviors.
- Provide overall strategy for the clinical functional area within CVIA inclusive of risk assessment and regulatory pathways (the latter in collaboration with the Global Head, Regulatory).
- Oversee the PATH EM Scientific Merit Review process to ensure that investigational evaluation through human subjects research (HSR) conducted on essential medicines is scientifically meritorious and that the design, operations, risk management of the study and study protocol, and informed consent language regarding study-related injury, investigator brochure, and other clinical functional area elements related to the HSR are fit-for-purpose
- Lead the development and creation of norms, processes, standards, and documentation to ensure highest quality of clinical research and operations support to projects with a strong scientific component.
- Manage the clinical team to develop and review clinical development plans, protocols and amendments, investigator brochures, clinical sections of IND/IMPD filings, clinical study reports, and manuscripts.
- Provide clinical safety oversight, including development of risk management plans and ongoing review of safety in clinical trials and post-authorization pharmacovigilance.
- Evaluate safety, immunogenicity, and efficacy data from ongoing and completed human clinical studies (experimental medicine through Phase 5).
- Ensure understanding and ability to evaluate clinical assay performance, including analytical and clinical validation.
- Serves as the primary contact with PATH’s Center of Digital Excellence (CoDE) and drives the transformation and innovation in integrating data and digital in all the clinical work with PATH EM and sharing a visionary approach and distinctive capabilities with funders.
- Interact with partners to provide input, oversight, guidance, and evaluations of clinical development plans.
- Review manuscripts, abstracts, and presentations for scientific meetings.
- Ensure the expected results of various activities are clear, measurable, and consistent with PATH policies and mission.
- Ensure compliance with PATH policies and procedures and international standards (e.g., GCPs, ethical standards).
- Lead interactions with global health authorities and partners.
- Ensure timely and adequate talent resource allocation across vaccine development projects and activities.
- Recruit, supervise, coach, and develop staff.