PATH current employees - please log in and apply PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world's most pressing heath challenges. PATH's Center for Vaccine Innovation and Access (CVIA) brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA's current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against fifteen different diseases. Our focus is on vaccines to address the leading diseases that claim children's lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others. PATH has led numerous global partnerships, including the award-winning Meningitis Vaccine Project and the Malaria Vaccine Initiative, which helped develop the first malaria vaccine candidate recommended for pilot implementation.The Senior Medical Officer will be responsible for a range of clinical trial activities in CVIA, including lead roles in development of clinical research plans (from phase 1 through post-marketing), pharmacovigilance, development of protocols and related documents (IC, CRFs, CSRs, etc.) and oversight of their implementation. Additionally, the Senior Medical Officer will lead efforts, in coordination with external partners, to develop and test vaccines for licensure.ResponsibilitiesReporting to the Medical Officer Team Lead, the Senior Medical Officer will both lead and participate in multi-disciplinary vaccine product development. The ideal candidate will have deep experience and flexibility to serve as both a Medical Officer and Project Leader in one or more project(s) where PATH is involved in clinical activities. Responsibilities include:Provide leadership and medical expertise in the planning and implementation of CVIA-supported vaccine clinical trials and related activities (e.g., epidemiological studies, vaccine preparedness studies, effectiveness studies, post-marketing pharmacovigilance, development and training of key staff, etc.).Plan and participate in the implementation of a broad portfolio of clinical research that evaluates a wide range of vaccine candidates of importance in developing countries.Serve as medical officer for CVIA clinical trials, responsible for leading, managing, and coordinating clinical trials of candidate vaccines, all the way from Phase 1 through post-marketing studies. This includes:Participate in the selection of clinical sites and CROs, including site visits to evaluate and identify needs and gaps of potential clinical sites.Review clinical laboratory activities to ensure proper handling and testing of specimens.Review clinical sites' pharmacy plans and activities.Troubleshoot issues of operational compliance or other problems impacting trials progress and quality.Oversees protocol implementation, including safety oversight, pharmacovigilance and ethical compliance.Participate in the development and/or review of protocols and ICDs, CRFs, SOPs and other documents.Monitor clinical trial progress, relevance and merit.Determine the need for and/or make site visits to plan and on-site evaluate clinical trial efforts; initiate appropriate action when research progress is inadequate.May serve as an overall project leader for select CVIA projects to include:Provide matrix management and leadership to project team members; ensure every team member understands their respective duties and responsibilities, and that functional sub-teams are attaining their key deliverables.Lead the initial drafting and/or continuous refinement of the value proposition, target product profile, results framework, and detailed integrated product development plan (IPDP)/life-cycle management plan (LCMP), ensuring alignment with PATH's mission, values, and policies.Direct the generation of budget, establish project milestones and success criteria, and timeline estimates by functional experts, and communicate to sponsors and donors.Ensure execution of the IPDP/LCMP as agreed with partner(s) and donor(s).Proactively identify issues and mitigate risks, resolve conflicts, and communicate project-related issues to senior management.Foster critical thinking and accountability by promoting effective decision-making, planning towards milestones, defining clear go/no go decision points, creating scenario plans, and overseeing management of critical path activities.Oversee project management activities in collaboration with the project team members to allow course correction for activities on critical path.Manage and ensure effective relationships with development partner(s) and donor(s) through clear and timely communication, diplomacy, and achievement of milestones and deliverables.Create strategic linkages between the project teams and other vaccine development projects within CVIA to maximize experience and use of resources.Oversee annual work plans and compliance with all donor requirements; review and approve project progress reports to donor(s), prepare for and represent project at scheduled meetings with partner(s) and donor(s).Required skills and experienceMedical Doctorate (MD) degree, or equivalent, with experience developing clinical development plans, study protocols, and monitoring clinical studies.Minimum of 15 years of relevant product development experience in the pharmaceutical, life sciences or related industry, with strong preference for significant experience in vaccine developmentDemonstrated leadership and project/program management skills as evidenced by leading, planning, developing and managing complex clinical trials program.Experience with international clinical research, preferably research carried out in resource-limited settings.Knowledge of world-wide pharmaceutical and regulatory requirements, including GCP, ICH, and other Guidance documents and policies related to clinical trials required by FDA, EMEA, WHO and equivalent international regulations.Knowledge of clinical trial operations, regulatory requirements, procedures, and policies.Ability to work effectively with colleagues from myriad cultures, backgrounds and geographies.Proven ability to write in a clear, concise, and organized manner and make clear and convincing oral presentations as needed.Proven ability to develop networks and build alliances; collaborate across boundaries to build strategic relationships and achieve common goals. Open, engaging, and transparent work style. Comfortable questioning the status quo and advocating for different opinions with internal and external partners.Working-level proficiency in Microsoft Office products (Teams, Outlook, Word, Power Point) and cloud-based document management.Ability and willingness to travel domestically and internationally, up to 25% of the time, when required.Ability to communicate fluently in English.Ability to work flexible hours in a global environment.Must have legal authorization to work in the US, Belgium, Switzerland, UK, Kenya, or South Africa. Fully remote candidates in these locations will be considered.
