About the Role
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 health 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.
PATH is currently recruiting a Senior Medical Officer who will be responsible for a range of clinical trial activities of PATH’s CVIA, including lead roles in development of clinical research plans (from phase 1 through post-marketing), vaccine introduction plans, pharmacovigilance, development of protocols and related documents (IC, CRFs, CSRs, etc.) and oversight of their implementation.
Plan and participate in the implementation of a broad portfolio of clinical research that evaluates a wide range of novel 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.
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 insure proper handling and testing of specimens.
Participate in the development and/or review of protocols and ICDs, CRFs, SOPs and other documents.
Review clinical sites’ pharmacy plans and activities.
Troubleshoot issues of operational compliance or other problems impacting trials progress/quality.
Oversee protocol implementation, including safety oversight, pharmacovigilance and ethical compliance.
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 validation of new diagnostic tools and immunological assays on-site training of key staff, etc.).
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.
A minimum of a Medical Doctorate (MD) degree or equivalent.
A minimum of ten (10) or more years of experience in clinical research related to the position, including experience and leadership roles in phase 1, 2, and 3 clinical trials.
Deep knowledge of vaccine research, development and deployment encompassing the latest developments and advances in the field required.
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.
Demonstrated leadership and project/program management skills as evidenced by planning, developing and managing complex clinical trials program.
Experience with international clinical research, preferably research carried-out in developing countries.
Ability to work effectively with colleagues from myriad cultures, backgrounds and geographies.
Fluent oral and written communication skills in English.
Strong verbal and written communication skills necessary; must be able to work within existing organizational structures and interact with individuals of varying expertise.
Open, engaging, and transparent work style. Comfortable questioning the status quo and advocating for different opinions with internal and external partners.
Ability and willingness to travel domestically and internationally as needed, approximately 5-10% of the time.
Must have legal authorization to work in the United States.
PATH is a diverse nonprofit organization that creates a culture of collaboration and partnership. Learn more about the impact you can make globally here.
We offer our employees a competitive salary and generous benefits. For candidates based in the U.S., the annual salary range for this position is $190,900-$292,732. The final salary is based on a variety of objective factors.
PATH provides a comprehensive benefit package that includes 15 vacation, 10 holiday, 2 personal and 12 sick days per year; medical and dental plans; life insurance; disability and retirement benefits. For more details click here.
PATH operates within a hybrid workplace model unless otherwise noted. Hybrid employees must reside within commuting distance to one of our PATH offices. PATH’s US offices are located in Seattle, WA and Washington, DC.
COVID-19 Vaccine Requirement
PATH has instituted a COVID-19 vaccine mandate for all employees, interns, consultants, and temporary staff based in the United States. Individuals selected for job opportunities in the United States must be fully vaccinated, and show proof of vaccination status, upon hire. Individuals are considered fully vaccinated 2 weeks after their second dose in a 2-dose series, such as Pfizer or Moderna, or 2 weeks after a single-dose vaccine, such as Johnson & Johnson. Individuals with medical issues or sincerely held religious beliefs that prevent them from getting the vaccine may request an exemption from the vaccine requirement.
PATH is dedicated to building an inclusive workforce where diversity is valued.
PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Seattle, WA or Washington, DC, United States
United States, Seattle or Washington, DC