PATH
Senior Medical Officer-Center for Vaccine Innovation & Access
Auditing, Taxation, Financial accounting/Operations, Payroll officer
Delhi Mumbai Maharashtra
Application Email :

Description

About the Organization:

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, finance, technology, advocacy, and dozens of other specialties, PATH develops and scales innovative solutions-including vaccines, drugs, devices, diagnostics, and approaches to strengthening health systems worldwide.

Position: Senior Medical Officer, Center for Vaccine Innovation & Access

Responsibilities:

  • Plans and participates in the implementation of a broad portfolio of clinical research that evaluates a wide range of novel vaccine candidates of importance in developing countries.

  • Serves as medical officer for CVIA clinical trials, being responsible for leading, managing, and coordinating clinical trials of candidate vaccines, all the way from Phase 1 through post-marketing studies.

  • Participates in the selection of clinical sites and CROs, including site visits to evaluate and identify needs and gaps of potential clinical sites.

  • Reviews of clinical laboratory activities to insure proper handling and testing of specimens.

  • Participates in the development and/or review of protocols and ICDs, CRFs, SOPs and other documents.

  • Reviews clinical sites pharmacy plans and activities.

  • Troubleshoots issues of operational compliance or other problems impacting trials progress/quality.

  • Oversees of protocol implementation, including safety oversight, pharmacovigilance and ethical compliance.

  • onitors clinical trial progress, relevance and merit.

  • Determines the need for and/or makes site visits to plan and on site evaluate clinical trial efforts; initiates appropriate action when research progress is inadequate.

Required Experience:

  • 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.

  • The position requires deep knowledge of vaccine research, development and deployment encompassing the latest developments and advances in the field.

  • 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.

  • Strong verbal and written communication skills necessary; must be able to work within existing organizational structures and interact with individuals of varying expertise.

How to apply



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