POSITION SUMMARY:

In 2021 and 2022, a massive COVID vaccine deployment program will be implemented in Africa. This program will include both clinical trial and other data generation activities, that are part of the Integrated Evidence Generation Plan (IEGP).

This position directs study design, protocol development and execution of clinical research in all phases ensuring consistency and quality across the program.  He/she, represents the clinical team in governance and committee meetings relating to the overall strategy and operational implementation of the clinical studies in the developmental plan.
He/she provides mentoring and coaching support to the Study Responsible Physicians on the teams and works with PMO, finance, and clinical leadership to assure appropriate resourcing of clinical studies.  This position will provide cross program advise on medical and safety risks and challenges in low- and middle-income countries to the GPH Study Responsible Physicians and Clinical Scientists in the Capacity Development Group and stakeholders of the broader GDO organizations,.

ESSENTIAL FUNCTIONS:

Lead the Study Responsible Physicians (SRPs), ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development programs and/or IEGP.

• Work closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders.
• Provide support for clinical study/studies within a development program including: list programs
• Working closely with the colleague study responsible physicians and clinical project scientists in collaboration with GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events, adverse events of special interest and deaths. This also includes the evaluation of local safety reporting processes and capabilities and initiate the necessary mitigations and human and infrastructural capacity building efforts if required.
• Working in partnership with colleague study responsible physicians and clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies.
• Collaborate with the Clinical Leader, Clinical Project Scientists and Procurement on key study design elements including assessment of complexity and cost of protocol-required evaluations.
• Participate in strategic study start-up planning in collaboration with CDG Clinical Scientists, GCO, contracts and grants, and RTAEs including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate rate of site activations.
• Co-lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents.
• Work closely with Medical Writing to support protocol or protocol amendment completion.
• Work closely with Clinical Leader, Project Physician, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
• Work closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment.
• Work closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans.
• Work closely with clinical scientists and data management to support medical review and data query resolution.
• Interact with clinical investigators and Key Opinion Leaders as appropriate.
• Work with GCO to provide oversight of CRO/study vendors’ performance as it relates to study start-up and conduct.
• Work with the Clinical Leader, if applicable, with Data Management and with Statistics on analysis of study results and completion of study reports.
• Work with the Clinical Leader to support the development and compilation of NDA/MAAs and to support responses to Health Agency questions and HA presentations post-filing.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Qualifications

PRINCIPAL RELATIONSHIPS:

Contacts Inside the Company:

• GPH R&D Capacity Development Leader and Scientific Liaison
• Clinical and Compound Development teams in GPH R&D and vaccines organization
• GPH MAF and marketing/Access organization
• African Implementation and Impact Group

Contacts Outside the Company:

• Trial PI and staff
• Health Authorities
• NGOs and Academic organizations

Supervision:

Name: Head GPH R&D Capacity Development Group