Project Physician

About this role

Responsibilities

• Work in a Clinical Development sub-team of clinical and regulatory colleagues (clinical development, clinical operations, biostatistics & regulatory associates), and in collaboration with non-CDRA members of the GVGH Project Team(s), with the responsibility to author clinical development plans, design clinical trial protocols, write Investigator Brochures, clinical study reports and publications of the project(s) to high scientific, operational and ethical standards.
• Address scientific and medical issues related to trials of the project(s) in GVGH.
• Be responsible (or provide oversight of delegated CRO medical monitoring team) for Medical Data Listing review, ensuring medical consistency within trial and across trials within the project.
• As a member of the Safety Review Team, be accountable (through providing oversight if applicable of delegated CRO medical monitoring team) for medical assessment of serious adverse events, adverse events of special interest (AESI’s) and other events occurring during clinical trials and pay attention to potential safety signals.
• Additionally, participate in individual case safety report compliance activities and take the necessary corrective actions.
• Handling and/or coordinating studies with human biological samples using GVGH WS/GSK policies.
• Support the Senior project physician Lead in representing GVGH in meetings with health authorities and the scientific community, network with thought leaders and international agencies, on specific GVGH vaccines related project matters.
• Contribute to creation, review and revision of standards (e.g., SOPs, Work Instructions) on clinical development, regulatory and drug safety activities.
• Maintain/expand knowledge in vaccines, clinical trial methodology, and drug safety competencies including national and international regulations and Global Safety policies/procedures.
• Serve as the principal liaison to GVGH Safety and Data Management Committees: SRT, Internal Safety Review Committee (iSRC) and Independent Data Monitoring Committee (IDMC).
• Where applicable, lead matrix team, to author program strategy, clinical development plans and design clinical trial for governance meetings and ensure consistency of data within program and across projects. Reporting accountability will be to the Senior Project Physician Lead.
• Budget, resourcing and timing
• Supports the clinical team to consistently achieve high standards and attainment of project timelines in global programs.
• Interfaces with the SDL to ensure milestone realization and resource optimization.
• Why you?
• Basic Qualifications & Skills
• We are looking for professionals with these required skills to achieve our goals:
• Doctor of Medicine with advanced university degree (Masters or PhD) and Board certification. In order of preference: vaccinology, infectious diseases, global health, pediatrics.
• At least 2-3 year experience in industry clinical development and/or drug safety in a pharmaceutical company or 10 years working in a scientific or medical Institution.
• Medical and scientific knowledge and track-record in infectious diseases through training and practice and the ability to function independently while supervised with significant experience in clinical development and drug safety in academia or industry.
• Demonstrated experience and initiative in finding solutions to challenges in the clinical development space in LMICs is a key attribute.
• Preferred Qualifications & Skills
• If you have the following characteristics, it would be a plus:
• Innovative problem solving is a desirable requirement due to the need to provide balanced clinical and ethical guidance, particularly in the sites and countries where some of the GVGH clinical trials may take place.
• Strong clinical leadership and excellent interpersonal and communication skills to work effectively with internal GVGH/GSK project teams, CRO partners, external clinical site teams and international scientific and funding stakeholders.
• Proven ability to interact with tact, respect and cultural sensitivity with diverse stakeholders, including opinion leaders, doctors, patients, health workers and community leaders in LMIC settings.
• High level of impact and accountability for project success in clinical development and drug safety, including independent issue resolution and decision-making.
• Demonstrated ability to generate, interpret and communicate complex clinical data, taking end-to-end responsibility for results, reporting and scientific dissemination with limited supervision.