Collaborates closely with Medical (GME/PMSL), Clinical Study Management teams in site and investigator selection and discusses options to ensure alignment with the CDP after obtaining input from regional stakeholders such as medical affairs representatives, regulatory affairs, etc.

Engages in discussion with Clinical Operations Leader, Clinical Study Management, GBS and other members of the clinical team to ensure that studies are feasible and meet ICH-GCP quality and compliance standards; is a key source of information and education for internal and external stakeholders on ICH-GCP and regulatory requirements

Is accountable for global protocol and amendments development in order to obtain regulatory approval; ensures consistency across trials in the project in terms of site selection approval process, safety data quality review, audit preparations, study specific safety follow-up reports, interim analysis, iCSR and dear investigator letter development.

Follows a consistent format and approach to investigators meetings, independent data monitoring committee meetings, safety management team meetings, product safety board meetings, clinical-regulatory strategic forum presentations, project team meetings

As appropriate, the lead GCDSE will support other GCDSEs to align on the CDP in the management of activities in their respective country/region

Is the clinical representative in the Global Project Team, or supports the Senior Global Clinical Development Strategy Expert in their role as primary clinical representative.

Is accountable for the timely reporting of project status to senior management and ensuring execution of project deliverables in coordination with clinical team members.

Provides details of clinical assumptions that need to be factored into timing considerations, budgetary and resource planning processes

Provides clinical input to regulatory strategy and submissions for clinical studies they are leading.

Leads the creation of medical/clinical content of study documents (including briefing packs) and validates with GSO SAE management processes for the study, in conjunction with Global Pharmacovigilance and other representatives of the Project Team.

Responsible for the review and approval of clinical sections of the Common Technical Document/local dossier for submission for licensure

Responsible for responding to clinical questions relating to the CTD/local dossier from Health Authorities

Coordinates clinical development responses to health authorities (ethical committees, national regulatory agencies, ministries of health), to assure consistency, engaging other GCDSEs, central / regional /local teams and clinical operations as needed, in conjunction with the central RA representative of the Project Team.

Attends relevant meetings with CTD task force and RA  meetings relating to licensure

Interacts with regulatory authorities and other external parties as appropriate to review the conduct and / or data from the clinical program; engages in 'end-of-phase' meetings to discuss scientific points, Q&A on submitted data

Provides clinical and scientific support to epidemiology studies that are led by the epidemiology platform.

Provides medical guidance related to the safety and wellbeing of study subjects and is responsible for ensuring the safety of research subjects in clinical trials*; (*If not a physician, requires supervision by a physician)

Is the medical expert on call for site audits and inspections (will delegate as appropriate to GCDSE in regions or countries);

Proactively communicates any potential issues to central / regional teams and clinical R&D management and plays an active role in solving problems and issues.

Ensures a consistent, systematic approach to the analysis and interpretation of efficacy, immunogenicity and safety data. 

Leads the interpretation and critical evaluation of study results. Authors and reviews clinical study reports and clinical documents required for regulatory submissions.

Meets with a) the (extended) clinical team and b) the global project team to report and discuss results.  Also engages Global Head of Clinical Franchise as appropriate for review and discussion of results; includes analysis of data, impact on strategy, risk analysis, possibility of modifying program.

Makes recommendations to Clinical Regulatory Strategic Forum (CRSF).

Makes recommendations to Clinical Regulatory Strategic Forum (CRSF).

Clinical Development representative of the Publication Working Group (PWG) and, when applicable, the Publication Steering Committee (PSC);

Author/Co-author of the publications of the study they are involved in.

Attend/present results in Scientific Meetings or Congresses.

Preparation of presentation materials; presents study results internally to senior management and presents externally to investigators, outside partners, regulatory and public health agencies

Development and active management of investigator / expert networks; Leads the development of appropriate messages and sequencing of communications to ministries of health and other public health agencies; works with colleagues in GRA and GMS to agree on level, content and timing of communications to authorities and the scientific community

Proactively communicates with colleagues on both central, regional and local teams, providing up-to-date and pertinent scientific and medical information, as well as public health activities and trends in the country/region (e.g. new epidemiological information, regional / local immunization calendars)

Engages in due diligence/technical assessments of potential internal and external vaccine candidate products as needed

Actively networks with investigators and public health representatives, and builds relationships with key stakeholders and decision-makers in local health systems and government institutions

Supports media events related to R&D or specific programs, and where requested also product launch activities from an R&D perspective as appropriate

Participates in the development and implementation of  Scientific Advisory Boards as appropriate

Engages in country/regional scouting activities and due diligence of potential external vaccine candidate products as needed

Scans countries/regional initiatives regarding new products development, liaising with local/regional agencies, institutes, universities, companies in order  to understand regional needs and provide due diligence support to central teams

Determines which competitive products are in development in the country/region and reviews the likely impact on future opportunities for products in development in the country/region.

Periodically reviews and expands the PI network participating in vaccine trials.

Establishes or at request occasionally supports GMS initiated KOL activities

Ensures that the global strategy is implemented in their region/country

As appropriate, and dependent on Clinical Project needs, the lead GCDSE liaises with other GCDSEs in defining their specific roles and responsibilities in the management of a variety of clinical trial activities:   a) Managing the concept document; b) ensuring the Statistical Analytical Plan is in alignment with the CDP; c) safety monitoring and management (e.g. ensures ethical treatment of subjects enrolled in clinical trials and oversight of their safety); d) Investigator's Brochure (IB)

Protocol writing, study conduct and CSR writing for selected, regionally/country- focused studies as agreed with central team

Responsible for sharing the study data with the investigators at a reasonable and appropriate time, and is actively involved with presentation and publication of data obtained from regional studies

Following study closure, ensures a consistent, systematic approach and provides feedback on study results to regional / local investigators, regulatory and public health agencies

Is current with required ICH-GCP, technical and SOP training and maintains up to date training records

Ensures that all clinical trial activities in the Project /program comply with the highest quality and ethical standards and that strict confidentiality is maintained

Provides mentoring and training support for new and recent hires (in both central and regional locations) in the clinical department as required

Initiates and provides support for process improvement initiatives in the Global Clinical Development department

Physician, with training in Pediatrics or Internal Medicine in addition to training or experience in immunology or infectious diseases, preferred. MD, PhD or PharmD is a minimum scientific qualification.

3-5 years Pharmaceutical industry experience preferred or

5 years or more experience conducting clinical trials in an academic environment or

Equivalent experience in epidemiology, public health and infectious disease research.

Demonstrated scientific productivity (publications, research reports, etc.) and ability to critically review/interpret research data, preferred.

Demonstrated planning, organizational skills, interpersonal, problem solving and excellent written and verbal communication skills.

Ability to work independently across many interfaces and platforms in a highly matrixed, cross cultural environment is essential.

Written and oral fluency in English and Japanese required,

Knowledge about local clinical requirements, clinical/medical practice to discuss with local Health authority