The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate.

As the leader of the Clinical (or Extended Clinical) Team, the GCDSE is the clinical representative in global project teams (GPT). The GCDSE is a subject matter expert in the disease area of the programs covered. The GCDSE is accountable for and leads the discussion of CDP and relevant study documents including protocol and results with regulatory authorities, other external bodies such as Independent Data Monitoring committees and Advisory Boards; the GCDSE supports other GCDSE colleagues elsewhere for such interactions with similar bodies, if this responsibility is delegated, while assuring global consistency. The GCDSE is also responsible for country / regional / global interactions with regulatory and public health agencies, governments and supranational non-governmental organizations, key opinion leaders and investigators as required. They also collaborate closely with regional R&D, global medical affairs, and country managers. As such, they have global/local responsibility and ownership for clinical sections of the Common Technical Document (CTD) /local dossiers as well as for interactions with Regulatory Affairs for pre-submission and submission meetings with Agencies (e.g. PMDA, NDA, etc).

The GCDSE establishes the conditions essential for determining the safety of all subjects involved in Clinical trials for the vaccine development candidates they oversee. They are also accountable for the ethical integrity of clinical plans, adherence to the highest ethical standards of Clinical trial conduct and adherence to all GCP requirements concerning human subjects. The GCDSE will execute the CDP as close as possible to company optimized timelines. The GCDSE performs medical monitoring activities for studies within the country, region or on a global level as appropriate, addressing any medical questions the site investigative teams have regarding clinical protocols, and monitors study conduct in close collaboration with study management & logistics and Global Pharmacovigilance.

CDP implementation
As team leader of the clinical study team, is accountable for the implementation of all clinical activities to move vaccine candidates through development, registration and commercialization in accordance with established ICH-GCP guidelines.

• 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

Project Planning and Reporting

• 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

Regulatory Support

• 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

Epidemiology

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

Medical Monitoring
Brings medical and scientific expertise to bear when acting as the medical monitor for clinical studies:

• 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.

Medical/Scientific Data Interpretation and Communication

• 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).

For Publications

• 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.

As An Ambassador For Clinical R&D Is Accountable For

• 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

Plays a role in the gathering of country/regional competitive intelligence:

• 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

Study Execution, Management and Logistics
Provides input to regional or country (as applicable) regulatory strategy and submissions; validates medical content of study documents and validates SAE management processes at a country / regional level. Coordinates with central teams and clinical operations to compile clinical development responses to health authorities (ethical committees, national regulatory agencies and ministries of health) assuring good quality, timely finalization and follow up on the submission through clinical operations.

Brings country/regional and medical expertise to bear when acting as the country/regional medical monitor in support of central teams or for country/regionally initiated and led studies; provides medical guidance including related to the safety and well-being of study subjects; is country/regional medical expert accountable for responding to questions from clinical operations or auditors / inspectors for site audits and inspections; proactively communicates any potential issues to central / regional/country teams and clinical management and plays an active role in solving problems and issues.

• 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

Additional Accountabilities

• 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

Interfacing Between Development Sciences And Operations
The GCDSE is the clinical/medical/scientific expert who supports the translation of a target product profile into a feasible CDP, taking into account scientific environment, resource possibilities, clinical feasibility and timely execution. This requires a good understanding of the possibilities and limitations of the operational environment, team leadership skills, communication skills, knowledge of the therapeutic area, ability to understand business needs and how to translate them into feasible operational plans.

Team Leadership
The GCDSE leads the clinical study team and as such requires leadership skills, communications skills, ability to operate in multidisciplinary and multi-cultural teams, ability to inspire teams.

Requirements
Education/experience:

• 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

Certifications
M.D. or PhD Completion of an approved residency training program in a related field or equivalent is preferred

Selling Point

• Global Leadership:

Spearheads global clinical strategy and protocol development, ensuring consistency and scientific excellence across regions.

• Cross-Functional Expertise:

Acts as the clinical voice in global project teams, regulatory discussions, and public health engagements, bridging science, operations, and strategy.

• Ethics & Innovation:

Drives high-standard, ethically sound clinical trials while contributing to global vaccine advancement through medical monitoring and data-driven insights.

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