Descrizione:
Position Summary
Lead Clinical Development of one or more GVGH Vaccine Development Programmes, encompassing design and set-up of GVGH-managed clinical trials. Serve as lead author or key contributor of clinical and epidemiology plans, clinical trial protocols, reports, publications, and regulatory submissions. Hold medical monitoring responsibility for clinical trials and participate as a member of the cross‑functional Safety Review Team coordinated by SERM.
Responsibilities
Author clinical development plans, design protocols, write Investigator Brochures, study reports, and publications to high scientific, operational, and ethical standards.
Address scientific and medical issues related to GVGH trials.
Oversee Medical Data Listing review, ensuring consistency within trials and across the project.
As a member of the Safety Review Team, assess serious adverse events, adverse events of special interest (AESI’s), and other events, monitoring for potential safety signals.
Participate in individual case safety report compliance activities and implement corrective actions.
Handle and coordinate studies involving human biological samples under GVGH WS/GSK policies.
Support the Senior Project Physician Lead in representing GVGH at health authority meetings and scientific community engagements.
Contribute to creation, review, and revision of SOPs and Work Instructions related to clinical development, regulatory, and drug safety activities.
Maintain knowledge in vaccines, clinical trial methodology, and drug safety competencies, including national and international regulations and Global Safety policies.
Serve as the principal liaison to GVGH Safety and Data Management Committees: SRT, iSRC, and IDMC.
Lead matrix teams when applicable, author program strategies, and design clinical trials for governance meetings, ensuring data consistency across programs and projects.
Support the clinical team to achieve high standards and project timelines in global programmes.
Interface with the SDL to ensure milestone realization and resource optimization.
Basic Qualifications & Skills
Doctor of Medicine with an advanced university degree (Master’s or PhD) and Board certification. Preferred specialisations: vaccinology, infectious diseases, global health, pediatrics.
At least 2–3 years of industry clinical development and/or drug safety experience in a pharmaceutical company, or 10 years in a scientific or medical institution.
Strong medical and scientific knowledge with a track‑record in infectious diseases and the ability to work independently under supervision.
Demonstrated experience in solving challenges in clinical development, particularly in low‑ and middle‑income countries (LMICs).
Preferred Qualifications & Skills
Innovative problem‑solving skills to provide balanced clinical and ethical guidance, especially in LMIC settings.
Strong clinical leadership and interpersonal communication skills for collaboration with internal and external partners.
Ability to interact respectfully and culturally sensitively with diverse stakeholders, including doctors, patients, and community leaders in LMICs.
High level of impact and accountability for project success, including independent issue resolution.
Proven ability to generate, interpret, and communicate complex clinical data and conduct end‑to‑end reporting and dissemination with limited supervision.
Benefits
Permanent contract in an inclusive environment.
Flexible benefits and company healthcare plan.
Integrative pension fund and employee assistance programme.
Prevention services and vaccination clinic.
Tax assistance and local nursery agreement.
On‑site gym, canteens, coffee corners, and free company bikes.
Shuttle service.
Salary
Italian Salary Range: EUR 60,000 to EUR 100,000 (annual gross base salary).
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. All qualified applicants receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service, or any basis prohibited under federal, state, or local law.
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