Contribute to the clinical development strategy for a drug or program
Ensure execution of clinical development plans (CDP) for product(s) and/or indication(s) and provide strategic oversight and management of clinical trials
Lead clinical development activities from a therapeutic area and clinical trial perspective, including: Provide clinical and medical oversight of ongoing clinical trials
Lead clinical trials and asset-level activities in a matrix team structure
Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients
Contribute to development of the Integrated Evidence Strategy (IES)
Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and trials
Contribute to clinical development discussions and teams at global regulatory interactions
Draft clinical components of global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions
Promote innovative methodologies and processes including digital tools, encouraging others to think differently and adopt new ways of working
Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK’s competitive edge

Requirements

Medical degree and clinical medical specialty training board qualification/registration in Internal Medicine or Primary Medical
Experience in the global pharmaceutical/biotechnology industry in the field of Hepatology
Experience in clinical research and drug development, with a focus on SLD, including ALD and MASH
Experience in late-stage Hepatology drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure
Experience in medical monitoring activities and oversight
Experience in leading regulatory submissions and managing global clinical trials
Experience with ICH and GCP guidelines and regulatory requirements
Matrix team experience within a clinical development setting

Benefits

health care and other insurance benefits (for employee and family)
retirement benefits
paid holidays
vacation
paid caregiver/parental and medical leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical development strategyclinical development plansclinical trialsmedical oversightregulatory submissionsclinical researchdrug developmentPhase 2 clinical trial designPhase 3 clinical trial designmedical monitoring

Soft Skills

strategic oversightleadershipcommunicationcollaborationinnovationproblem-solvingteam managementadaptabilitycritical thinkinginterpersonal skills

Certifications

medical degreeclinical medical specialty trainingboard qualification in Internal Medicineregistration in Primary Medical