Behavioral Health Medical Director responsible for oversight and clinical education in behavioral health services for CareBridge. Working part - time to develop programs and conduct clinical consultations.
GS
Hybrid Senior Medical Director, Clinical Development, Advanced Pipeline Unit – Hepatology
Posted 13 hours ago
About the role
- Senior Medical Director managing clinical development strategies in Hepatology at GSK. Leading innovative clinical trials and ensuring regulatory compliance across multiple projects.
Responsibilities
- 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
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