Medical Director Clinical Development- Aging

Medical Director Clinical Development
- Aging

GSK is seeking an experienced Medical Director Clinical Development
- Aging to join GSK's Respiratory, Immunology & Inflammation Research Unit. In addition to providing clinical and scientific leadership to clinical and translational studies or programs for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion, and innovative clinical development opportunities. You will work cross-functionally to develop and execute clinical development plans (CDPs) and contribute to above-project development of foundational and real-world data, and translational and biomarker capabilities, within a department that prioritizes understanding mechanism and unmet need alongside innovative clinical development, helping us deliver differentiated medicines that change the course of disease and improve patients' lives.

This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

Position Summary:

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:

• Support alignment of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP. Develop sections of core regulatory documents.
• Generate the data and evidence required to determine a target's potential efficacy, safety profile, key areas of differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.
• Define and deliver the clinical pillars of the translational table.
• Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism, and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP
• Establish and maintain relationships with program counterparts in Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs and Statistics.
• Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.

Clinical Development Strategy and Study & Program Design

• Provide effective support and oversight of R&D evidence generation strategy, plan, and activities to ensure patient safety and on-time, in-full study delivery. Contribute to the study team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc.) to contribute to vital deliverables including early medicine profile, target validation, translational plans, candidate selection.
• Design clinical development plans, study protocols, and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance).
• Bring clinical expertise to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
• Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician.
• Accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.

Clinical Leadership

• Accountable for leading the Clinical Matrix Team (CMT) for a program. Serves as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study. Represents the CMT at Early/Medicine Development Teams or clinical study at CMT.
• Actively leads the end-to-end clinical development strategy for an early program and may contribute to later stages.
• Serve as the primary Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board.
• Assist with clinical evaluation of business development opportunities
• Stay abreast of advancements in research, clinical trial methodologies, competitive environment, and regulatory space in the relevant disease area to maintain GSK's competitive edge.
• Identify and highlights transformational opportunities, where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
• Gather and supports the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile (MP).
• Consistently contribute to solving study and overall clinical development challenges.
• Demonstrate ability to influence others at project, departmental and…