Overview
The Clinical Development Director - Hepatology provides clinical and scientific insights and leadership to clinical and translational studies or programs within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The appointed individual will work within project teams to plan, execute, and deliver activities including hepatology translational and clinical development strategies and clinical studies, particularly within the area of steatotic liver disease (SLD). You will work cross-functionally to develop and execute clinical development plans up to, and including, Proof of Mechanism/Proof of Concept studies.
This role offers the opportunity to lead key activities to progress your career. Responsibilities include the following.
Key Accountabilities / Responsibilities
* Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of IEP and CDP. Develop sections of core regulatory documents.
* Generate the data and evidence required to determine a target or medicines\' potential efficacy, safety profile, key areas of product 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.
* Seek and maintain relationships with program counterparts in Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
* Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.
* Clinical Development Strategy; Study & Program Design: Provides effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
* Contributes to the study team discussions on indication planning, incorporating input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc.) to contribute to deliverables including early Medicine Profile, Target Validation, Translational Plans, Candidate Selection.
* Designs clinical development plans and study protocols across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance).
* Develops clinical study protocols, amendments, investigator brochures, clinical study reports, etc.
* Inputs to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
* Provides medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician. If physician, accountability 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 CMT on an EPU program. Serves as a clinical point of contact for indication of an asset (Pre-POC and single indication) or for a clinical study. Represents the clinical matrix team at EDT or clinical study at CMT.
* Collaborate with cross-functional teams to ensure cohesive translational and clinical development plans. Act as Clinical Lead at study level.
* Lead end-to-end clinical development strategy for an EPU program and participate in later stages as applicable. Serve as primary clinical contact for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
* Serve as the primary clinical interface with the relevant internal RIIRU/GSK review boards.
* Evaluate business development opportunities from a clinical perspective.
* Stay informed of hepatology research advancements, trial methodologies, regulatory space, and competitive landscape to maintain GSK\'s competitive edge. Identify transformational opportunities where projects offer significant patient benefit.
* Gather and integrate inputs from scientific, clinical, commercial, and regulatory teams to contribute to the clinical components of the Medicine Profile. Contribute to solving study and overall clinical development plan problems.
* Contribute to the implementation of strategic initiatives within the EPU and demonstrate ability to influence others at project, departmental, and inter-departmental levels.
* Influencing and Inspiring Others, Managing Conflict: Inspire others by setting a positive example, communicating a clear vision, and creating an environment where team members feel valued.
* Experience in managing conflicts effectively and independently, and negotiating mutually acceptable solutions.
* Achieve outcomes through strong influencing skills, understanding others\' perspectives, building trust, tailoring communications, and using persuasive arguments.
* Enterprise Mindset and Navigating Ambiguity: Demonstrate flexibility in changing environments, analyze incomplete information, identify risks, and make informed decisions. Collaborate across the matrix and integrate cross-functional knowledge into decision-making while balancing team objectives with broader business goals. Embrace challenges as opportunities for innovation and leverage digital tools to create improvements. Proactively generate ideas and foster an environment for others to do the same.
Qualifications
* Basic Qualifications: PhD or PharmD (or equivalent) with 1-3 years postgrad experience in a relevant field. Minimum of 3 years of experience in clinical research and development. Knowledge of translational studies, generation and analysis of human translational data, and preclinical biological experiments. Robust knowledge of hepatology research priorities, regulatory landscape, and clinical practice trends. Experience with global regulatory agencies and management of global hepatology clinical trials. Knowledge of GCP and ethical guidelines.
* Preferred Qualifications: Medical Degree preferred; board certified/eligible in hepatology; general internal medicine experience for MDs or related disease-area experience.
Why GSK?
GSK is a global biopharma company focused on uniting science, technology and talent to advance health. We value Patient focus, Transparency, Respect, Integrity, Courage, Accountability, Development, and Teamwork. We are an Equal Opportunity Employer and provide an agile working culture. We encourage inquiries about adjustments in the recruitment process.
Contact and Additional Information
For adjustments: UKRecruitment.Adjustments@gsk.com or 0808 234 4391 (hours 8:30am–12:00 noon, Monday to Friday; times may vary on bank holidays). If your inquiry is not about adjustments, please consult our UK Recruitment FAQ guide in the Careers section.
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