Clinical Development Director - Hepatology

Role Summary

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 plan(s) up to, and including, Proof of mechanism/Proof of concept studies.

Responsibilities

• Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of IEP and CDP. Will develop sections of core regulatory documents.
• Generate the data and evidence required to determine a target or medicines‚Äô 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, incorporates 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.
• 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 both internally and externally for an indication of an asset indication (i.e. 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, including biology, translational, regulatory affairs, medical affairs, and commercial teams, to ensure cohesive and comprehensive translational and clinical development plans. Act as Clinical Lead at study level.
• Actively leads the end-to-end clinical development strategy for an EPU program and may contribute to later stages. Serve as the primary 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.
• Serves as the primary clinical interface with the relevant internal RIIRU/GSK review board (ie Technical Review or governance) and/or Protocol Review Board.
• Clinical evaluation of business development opportunities.
• Stays abreast of advancements in hepatology research, clinical trial methodologies, competitive environment and regulatory space to maintain GSK‚Äôs competitive edge. Identifies and highlights transformational opportunity where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
• Gathers and supports the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile. Consistently contributes to solving study and overall clinical development plan problems.
• Contributes to the implementation and embedding of strategic initiatives and various organizational initiatives in the EPU.
• Demonstrates ability to influence others at project, departmental and inter-departmental levels, as appropriate

Influencing and inspiring others, managing conflict

• Able to consistently inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated.
• Demonstrated experience in managing conflicts effectively and independently, negotiating mutually acceptable solutions.
• Consistently achieves desired outcomes through strong influencing skills including understanding others' perspectives, building trust, tailoring communications depending on the audience and using persuasive arguments to gain support.

Enterprise mindset and navigating ambiguity

• Demonstrated flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions.
• Demonstrated enterprise mindset with effective collaboration across the matrix, able to integrate cross-functional knowledge into decision-making processes and balance team objectives with the wider business goals.
• Embraces challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areas
• Proactively generates ideas for innovative improvement and takes advantage of opportunities that arise; promotes environment for others to generate ideas for improvement

Qualifications

• PhD or PharmD (or equivalent) with 1-3 years postgrad experience in a relevant postgraduate training or job.
• Minimum of 3 years of experience in clinical research and development (may include postgrad experience)
• Knowledge of and experience in the execution of translational studies including both generation and analysis of human translational data and conduct of preclinical biological experiments in relevant model systems
• Robust knowledge of hepatology specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
• Experience working with global regulatory agencies and managing global clinical trials in hepatology.
• Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.

Education

• Medical Degree Preferred
• Board certified/eligible in hepatology
• General internal medicine preferred for MDs or alternative experience in the relevant disease area