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 appointment will work within project teams to plan, execute, and deliver activities including hepatology translational and clinical development strategies and clinical studies, particularly within 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.
This role offers the opportunity to lead key activities to progress your career.
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 data and evidence to determine 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 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 organizational initiatives in Clinical Development.
* Clinical Development Strategy; Study & Program Design
* Provide effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
* Contribute to study team discussions on indication planning, incorporating input from across disciplines to contribute to deliverables including early Medicine Profile, Target Validation, Translational Plans, and Candidate Selection.
* Design clinical development plans and study protocols across all phases of development, reflecting internal and external stakeholder input (patients, evidence generation, regulators, payors, pharmacovigilance).
* Develop clinical study protocols, amendments, investigator brochures, and clinical study reports.
* Input to regulatory interactions and documents including briefing documents, presentations, 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, with Pharmacovigilance Physician. If physician, accountability for Medical Governance across the project to ensure scientific integrity and safety of study subjects.
* Clinical Leadership
* Accountable for leading the Clinical Management Team (CMT) on an EPU program. Serves as a clinical point of contact for an indication of an asset and represents the clinical matrix team at EDT or clinical studyReview Board as applicable.
* Collaborate with cross-functional teams to ensure cohesive and comprehensive translational and clinical development plans. Act as Clinical Lead at the study level.
* Lead the end-to-end clinical development strategy for an EPU program and contribute to later stages as needed. 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 RIIRU/GSK review boards and protocol review boards.
* Evaluate business development opportunities clinically.
* Stay informed of advances in hepatology research, trial methodologies, regulatory space, and competitive environment to maintain GSK’s competitive edge. Identify transformational opportunities where projects offer significant patient benefits.
* Gather and integrate inputs from scientific, clinical, commercial, regulatory groups to contribute to clinical components of the Medicine Profile. Contribute to solving study and clinical development plan challenges.
* Contribute to implementing strategic initiatives and organizational initiatives in the EPU.
* Demonstrate ability to influence others at project, departmental, and inter-departmental levels as appropriate.
* Influencing and inspiring others, managing conflict
* Able to inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated.
* Experience in managing conflicts effectively and independently, negotiating mutually acceptable solutions.
* Influence outcomes through strong communication, trust-building, and tailoring messages to the audience.
* Enterprise mindset and navigating ambiguity
* Demonstrated flexibility in changing environments, able to analyze incomplete information, identify risks, and make informed decisions.
* Collaborate across the matrix, integrating cross-functional knowledge into decision-making and balancing team objectives with wider business goals.
* Embrace challenges as opportunities for creativity and use new learning and digital tools to drive innovation.
* Proactively generate ideas for improvement and foster an environment where others can contribute ideas.
Why you? Basic Qualifications:
* PhD or PharmD (or equivalent) with 1-3 years of postgraduate experience.
* Minimum of 3 years of experience in clinical research and development (including postgrad experience).
* Knowledge of and experience in translational studies, including generation and analysis of human translational data and preclinical experiments in relevant models.
* Robust knowledge of hepatology 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.
Preferred Qualifications:
* Medical Degree preferred
* Board certified/eligible in hepatology
* General internal medicine preferred for MDs or alternative experience in the relevant disease area
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, focusing on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We focus on delivering innovation in specialty medicines and vaccines to impact health at scale.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, pregnancy, gender identity or expression, parental status, national origin, age, disability, genetic information, military status or any basis prohibited by law. We support an agile working culture and invite discussions about flexible arrangements with the hiring team.
For adjustments to the process, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available 8.30am to 12.00 noon Monday to Friday; times may vary on bank holidays. If your inquiry is not about adjustments, please refer to the UK Recruitment FAQ guide linked on the Careers page.
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