GlaxoSmithKline
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 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\' 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 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 Clinical Management Team on an EPU program. Serves as a clinical point of contact for an asset 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 and comprehensive translational and clinical development plans. Act as Clinical Lead at study level.
Lead 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 or clinical study 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/or Protocol Review Board.
Assess and evaluate business development opportunities.
Stay informed of advancements in hepatology research, trial methodologies, regulatory space to maintain GSK\'s competitive edge. Identify transformational opportunities where projects offer significant patient benefit.
Integrate inputs from across disciplines to contribute to clinical components of the Medicine Profile and support solving study and development plan challenges.
Contribute to the implementation and embedding of strategic initiatives within the EPU and demonstrate the ability to influence others at multiple levels.
Influencing and Navigating
Able to inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued.
Experience in managing conflicts and negotiating mutually acceptable solutions.
Strong influencing skills, understanding perspectives, building trust, and communicating effectively to gain support.
Enterprise Mindset
Demonstrated flexibility in changing environments, ability to analyse incomplete information, identify risks, and make informed decisions.
Demonstrated enterprise mindset with effective cross-functional collaboration and integration of knowledge into decision-making.
Openness to challenge, adoption of new learning and digital tools to foster innovation.
Proactively generates ideas for improvement and encourages others to do so.
Qualifications Required:
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 and hepatology research priorities; experience with global regulatory agencies and global clinical trials in hepatology; knowledge of GCP and ethical guidelines.
Preferred:
Medical Degree; Board certified/eligible in hepatology; general internal medicine experience for MDs or related disease area experience.
Why GSK GSK is an Equal Opportunity Employer. We are committed to an agile working culture and provide adjustments on request. See the full Equal Employment Opportunity statement and contact options for adjustments and inquiries in the original posting. This description retains legally required notices and broad company information.
GSK does not accept referrals from employment businesses/agencies without prior written authorization. All required disclosures related to US transparency and reporting will be followed as applicable.
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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\' 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 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 Clinical Management Team on an EPU program. Serves as a clinical point of contact for an asset 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 and comprehensive translational and clinical development plans. Act as Clinical Lead at study level.
Lead 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 or clinical study 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/or Protocol Review Board.
Assess and evaluate business development opportunities.
Stay informed of advancements in hepatology research, trial methodologies, regulatory space to maintain GSK\'s competitive edge. Identify transformational opportunities where projects offer significant patient benefit.
Integrate inputs from across disciplines to contribute to clinical components of the Medicine Profile and support solving study and development plan challenges.
Contribute to the implementation and embedding of strategic initiatives within the EPU and demonstrate the ability to influence others at multiple levels.
Influencing and Navigating
Able to inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued.
Experience in managing conflicts and negotiating mutually acceptable solutions.
Strong influencing skills, understanding perspectives, building trust, and communicating effectively to gain support.
Enterprise Mindset
Demonstrated flexibility in changing environments, ability to analyse incomplete information, identify risks, and make informed decisions.
Demonstrated enterprise mindset with effective cross-functional collaboration and integration of knowledge into decision-making.
Openness to challenge, adoption of new learning and digital tools to foster innovation.
Proactively generates ideas for improvement and encourages others to do so.
Qualifications Required:
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 and hepatology research priorities; experience with global regulatory agencies and global clinical trials in hepatology; knowledge of GCP and ethical guidelines.
Preferred:
Medical Degree; Board certified/eligible in hepatology; general internal medicine experience for MDs or related disease area experience.
Why GSK GSK is an Equal Opportunity Employer. We are committed to an agile working culture and provide adjustments on request. See the full Equal Employment Opportunity statement and contact options for adjustments and inquiries in the original posting. This description retains legally required notices and broad company information.
GSK does not accept referrals from employment businesses/agencies without prior written authorization. All required disclosures related to US transparency and reporting will be followed as applicable.
#J-18808-Ljbffr