Clinical Development Medical Director- Hepatology

GSK•Boston, MA

2d•$202,500 - $371,250•Hybrid

About The Position

GSK is seeking an experienced Medical Director for the role of Medical Director Clinical Development- Hepatology within GSK’s Respiratory, Immunology & Inflammation Research Unit. The role involves identifying next-generation targets for liver disease and progressing assets into clinical trials to demonstrate proof of concept. The Medical Director will provide medical and scientific expertise and leadership to clinical and translational studies, contribute to assessing the therapeutic potential of novel mechanisms and targets, and collaborate in the design of target validation programs. They will also identify and drive life-cycle expansion and innovative clinical development opportunities. The role requires cross-functional collaboration to develop and execute clinical development plans (CDPs) and contribute to foundational and real-world data, as well as translational and biomarker capabilities. The Respiratory, Immunology, and Inflammation Research Unit (RIIRU) focuses on leveraging science to identify novel treatments for organ dysfunction and disease, driving the end-to-end R&D journey from early discovery to late-stage advancement. The unit combines field-leading data sets, capabilities, and methods with extensive knowledge to innovate new medicines.

Requirements

Medical Degree
Completion of a formal postgraduate clinical training, clinical residency or specialty training in Internal Medicine, Pathology, etc.
Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation
Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks
Ability to apply clinical judgement to support study design, patient safety, and real-time medical decision-making within a structured clinical development framework
Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment
Strong scientific communication skills, with the ability to translate clinical data into clear insights for internal and external audiences

Nice To Haves

Completion of advanced specialty training, fellowship or country-equivalent higher-level qualification in Hepatology (or Gastroenterology) leading to recognition as a medical specialist through formal certification, board certification or country specific professional designation
Experience in pharmaceutical or biotechnology clinical development across early phase studies.
Clinical experience in hepatology and/or relevant therapeutic areas, with direct exposure to clinical research or drug development in industry or postgraduate work
Robust knowledge of liver disease research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
Knowledge of and experience in the execution of clinical and/or translational studies including generation and analysis of human translational data and conduct of preclinical biological experiments in relevant model systems.
Experience working with global regulatory agencies and managing global clinical trials in relevant disease area
Prior experience contributing to regulatory interactions (e.g., IND submissions, scientific advice, NDA/MAA filings)
Demonstrated experience engaging with Key External Experts (KEEs), investigators, and scientific collaborators in Liver Disease
Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards.
Experience in contributing to IND/CTA, NDA, BLA, or MAA submissions

Responsibilities

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 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.
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.
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 inter-departmental levels, as appropriate.
Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovative approaches to science and technical solutions.
Promote an environment for others to generate ideas for improvement and proactively drives innovation, beyond taking advantage of opportunities that arise.
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.
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.
Manage conflicts effectively and independently, negotiating mutually acceptable solutions.
Demonstrate 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.
Analyses, interprets and critically evaluates data, information and digital content to interpret complex information, anticipate obstacles and identify potential solutions.
Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions.