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About the Role
GSK is seeking an experienced Medical Director for the role of Medical Director Clinical Development- Hepatology. This role is key for identifying next-generation targets for liver disease and progressing assets into the clinic. You will provide medical and scientific expertise to clinical and translational studies, assess therapeutic potential of novel mechanisms, and collaborate on target validation programs. The role involves cross-functional collaboration to develop and execute clinical development plans and contribute to foundational and real-world data, as well as translational and biomarker capabilities.
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 to contribute to vital deliverables including early medicine profile, target validation, translational plans, and candidate selection.
- Design clinical development plans, study protocols and associated documents across all phases of development, reflecting internal and external stakeholder input.
- 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 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 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.
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
- 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
Skills
- Clinical Development
- Communication
- Drug Regulatory Affairs
- Evidence Based Decision Making
- Good Clinical Practice (GCP)
- Influencing Without Authority
- Learning Agility
- People Management
- Project Management
- Scientific Presentations
- Strategic Thinking
Location
- Stevenage, UK
- Cambridge, UK
Work Type
- Hybrid
Experience Level
- Experienced
Education Level
- Medical Degree
- Postgraduate clinical training, clinical residency or specialty training in Internal Medicine, Pathology, etc.
- Advanced specialty training, fellowship or country-equivalent higher-level qualification in Hepatology (or Gastroenterology)
Salary/Compensations
- $222,750 to $371,250 (Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA)
- $202,500 to $337,500 (Other US locations)
Benefits
- Annual bonus
- Eligibility to participate in share-based long-term incentive program
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
About the Company
- 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, as a successful, growing company where people can thrive.
- We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
- We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
- People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.
- Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
- We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Equal Opportunity
- 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 (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.