Associate Director - Clinical Development (Hepatology)

GSK; Camden Town; On-site; GBP 110,000 - 140,000; Full time

Job summary

GSK is seeking an Associate Director - Clinical Development to provide expert medical input at the study level for hepatology assets across Phase 1-4, leading protocol development, safety oversight, and medical monitoring within global teams.

The role requires an MD or equivalent and a strong track record in clinical development, GCP/ICH, and cross-functional collaboration to drive study decisions and regulatory deliverables.

Qualifications

• Clinical development experience in pharmaceutical/biotechnology or academic clinical research (including global interventional trials).
• Strong understanding of clinical development processes, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and relevant regulatory frameworks.

Responsibilities

• Medical monitoring and safety oversight of hepatology trials (Phase 1-4).
• Authoring and leading development of protocols and key documents (IB, ICF, CSRs).
• Design, conduct and interpretation of studies aligned with the Clinical Development Plan (CDP).
• Lead or co-lead development of protocols and amendments for hepatology assets (Phase 1-4).
• Provide medical input to eligibility criteria, endpoints and safety monitoring plans.
• Author or oversee the authorship of protocols, IBs, ICFs, CRFs, CSRs and regulatory documents.
• Serve as study medical monitor for hepatology trials, overseeing participant safety and data quality.
• Analyze and interpret emerging clinical data to generate study-level insights in hepatology.
• Lead or support preparation of clinical and regulatory documents for hepatology studies.
• Act as member of the Clinical Matrix Team and cross-functional study teams.
• Prepare scientific content for investigator meetings and site communications.
• Ensure adherence to ICH/GCP, GSK SOPs and regulatory frameworks.
• Identify issues and help develop mitigation and process improvements in hepatology development.
• Contribute to consistent ways of working and sharing best practices across Hepatology Clinical Development.

Skills

Agile Thinking

Clinical Development

Clinical Trial Designs

Decision Making

Fostering Collaboration

Influencing Without Authority

Leadership

Matrix Leadership

Mentorship

People Management

Project Management

Risk Management

Strategic Thinking

Teamwork

Time Management

Education

Medical degree (MD) or equivalent

Bachelor's degree in life sciences or related discipline

Job description

The Associate Director - Clinical Development provides scientific and medical expertise at the study-level across early-and late-phase hepatology assets. The role operates within cross-functional global study teams to deliver high-quality, timely data that inform asset and portfolio decisions in hepatology. The role is a senior contributor focused on:

• Medical monitoring and safety oversight of assigned hepatology clinical trials (Phase 1-4).
• Authoring and leading the development of protocols and other key study documents (e.g. Investigator's Brochure (IB), Informed Consent Form (ICF), & Clinical Study Report (CSRs).
• Supporting the design, conduct and interpretation of studies in alignment with the Clinical Development Plan (CDP)., Lead or co-lead development of clinical trial protocols and amendments for hepatology assets (Phase 1-4), ensuring scientific robustness, operational feasibility and alignment with CDP aims. Provide core medical input to eligibility criteria, endpoints and safety monitoring plans for hepatology populations (based on general hepatology clinical practice).
• Author or oversee authoring of protocols, protocol amendments, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), Clinical Study Reports (CSRs) and study-level regulatory documents. Ensure scientific accuracy, internal consistency and clarity across study documentation.
• Serve as study medical monitor (or co-monitor) for assigned hepatology trials, providing day-to-day medical oversight of participant safety, protocol adherence and data quality. Participate in safety data review, signal detection and risk-benefit assessments, with timely escalation and documentation of safety-related decisions.
• Analyse and interpret emerging clinical data (efficacy, safety and relevant biomarkers) to generate study-level insights in hepatology indications. Integrate internal and external data (e.g. literature, competitor data) to support robust decision-making at study and programme level.
• Lead or support preparation of clinical and regulatory documents (e.g. CSRs, briefing packages, responses to regulatory queries) for hepatology studies. Ensure alignment with GCP, ICH guidelines and applicable global/local regulatory frameworks.
• Act as a member of the Clinical Matrix Team (CMT) and study-level cross-functional teams, collaborating with Global Study Management, Development Operations, Biostatistics, Safety, Regulatory and Medical Affairs. Provide expert hepatology input into operational documents (e.g. Safety Management Plan, protocol deviation management plan, training materials) and study delivery plans.
• Prepare and deliver scientific content for investigator meetings and site communications; respond to medical questions and represent the hepatology programme as a subject-matter expert.
• Ensure assigned studies are conducted in accordance with ICH/GCP, GSK SOPs and all applicable laws and regulations, maintaining inspection readiness and robust documentation.
• Identify scientific or operational issues at the study level and support development of mitigation approaches and process improvements in hepatology clinical development.
• Contribute to implementation of consistent ways of working and sharing of best practice across Hepatology Clinical Development.
• Provide informal coaching and guidance to less experienced clinical scientists and study physicians on protocol development, medical monitoring and documentation standards (no formal line management).

At GSK we are looking for a capable medical professional to join our Hepatology Clinical Development department. Please note that the successful applicant must have a Medical degree (MD or equivalent) for this role. Medical degree: MD or equivalent is required, with clinical training and/or significant experience in hepatology or closely related liver disease disciplines (based on general clinical-development practice).

Bachelor's degree in life sciences or related discipline (underpinning scientific training).

Preferred attributes and experience

• Clinical development experience in pharmaceutical/biotechnology or academic clinical research (including global interventional trials).
• Strong understanding of clinical development processes, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and relevant regulatory frameworks.

Skills

Skills: Agile Thinking, Clinical Development, Clinical Trial Designs, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Project Management, Risk Management, Strategic Thinking, Teamwork, Time Management.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting- edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more - our approach to R&D: https://www.gsk.com/en-gb/innovation, 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, 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.

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. 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.

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