Associate Director - Clinical Development (Hepatology)

1054 GlaxoSmithKline Services Unlimited; Cambridge; Sur place; GBP 150 000 - 200 000; Plein temps

Résumé du poste

GlaxoSmithKline plc is seeking an Associate Director – Clinical Development to provide medical and scientific leadership for hepatology trials (Ph1–Ph4). You will oversee protocol development, safety monitoring, and regulatory documentation while ensuring alignment with the Clinical Development Plan.

The role involves cross-functional collaboration with Global Study Management, Biostatistics, Safety, and Regulatory teams, and requires MD or equivalent with hepatology experience.

Qualifications

• MD or equivalent medical degree required with hepatology or related liver disease exposure.
• Experience in clinical development of pharma/biotech or academic trials.
• Strong knowledge of GCP, ICH guidelines, and regulatory frameworks.

Responsabilités

• Lead or co-lead hepatology protocol development and amendments (Ph1–Ph4).
• Provide core medical input for eligibility, endpoints and safety monitoring.
• Author or oversee IBs, ICFs, CRFs and CSRs for hepatology studies.
• Ensure accuracy and consistency across study documentation.
• Serve as study medical monitor with day-to-day safety oversight.
• Contribute to safety reviews, signal detection, risk-benefit assessments.

Connaissances

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

Formation

MD or equivalent medical degree

Bachelor’s degree in life sciences or related discipline

Description du poste

At GSK we are looking for a capable medical professional to join our Hepatology Clinical Development department. 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).

Key Responsibilities (include..):

• 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).

Location:

GSK HQ London, Stevenage, or Ware R&D. Please Note: If the successful applicant is based at Stevenage site: This role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge UK, in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

Qualification:

Please note that the successful applicant must have a Medical degree (MD or equivalent) for this role.

About GSK:

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/

APPLICATION CLOSING DATE – Monday 16th of November 2026 (COB).

Basic Qualifications:

• 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:

• 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

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, 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.

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. However, we have created a Recruitment FAQ guide.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.