Medical Director, Clinical Development, Hepatology

WIB-Pittsburgh; Waltham (MA); Hybride; USD 223 000 - 371 000; Plein temps

Avantages offerts par ce poste

Health care

Retirement benefits

Annual bonus

Paid holidays

Résumé du poste

GSK seeks a Medical Director, Clinical Development, Hepatology to provide clinical and scientific leadership across hepatology assets in a hybrid work model. You will design and oversee development plans, lead clinical study execution, ensure safety oversight, and engage with regulators and external partners to drive successful regulatory submissions.

The role supports RIIRU and requires medical expertise, regulatory knowledge, and strong leadership within a cross-functional team environment.

Qualifications

• Medical degree with board qualification/registration in Internal Medicine or Primary Care is required.
• Experience in pharmaceutical clinical development and regulatory expectations.
• Leadership of matrix teams and collaboration across interfaces.

Responsabilités

• Provide clinical and scientific insights to hepatology assets throughout development.
• Lead study design and clinical development plans across stages.
• Oversee safety monitoring and regulatory interactions for assigned studies.
• Lead or participate in regulatory submissions and investor/partner communications.
• Engage with regulators, payors, and investigators to drive development timelines.

Connaissances

Analytical Thinking

Clinical Research

Leadership

Strategic Thinking

Influencing Without Authority

Formation

Medical degree

Hepatology board certification

Description du poste

Medical Director, Clinical Development, Hepatology

Location: Waltham, Massachusetts, United States (on-site)

Description

For candidates seeking to be located at our 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.

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

Position Summary

A Medical Director, Clinical Development, Hepatology is sought to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on liver diseases. You will work within project teams to plan, execute, and deliver clinical development activities up to and including registrational studies. You will report to the Clinical Development Lead. This role is pivotal in driving GSK's mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency.

About RIIRU

The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two-fold. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK-internal partnerships (Research Technologies).

Working Model

This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

Responsibilities

• Contribute to project team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to support vital deliverables including the Target Product Profile (TPP), clinical development plan (CDP), study protocols, and integrated evidence strategy (IES) and planning.
• Provide effective support to the development and execution of the IES, including oversight of R&D evidence generation activities to ensure patient safety and study delivery.
• Design and execute clinical development plans across advanced stages of development, reflecting internal and external stakeholder input (ie patients, evidence generation, regulators, payors, pharmacovigilance, etc).
• Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols, amendments, investigator brochures, clinical study reports etc.
• Input to, and may lead, 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. If physician, accountability for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.
• Act as clinical lead for a clinical study, taking a key role on the Study Leadership Team (SLT) and serve as clinical point of contact for a clinical study on the Clinical Matrix Team (CMT), across the internal matrix and a broad range of external experts (e.g., regulators, payors, CROs, consultants, investigators).
• Make significant contributions to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
• Evaluate specific business development activities, including due diligence and contributes to the implementation and embedding of strategic/organizational initiatives in Clinical Development, adopting innovative methodologies and processes including digital tools and technology.
• Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK's competitive edge.

Additional Responsibilities

• Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions.
• 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.
• Embrace challenge as an opportunity, proactively generating ideas for innovative improvement and promoting an environment for others to be creative.
• Manage conflicts effectively and independently, negotiating mutually acceptable solutions.
• Analyze, interpret and critically evaluate data, information and digital content to interpret complex information, anticipate obstacles and identify potential solutions.
• Consistently achieve 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.

Basic Qualifications

• Medical degree
• Clinical medical specialty training with board qualification/registration in Internal Medicine or Primary Care / Family Medicine.
• Completion of a full clinical residency program leading to board qualification or certification.
• Experience working in the pharmaceutical industry in clinical drug development, with understanding of clinical trial execution from concept to publication.
• Direct experience with in-stream medical oversight activities during trial conduct.
• Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.
• Understanding of clinical research methodology and biostatistical principles to support innovative and efficient clinical trial design and data‑driven decision rules.

Preferred Qualifications

• Medical degree plus completion of advanced clinical specialty training with board qualification/registration in Hepatology (or equivalent higher specialty training).
• Familiarity or experience in MASH or ALD drug development, disease biology, therapeutic targets, and current/future treatment landscape.
• Clinical research experience in hepatology, including clinical development planning and interventional study design.
• Experience with site‑facing interactions and/or activities supporting medical affairs, patient advocacy groups, or external organizations.
• Demonstrated ability to lead line or matrix teams, with a strong reputation for inspiring and motivating high performance.
• Experience engaging with regulators, payors, and prescribers in relevant markets.
• Experience integrating genetic data to inform clinical protocols.
• Proven ability to apply statistical and data visualization methods to interpret complex information, draw accurate conclusions, and support decision‑making.
• Experience using new digital tools and learning technologies to drive innovation.

Skills

Analytical Thinking, Business Acumen, Change Management, Clinical Research, Clinical Trial Designs, Communication, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Risk Management, Strategic Thinking

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $222,750 to $371,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Job ID: 86317478

GSK

Websitewww.gsk.com US Headquarters: Philadelphia, PA Size:10000+ employees Founded: 1830 Type: Company - Public (GSK) Industry: Biotech & Pharmaceuticals Revenue: $10+ billion (USD) per year Video: https://youtu.be/RBdgq5VTQmM We are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We also have a significant global presence with commercial operations in more than 150 countries, a netwo...