Medical Director, Clinical Development, Immunology

We are seeking a Medical Director to support the Clinical Development Lead (CDL) and clinical team in planning and executing a clinical program focused on food allergy, including late-stage studies in IgE mediated allergic disease. This role offers the opportunity to support multiple indications as part of the program's life cycle management plans and contribute to a dynamic, collaborative clinical research community.

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. RIIRU's remit is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approval. This goal is enabled through strategic external partnerships (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics) and GSK-internal collaborations (Research Technologies).

This role requires an on-site office presence (minimum of two days a week) at one of GSK's US (PA or MA) or UK (Stevenage or London HQ) sites.

Responsibilities

• Support the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for asset(s) in development.
• Ensure alignment with project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP.
• Generate data and evidence to determine a medicine's potential efficacy, safety profile, key areas of product differentiation, and value to patients.
• Provide oversight of evidence generation activities to assure patient safety and study delivery.
• Enable robust protocol design, including selection of clinical endpoints, patient populations, and participant monitoring strategy.
• Collaborate with Clinical Operations and Biostatistics to deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
• Perform active medical monitoring and medical data review of ongoing studies, including:
  • Lead, coordinate activities, and present at IDMCs, adjudication committees, and ongoing routine safety reviews.
  • Interpret and present clinical data for clinical study reports and publications.
  • Oversee and train study teams on protocol-related activities in collaboration with matrix study team members.
• Develop and maintain relationships with program counterparts, including Commercial, Research, Regulatory, Clinical Operations, and Statistics.
• Interface with and influence a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) to deliver clinical programs and align with business strategy.
• Gather and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to clinical components of the Medicine Profile.
• Contribute to regulatory interactions, including briefing documents, presentations, and addressing questions and responses.
• Serve as a clinical representative for senior management and senior-level matrix teams, both internally and externally, for an asset in development.
• Support the implementation and embedding of strategic initiatives within RIIRU.
• Mentor and coach RIIRU staff to support technical and leadership development.
• Contribute to enterprise efforts to streamline and grow efficiencies for the business unit.

Requirements

• Medical degree and clinical medical specialty training board qualification/registration in Internal Medicine or Primary Care/Family Medicine with specialized experience in IgE mediated disease and food allergy.
• Experience in clinical drug development, including clinical trial execution from concept to publication.
• Clinical research experience in food allergy, including clinical development planning and interventional study design.
• Experience with in-stream medical oversight activities during trial conduct.
• Experience with ICH guidelines, FDA requirements, and global regulatory expectations.
• Experience in clinical research methodology and biostatistical principles to support innovative and efficient clinical trial design and data-driven decision rules.

Preferred Qualifications

• Familiarity or experience in Chronic Urticaria and IgE mediated disease biology, therapeutic targets, and current/future treatment landscape.
• 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
• Change Management
• Clinical Research
• Clinical Trial Designs
• Communication
• Decision Making
• Fostering Collaboration
• Influencing Without Authority
• Leadership
• Matrix Leadership
• People Management
• Risk Management
• Strategic Thinking
• Strategy Development
• Teamwork

Pay

For candidates based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for this position ranges from $222,750 to $371,250. The US salary ranges consider factors such as work location, skills, experience, education level, and market rate for the role. This position also offers an annual bonus and eligibility to participate in a share-based long-term incentive program.

Benefits

• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays, vacation, and paid caregiver/parental and medical leave.

For more details, visit the GSK US Benefits Summary.