Job description

Site Name: USA - Pennsylvania - Upper Providence, GSK HQ, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham

Posted Date: Feb 11 2025

Position Overview: We are seeking a dynamic and experienced Executive Director Clinical Lead for Immunology to lead our clinical development programs within the Immunology therapeutic area. This role will involve strategic oversight, leadership, and management of programmes and clinical trials, ensuring scientific integrity and adherence to regulatory requirements.

Key Responsibilities:

Provide strategic leadership and direction for the design, execution, and management to clinical development plans and clinical trials in Immunology.

Lead the end-to-end clinical development strategy for a drug or program. Manage specific clinical development plans for product(s) and/or indication(s) in specific therapy/disease areas.

Contribute to the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for an asset in development. Be accountable for the clinical components of the Target Medicine Profile (TMP).

Oversee the development and implementation of clinical trial protocols, ensuring alignment with regulatory requirements and GSK’s scientific standards.

Collaborate with cross-functional teams, including research, regulatory affairs, medical affairs, and commercial teams, to ensure cohesive and comprehensive clinical development plans.

Serve as the primary point of contact for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.

Ensure the integrity, safety, and efficacy of clinical trials through rigorous monitoring, data analysis, and risk management.

Lead and mentor clinical professionals, fostering a culture of innovation, collaboration, and excellence.

Manage senior clinical scientists and physician scientists (direct reports) working on Immunology assets.

Stay abreast of advancements in Rheumatology research, clinical trial methodologies, and regulatory changes to maintain GSK’s competitive edge.

Contribute to above asset Immunology strategy.

Assist in clinical evaluation of business development opportunities.

Represent GSK in scientific meetings, conferences, and industry forums to advance our Immunology clinical research initiatives.

An on-site office presence (minimum of two days a week) is required in one of GSK’s UK (London - New Oxford Street or Stevenage) or US (PA or MA) offices.

Job description

Site Name: London The Stanley Building

Posted Date: Feb 13 2025

At GSK.ai we see a world in which advanced applications of machine learning and AI will allow us to develop novel therapies to existing diseases and to quickly respond to emerging or changing diseases with personalized drugs, driving better outcomes at reduced cost with fewer side effects. It is an ambitious vision that will require the development of products and solutions at the cutting edge of machine learning and AI. If that excites you, we'd love to chat. 

 

Our AI/ML Engineering organization is horizontally positioned to support GSK.ai product delivery; we design, build, and maintain key platforms and services in conjunction with our Machine Learning teams and the Onyx Platform organization. The products we build enable researchers to leverage advanced AI to reduce the risk of advancing drugs through the pipeline. Our UK-based team will be particularly responsible for supporting high priority objectives in the biomedical and clinical domains, as well as advancing our LLM and Agents strategic roadmap. This is a high impact organization that is critical for our long-term success; we’re looking for an outstanding leader to set the vision and strategy, execute a fit-for-purpose hiring strategy, and drive the product line end-to-end.

 

As a Director of Engineering, you will be expected to perform in settings of high visibility and rapid growth. Competitive candidates will have a track record of high output leadership as well as experience shipping cloud software and data products at scale. Candidates with experience shipping ML platforms will be very competitive. Understanding of genetics and biology and previous experience in the Pharma industry is a plus, but not required outside of a willingness to learn. Equally important will be excellent communication, interpersonal and organizational skills, and the ability to represent and transmit the values and principles of our AIML team. 

 

The AI/ML team is built on the principles of ownership, accountability, continuous development, and collaboration. We hire for the long term, and we're motivated to make this a great place to work. Our leaders will be committed to your career and development from day one. 

 

As a Director of AI/ML Engineering, you will: 

Lead a software engineering team responsible for deploying production services and platforms.

Manage complex, multi-quarter, cross-functional projects spanning partners and stakeholders in AI/ML, research science, and laboratories.

Be a standard bearer for production and software engineering best practices within the organization.

Develop plans to meet requirements, organize a team capable of executing the plans, and lead and track delivery. 

Drive an interview process to enable team growth adhering to diversity and inclusion requirements.

Maintain a safe and inclusive team environment in which people thrive.

Operate in a transparent way, communicating clearly and accurately to leadership and the broader organization.

Develop a high-performing team through coaching, feedback and ensuring opportunities for growth.

 

Job description

Site Name: USA - Massachusetts - Waltham, Rockville Vaccines, UK – London – New Oxford Street, Upper Providence, Wavre

Posted Date: Nov 20 2024

Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.

 

Responsibilities and Accountabilities (include expected deliverables, managerial and leadership responsibilities and performance standards):

 

Accountable to GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. In this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with Precision Medicine/Digital Health partners and regulatory agencies. 

In addition, this role will serve to build and maintain the team’s book of work, consisting of 

 

This role works closely with members of the Regulatory Operations, Precision Medicine, and Unit Digital Health teams. Lead or participate in interactions with local / regional regulatory authorities.

 

In performing the role, the job holder will be responsible for:

Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. Leading regulatory interactions and the review processes for GSK.

Ensuring compliance with regulatory requirements at all stages of product life from C2MD.

Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities.

Capable of providing assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules. 

 

Competencies and Capabilities (include key high-performance behaviors). Challenges and questions ways of working to seek improved process.

Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.

 

Job description

Site Name: UK - Hertfordshire - Stevenage, UK – London – New Oxford Street

Posted Date: Nov 15 2024

Please note this role requires to be based in a UK GSK site for a minimum of 2 days per week.

Are you a Nephrology Physician looking to partner with world renowned experts - bringing cutting edge science and technology to aid in the development of novel treatments for patients? This Director role in our Respiratory & Immunology Research Unit (RIRU) may be of interest.

Our RIRU is committed to leading the way in Respiratory & Immunology Clinical Research, harnessing the power of the immune system, patient biology and predictive technologies. We are focused on bridging the gap between research and clinical practice to maximise pipeline value and enhance patient lives globally.

A Clinical Development Director - Nephrology is sought to provide clinical and scientific insights to the Nephrology franchise including emerging indications and adjacencies. You will work within project teams to plan and assure delivery of clinical research and development activities. You will work closely with research members to define the best clinical indication for a target an integrates inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Early Medicine Profile, Target Validation plans, and Candidate Selection. You will work with early and late development teams to plan clinical development programs and facilitate close collaboration between diverse groups within the Respiratory & Inflammation Research Unit.

In October 2024, GSK announced a five-year collaboration with Cambridge University in Kidney and Respiratory disease - more details on which can be found here: GSK and Cambridge University announce new five-year collaboration in kidney and respiratory disease | GSK

The responsibilities of the Clinical Development Director - Nephrology include (but are not limited to) several key areas:

Designing and leading, as appropriate, clinical development protocols/studies/programs in Nephrology across all phases of development, as required by business imperatives as part of clinical and medicine development matrix teams.

Clinical development strategy including study Ph1-2/3 design

Providing clinical expert input into regulatory documentation and leading regulatory interactions from clinical perspective for their studies/ indications, as appropriate

Working closely with Research Unit members to define prioritized clinical indications for early targets and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory and stats) to contribute to the Medicine Profile, Target Validation, Translational Plans, Candidate Selection., clinical development plan and integrated evidence plan.

Design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development

and/or accountability for design and delivery of the full development clinical development plan that effectively demonstrates benefit-risk and leads to a successful submission to regulators, payors etc.

Leading the integrated evidence planning to address the needs of regulators, payors, and patients.

Participating/ leading the clinical Team (CT) (or equivalent cross-functional clinical team) and Integrated Evidence Team (IET)

Engaging external academic and clinical experts to enhance quality and delivery of clinical programs/ studies.

Providing clinical input into presentations, supporting documentation for and participation in the governance bodies presentations, as requested.

Accountability for escalation of clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate

Clinical input to regulatory documentation to support the desired indication (e.g., IB, IMPD)

Responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees

Accountability for regulatory reporting requirements including Development Safety Update Reports (DSUR’s) and IB updates

Accountable for incorporating patient perspective in the design and conduct of clinical studies

Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy (i.e., manufacturing, formulation, etc.) 

Providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety 

Leadership

Experience in drug development and/or translational medicine, preferably with industry experience.

You will be expected to work across multiple projects and be independently accountable for your own projects.

Provide input into disease area strategy and be capable of executing this strategy based on your own expertise and that gained from your network.

Play a leadership role in – medical governance initiatives in R&D (e.g., safety panel or governance board) – discovery/development policy, processes, or guidelines, as requested by the business– or in professional networks in/outside of GSK.

You will be able to input into relevant business development activities representing, as requested.

Mentoring and coaching other members of Clinical Research and Early Programs Immunology – applying extensive knowledge of clinical development to more than one research unit/disease area.

External networking with academia/pharma, bringing expertise back to GSK.

You will be able to anticipate, communicate, and suggest solutions on trends/events outside GSK that affect our business direction – utilizing command of the drug discovery and development process to influence a culture of continuous improvement.

Job description

Site Name: UK - Hertfordshire - Stevenage, UK – London – New Oxford Street

Posted Date: Nov 15 2024

Please note this role requires to be based in a UK GSK site for a minimum of 2 days per week.

Are you a Nephrology Physician looking to partner with world renowned experts - bringing cutting edge science and technology to aid in the development of novel treatments for patients? This Director role in our Respiratory & Immunology Research Unit (RIRU) may be of interest.

Our RIRU is committed to leading the way in Respiratory & Immunology Clinical Research, harnessing the power of the immune system, patient biology and predictive technologies. We are focused on bridging the gap between research and clinical practice to maximise pipeline value and enhance patient lives globally.

A Clinical Development Director - Nephrology is sought to provide clinical and scientific insights to the Nephrology franchise including emerging indications and adjacencies. You will work within project teams to plan and assure delivery of clinical research and development activities. You will work closely with research members to define the best clinical indication for a target an integrates inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Early Medicine Profile, Target Validation plans, and Candidate Selection. You will work with early and late development teams to plan clinical development programs and facilitate close collaboration between diverse groups within the Respiratory & Inflammation Research Unit.

In October 2024, GSK announced a five-year collaboration with Cambridge University in Kidney and Respiratory disease - more details on which can be found here: GSK and Cambridge University announce new five-year collaboration in kidney and respiratory disease | GSK

The responsibilities of the Clinical Development Director - Nephrology include (but are not limited to) several key areas:

Designing and leading, as appropriate, clinical development protocols/studies/programs in Nephrology across all phases of development, as required by business imperatives as part of clinical and medicine development matrix teams.

Clinical development strategy including study Ph1-2/3 design

Providing clinical expert input into regulatory documentation and leading regulatory interactions from clinical perspective for their studies/ indications, as appropriate

Working closely with Research Unit members to define prioritized clinical indications for early targets and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory and stats) to contribute to the Medicine Profile, Target Validation, Translational Plans, Candidate Selection., clinical development plan and integrated evidence plan.

Design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development

and/or accountability for design and delivery of the full development clinical development plan that effectively demonstrates benefit-risk and leads to a successful submission to regulators, payors etc.

Leading the integrated evidence planning to address the needs of regulators, payors, and patients.

Participating/ leading the clinical Team (CT) (or equivalent cross-functional clinical team) and Integrated Evidence Team (IET)

Engaging external academic and clinical experts to enhance quality and delivery of clinical programs/ studies.

Providing clinical input into presentations, supporting documentation for and participation in the governance bodies presentations, as requested.

Accountability for escalation of clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate

Clinical input to regulatory documentation to support the desired indication (e.g., IB, IMPD)

Responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees

Accountability for regulatory reporting requirements including Development Safety Update Reports (DSUR’s) and IB updates

Accountable for incorporating patient perspective in the design and conduct of clinical studies

Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy (i.e., manufacturing, formulation, etc.) 

Providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety 

Leadership

Experience in drug development and/or translational medicine, preferably with industry experience.

You will be expected to work across multiple projects and be independently accountable for your own projects.

Provide input into disease area strategy and be capable of executing this strategy based on your own expertise and that gained from your network.

Play a leadership role in – medical governance initiatives in R&D (e.g., safety panel or governance board) – discovery/development policy, processes, or guidelines, as requested by the business– or in professional networks in/outside of GSK.

You will be able to input into relevant business development activities representing, as requested.

Mentoring and coaching other members of Clinical Research and Early Programs Immunology – applying extensive knowledge of clinical development to more than one research unit/disease area.

External networking with academia/pharma, bringing expertise back to GSK.

You will be able to anticipate, communicate, and suggest solutions on trends/events outside GSK that affect our business direction – utilizing command of the drug discovery and development process to influence a culture of continuous improvement.

Job description

Site Name: Philadelphia Walnut Street, Stevenage

Posted Date: Feb 20 2025

The Interventional Study Scientist Medical Director will lead the scientific design of interventional clinical studies, medical governance, and interpretation of results within the Medical Affairs organization (non-regulatory label-directed programs) for assigned asset(s)/indication(s). This role will partner closely with the GML and GMT and is the single point accountability for translating the evidence strategy set by the GMT into appropriate interventional studies. The study designed is expected to fulfill a strategic objective of the clinical development and integrated evidence plan. This role is pivotal in shaping data generation strategies and ensuring clinical trials are conducted with the highest standards of quality, ethics, and efficiency. The successful candidate will have deep expertise in industry-sponsored clinical research, global medical affairs, commercial acumen, and cross-functional team leadership. They will oversee multiple projects independently and may be responsible for study development and implementation across an entire therapeutic area.

Key Responsibilities:

Strategic Leadership:

Translating the strategic vision for the therapeutic area and asset set forth by the GMT into Medical Affairs interventional studies and aligning them with GSK’s overarching goals.

Lead the design of interventional medical affairs clinical trials from Phase I through Phase IV including integrated input from internal/external experts, thought leaders and patients.

Ensure alignment of interventional study strategies with regulatory requirements and industry best practices.

Ensure that study objectives are consistent with decision criteria in the clinical development plan and integrated evidence plan.

Ensure appropriate incorporation of design of study into protocol.

Present the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct.

Scientific oversight for the study:

Oversee benefit-risk of the study.

Ensure study analysis plan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results.

Review clinical data and study conduct to assure patient safety and scientific integrity. This would include ongoing review of protocol deviations and implementation of remedial plans.

Oversee medical governance for the study including medical monitoring.

Outputs for the study:

Interpretation of study data to create the scientific content of Clinical Study Report (CSR).

Preparation of study results for abstracts, posters and presentations for scientific meetings, congresses, external journal publications.

Preparation of clinical content of regulatory documents and interaction with global regulatory authorities for the study (if needed).

Provides input into and reviews other relevant study document including the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM).

Provides scientific content for other study specific documentation (e.g. slides for site/monitor/investigator training).

Collaborate with cross-functional teams to ensure seamless execution and delivery of clinical programs, in particular the clinical development operations and biostatistics teams, as well as third party vendors.

Monitor and manage study progress, ensuring compliance with protocols, regulatory requirements, and GSK standards.

Team Leadership:

Foster a collaborative and innovative culture within the interventional studies team.

Provide guidance and support for professional development and career growth of team members.

Partner with the Study Delivery Lead and Project Manager (in Clinical Operations) to ensure optimal delivery of the study.

Maintain close collaboration with various functions including drug safety, regulatory affairs, biostats, TAs (GMLs and GMT) in medical affairs and clinical trial operations at the study level.

Regulatory and Compliance:

Ensure that all interventional studies are conducted in accordance with GCP, and other relevant regulatory guidelines.

Maintain oversight of all regulatory submissions and interactions related to interventional studies.

Ensure robust quality control and assurance processes are in place for all clinical trials.

Stakeholder Engagement:

Serve as the primary point of contact for internal and external stakeholders regarding the study.

Collaborate with key opinion leaders, investigators, and external partners to enhance study design and execution.

Communicate study progress, challenges, and outcomes to senior leadership, the GML/GMT, and other relevant stakeholders.

Innovation and Continuous Improvement:

Identify and implement innovative approaches to improve the efficiency and effectiveness of interventional studies.

Stay abreast of industry trends, emerging technologies, and new methodologies in clinical research. 

Promote a culture of continuous improvement within the interventional studies team. 

Job description

Site Name: Home Worker - GBR, GSK HQ, UK - Hertfordshire - Stevenage

Posted Date: Mar 11 2025

Job Purpose

The Team Lead is responsible for developing and delivering a robust audit program within the scope of R&D. This position will develop methods to effectively and efficiently design and deliver the audit strategy. This position will manage a team responsible for conducting all types of independent audits of External Service Providers and Internal GSK processes globally. The purpose is to ensure compliance with relevant international regulatory agency regulations/guidelines, GSK policies/procedures, including the Internal Control Framework and accepted principles. The team Lead will work with the other roles in R&D Quality and Risk Management across the matrix, build solid working relationships with the stakeholders and maintain knowledge of regulatory frameworks and requirementsKey Responsibilities

Team and Performance Management:

Manage and develop a team of Auditors, ensuring the delivery of a risk-based audit program that meets regulatory authority requirements leveraging different audit types.

Recruit, train, and coach staff, addressing their development needs and ensuring their performance aligns with organizational goals.

Oversee administrative aspects such as budget and personnel administration.

 

Audit Program Delivery:

Provide strategic input in the development, management, and implementation of strategies and initiatives, policies and procedures to support the audit program.

Lead the planning, coordination, and execution of audits across central processes, Local Operating Companies and External Third Parties.

Provide strategic vision and leadership oversight to sponsor or lead cross functional projects.

Ensure process and risk-based audit approach and clear documentation of audit findings.

Monitor appropriate metrics to oversee critical audit activities.

· 

Compliance and Quality Assurance:

Generate and interpret metrics and trend reports to identify trends and opportunities for improvements across the business.

Collaborate with stakeholders to interpret international regulations and establish compliance standards.

Provide expert advice on complex compliance issue, quality improvement initiatives, and risk assessments.

Represent GSK at global regulatory inspections.

· 

Stakeholder Engagement:

Build and maintain beneficial working relationships with internal and external customers and across the Matrix in R&D Quality and Risk Management.

Accurately and clearly communicate about audit, inspection, and investigation trends. Educate, guide, and influence stakeholders on best quality and compliance practices, especially in areas of identified responsibility.

Proactively communicate audit outcomes, findings and complex issues to VPs and SVPs, working with them to remediate identified issues.

· 

Regulatory and Industry Awareness:

Maintain an up-to-date and in-depth knowledge of national and international legislation and guidelines.

Analyse external regulatory intelligence and influence internal change as required. 

Develop, maintain and leverage a network of external contacts with other quality and compliance industry bodies

Job description

Site Name: UK – London – New Oxford Street, Aranda, Durham Blackwell Street, Karachi Sky Tower, Marburg - Office, Munich, Saint-Amand-les-Eaux, Siena, Singapore - Tuas, Tres Cantos, USA - Pennsylvania - Philadelphia, Wavre

Posted Date: Mar 19 2025

Senior Director, Digital Quality Solutions

The role can be done from any location in the world that is close to a GSK locationThe posting period will end on the 6th of April in 2025

Job purpose: 

This role will act as the Global Leader for defining and delivering the Quality strategy and roadmap for Digital and Analytics, development & deployment of solutions, and ensuring a sustainable operating model and process is in place to effectively maintain, sustain and continuously improve deployed solutions. This role will drive Digital transformation within the Quality Function, in line with GSK’s ambition of quality as a competitive advantage.

Key responsibilities include, but are not limited to the following:

Accountable for defining and delivering the Quality strategy for Digital and Analytics. Manages stakeholder network to ensure alignment and connectivity across key functions and alignment to Functional strategies

Ensures effective ownership of digital and analytics global business process:

Develop and manage digital intake process, roadmap and portfolio prioritization with value realization tracking. Work across Quality teams / processes to identify business cases for automation, artificial intelligence, digital adoption tools, etc.

Develop, maintain/sustain and continuously improve the process for Digital solution development and business as usual (BAU) for Quality

Drive the digital governance model in coordination with the overall Quality Systems & Data operating model and develop connections across GSC (e.g. Smart Manufacturing) and Enterprise teams & systems

Benchmark across industry to identify best in class processes and solutions

Act as SME for key digital regulations (new and changing) to ensure rapid adoption of new requirements in the evolving regulation/standard space

Lead digital communications for Quality

Improves digital acumen across Quality through the development of training and communications

Works with Quality teams to ensure appropriate roles and responsibilities are defined and embedded across the organization

Drive deployment of new or enhanced digital and analytics solutions:

Partner with Business and Technology counterparts to conduct evaluations of new technologies, identify opportunities and develop/implement business case to realize benefits of new technologies across GSK

Deploy core digital Quality capabilities to enable automation and informed decision making

Assure appropriate data management for the Quality Domain

Support multi-cloud data environment ingestion and development and management of Common Quality Data Model (CQDM)

Oversight of Quality data domain to ensure curation and accessibility of data sets per Quality requirements

Work with Global Business Process Owners to ensure appropriate curation of data to support digital and analytics

Ensure connectivity between Master Data Management, SAP/S4HANA, and other key functional or enterprise data-related initiatives

Maintain Digital and Analytics Operations

Create and maintain model for BAU support through lifecycle management of solutions 

Establish and drive a roadmap to deliver standardized reporting capabilities as an enabler of business performance management

Govern, maintain/sustain reporting tools and drive continuous improvement; Manage processes for break/fix and enhancement requests for Tech

Drive organizational change management (standardized usage) and provide support to user community