Director, Clinical Research and Early Programmes Immunology

Site Name: UK - Hertfordshire - Stevenage, Belgium-Wavre, UK - London - Brentford, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence

Posted Date: May 3 2024

A Director, Clinical Research and Early Programmes Immunology is sought to provide clinical and scientific insights to the immunology 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 with early and late development teams to plan clinical development programs and facilitate close collaboration between different groups within the Respiratory & Inflammation Research Unit.

The responsibilities of the Director Clinical Research and Early Programmes Immunology include (but are not limited to) several key areas:

• designing and leading, as appropriate, clinical development protocols/studies/programs in Immunology across all phases of development, as required by business imperatives as part of clinical and medicine development matrix teams.
• accountability for 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 prioritised 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
• accountability for 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
• accountability for 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)
• accountability for engaging external academic and clinical experts to enhance quality and delivery of clinical programmes/ studies
• accountability, if medically qualified, for 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.)
• accountability, if medically qualified, for 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
• accountability for 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
• accountability for 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
• accountability for incorporating patient perspective in the design and conduct of clinical studies

Leadership

• You will be experienced 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
• You will be expected to input into disease area strategy and be capable of executing this strategy based on your own expertise and that gained from your network
• You will 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
• You will be able to be mentoring and coaching other members of Clinical Research and Early Programmes Immunology – applying extensive knowledge of clinical development to more than one research unit/disease area
• You will be able to build an external network 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

Candidate Profile

Basic Qualifications:

• Doctor of Medicine OR ‘MD, PhD' OR PhD with industry experience
• Significant proven clinical or scientific expertise in rheumatology/dermatology/immunology
• Industry experience in translational medicine and early/late phase drug development; experience of setting and executing scientific strategy, whilst being mindful of overall company goals
• Understanding and knowledge of early/late drug development and translational sciences

Qualifications & Preferable Expertise

In addition to the above, the following will be highly desirable:

• Specialty training in rheumatology/dermatology/ immunology area, in particular lupus and adjacencies, would be advantageous
• Experience in working with relevant regulatory bodies and professionals in early/late stage discovery and development
• Project Management
• Demonstrates the discipline of risk-based planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.

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Uniting science, technology and talent to get ahead of disease together.

GSK is 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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