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Director of Immunology Research and Development
2 months ago
Job Title: Director, Clinical Research and Early Programs Immunology
Location: UK - Hertfordshire - Stevenage, UK – London – New Oxford Street
Job Type: Full-time
About the Role:
We are seeking an experienced Director, Clinical Research and Early Programs Immunology to join our team. As a key member of our clinical research and development team, you will be responsible for providing clinical and scientific insights to the immunology franchise, including emerging indications and adjacencies.
Key Responsibilities:
- Design and lead clinical development protocols/studies/programs in Immunology across all phases of development.
- Accountability for clinical development strategy, including study Ph1-2/3 design.
- Provide clinical expert input into regulatory documentation and lead regulatory interactions from a clinical perspective.
- Work closely with research unit members to define prioritized clinical indications for early targets and integrate inputs from across disciplines.
- Accountability for design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile.
- Accountability for leading the integrated evidence planning to address the needs of regulators, payors, and patients.
- Participate/lead the clinical team and integrated evidence team.
- Engage external academic and clinical experts to enhance quality and delivery of clinical programs/studies.
- Provide clinical input into presentations, supporting documentation, and participation in governance bodies.
- Escalate clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance.
- Provide clinical input to regulatory documentation to support the desired indication.
- Address 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.
- Accountability for medical governance across the project to ensure scientific integrity and overall safety of study subjects.
Requirements:
- Primary medical qualification (i.e. medical degree) and a clinical medical specialty qualification.
- Significant proven clinical or scientific expertise in rheumatology/dermatology/immunology.
- Industry or academic experience in translational medicine and early/late phase drug development.
- Understanding and knowledge of early/late drug development and translational sciences.
Preferred Qualifications:
- Primary medical qualification (i.e. medical degree) and PhD with a clinical medical specialty qualification in rheumatology/dermatology/immunology.
- Experience in working with relevant regulatory bodies and professionals in early/late-stage discovery and development.
- Project Management.
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. 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).
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.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, color, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
