Director, Clinical Research and Early Programs Immunology

4 weeks ago

Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time
Job Title: Director, Clinical Research and Early Programs Immunology

We are seeking a highly skilled and experienced Director, Clinical Research and Early Programs Immunology to join our team at GlaxoSmithKline. As a key member of our Immunology Research Unit, 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 (CT) and Integrated Evidence Team (IET).
  • Engage external academic and clinical experts to enhance quality and delivery of clinical programs/studies.
  • Provide clinical input into presentations, supporting documentation for, and participation in governance bodies presentations.
  • Escalate clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate.
  • Provide clinical input to regulatory documentation to support the desired indication.
  • Address clinical questions at meetings with regulatory authorities/ethics committees.
  • Regulatory reporting requirements, including Development Safety Update Reports (DSUR's) and IB updates.
  • Incorporate 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.
  • Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor.
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.
Why GSK?

At GlaxoSmithKline, we unite science, technology, and talent to get ahead of disease together. We are a global biopharma company with a special purpose - to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. 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 are an Equal Opportunity Employer and adhere to Affirmative Action principles. We believe in an agile working culture for all our roles and offer a range of benefits and opportunities for growth and development.

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