Director, Clinical Research and Early Programmes Immunology
il y a 1 semaine
Director, Clinical Research and Early Programmes Immunology is wanted to provide clinical and scientific insights to the immunology franchise including emerging indications and adjacencies. The role involves working in project teams to plan and ensure delivery of clinical research and development activities, as well as collaborating closely with 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 clinical development protocols/studies/programs in Immunology across all phases of development.
- Accountability for study Ph1-2/3 design.
- Providing clinical expert input into regulatory documentation and leading regulatory interactions from a clinical perspective.
- Collaborating with Research Unit members to prioritize clinical indications and integrate inputs across disciplines to contribute to various plans and profiles.
- Designing and delivering effective early and full development plans demonstrating proof of concept and benefit-risk.
- Leading integrated evidence planning to address regulatory needs.
- Engaging external experts to enhance the quality of clinical programs.
- Providing medical governance across projects to ensure scientific integrity and participant safety.
- Contributing clinical input to various presentations and regulatory documentation.
- Addressing clinical questions at meetings with regulatory authorities and ethics committees.
- Incorporating patient perspectives in the design and conduct of clinical studies.
Leadership
- Experienced in drug development and/or translational medicine, preferably with industry experience.
- Expected to work across multiple projects and be independently accountable.
- Capable of inputting into disease area strategy and executing it based on expertise and network knowledge.
- Playing a leadership role in various medical governance initiatives, discovery/development policies, processes/guidelines, and professional networks.
- Contributing to relevant business development activities and mentoring/coaching team members.
- Building an external network and utilizing knowledge to influence a culture of improvement in drug development.
Candidate Profile
Basic Qualifications:
- Doctor of Medicine, MD, PhD, or PhD with industry experience.
- Significant expertise in areas like rheumatology, dermatology, and immunology.
- Industry experience in translational medicine and early/late-phase drug development.
- Understanding of early/late drug development and translational sciences.
Qualifications & Preferable Expertise
- Specialty training in rheumatology/dermatology/immunology, particularly in specific areas, is advantageous.
- Experience in working with regulatory bodies and professionals in early/late-stage discovery and development.
- Project Management skills and the ability to execute scientific strategies effectively.
- Discipline in risk-based planning, organizing, and managing resources to meet project goals and quality metrics.
We're thrilled to be moving to a vibrant new home on New Oxford Street in central London from June 2024. At GSK HQ, we're creating an energizing space for connection, collaboration, and disease advancement. The new workspace will promote wellbeing, innovation, and collaboration.
Why GSK?
Uniting science, technology, and talent to advance disease treatment together. GSK focuses on the immune system science and invests in key therapeutic areas to prevent and treat diseases. Join us in our mission to positively impact global health and deliver sustainable returns, fostering a workplace where all can thrive.
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