Senior Director, Clinical Lead - Respiratory, Brentford
Client: 1054 GlaxoSmithKline Services Unlimited
Location: Brentford, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: f62d377b37a2
Job Views: 4
Posted: 11.03.2025
Expiry Date: 25.04.2025
Job Description:
We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together.
A Senior Director, Clinical Lead is sought to provide clinical and scientific support for potential new, established, and emerging indications for a late stage, asset in the respiratory portfolio. As Senior Director of Clinical Development, you will work with project teams to plan and assure delivery of clinical research and development activities.
Key responsibilities:
1. 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.
2. 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.
3. Provide strategic leadership, ensuring that the clinical study designs are aligned with the IEP and CDP.
4. Establish and deliver to clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
5. Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
6. Serve as a clinical point of contact for senior management and senior level matrix teams.
7. Contribute to the strategic and organizational initiatives in Clinical Development.
8. Contribute to Business Development activities, including due diligence projects.
9. Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching.
10. Interface with and influence a range of scientific external experts to deliver clinical programs that align to business strategy.
11. Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs.
12. Identify and highlight transformational opportunities where projects can offer significant benefit to patients.
13. Assess risk/benefit at the study and/or project level and take action to mitigate risk where appropriate.
14. Make substantial contributions to global regulatory interactions and files.
15. Champion implementation of innovative methods and processes within clinical development.
Basic Qualifications:
1. Bachelor of Science
2. Experience in (bio-)pharmaceutical industry in clinical drug development.
3. Experience with planning clinical development for an asset and/or indication.
4. Experience of clinical research methodology and principles of biostatistics.
5. Experience of global regulatory filings/submission.
6. Line/matrix management experience including coaching, mentoring and development.
Preferred Qualifications:
1. MSc, PhD, PharmD or Medical Degree preferred
2. If Physician, specialist training or board qualification/eligibility.
3. Thorough understanding of respiratory diseases and potential therapeutic targets.
4. Robust knowledge of ICH and GCP guidelines.
5. Solid understanding of needs and priorities of regulators, payers, and prescribers.
6. Experience collaborating with multiple stakeholders on complex projects.
7. Record of building and maintaining strong relationships with internal and external stakeholders.
As an Equal Opportunity Employer, we are open to all talent. We believe in an agile working culture for all our roles.
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