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Senior Director, Clinical Lead
2 months ago
We are seeking a highly experienced Senior Director, Clinical Lead to join our team at GSK. As a key member of our clinical development team, you will be responsible for providing clinical and scientific support for potential new, established, and emerging indications for a late-stage asset in the respiratory portfolio.
Key Responsibilities:- Lead the end-to-end clinical development strategy for a drug or program, managing specific clinical development plans for products and/or indications in specific therapy/disease areas.
- 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.
- Provide strategic leadership, ensuring that clinical study designs are aligned with the IEP and CDP, and consider the scientific rationale, regulatory requirements, product development plan, and commercial goals.
- Establish and deliver to clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
- Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations, and Statistics.
- Serve as a clinical point of contact for senior management and senior-level matrix teams.
- Contribute to strategic and organizational initiatives in Clinical Development.
- Contribute to Business Development activities, including due diligence projects.
- Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring, and coaching.
- Interface with and influence a range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) to deliver clinical programs that align to business strategy and address patient needs.
- Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs.
- Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
- Assess risk/benefit at the study and/or project level, taking action to mitigate risk where appropriate.
- Make substantial contributions to global regulatory interactions and files, including briefing documents, presentations, submission documents, and responses to questions.
- Champion implementation of innovative methods and processes within clinical development and gain stakeholder support, encouraging others to think differently and produce business solutions.
- Bachelor of Science
- Experience in (bio-)pharmaceutical industry experience in clinical drug development.
- Experience with planning clinical development for an asset and/or indication, with a proven record of delivery of clinical trials and projects.
- Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules.
- Experience of global regulatory filings/submission.
- Line/matrix management experience, including coaching, mentoring, and development, with a record of inspiring and motivating high-performance teams.
- MSc, PhD, PharmD, or Medical Degree preferred.
- If Physician, specialist training or board qualification/eligibility (or having completed the comparable level of post-medical school clinical training).
- Thorough understanding of respiratory diseases, underlying biology, and potential therapeutic targets.
- Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements.
- Solid understanding of needs and priorities of regulators, payors, and prescribers in relevant global market(s).
- Experience collaborating with multiple stakeholders on complex projects.
- Record of building and maintaining strong relationships with internal and external stakeholders.
