Senior Director, Clinical Lead
3 weeks 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.
We are committed to creating a diverse and inclusive workplace that reflects the communities we serve. We welcome applications from qualified candidates who share our values and are passionate about making a difference in the lives of patients.
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.
We are an equal opportunities employer and welcome applications from all qualified candidates. In the US, we also adhere to Affirmative Action principles, ensuring 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.
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