Senior Director, Clinical Lead
4 weeks ago
We are seeking a highly experienced and skilled Senior Director, Clinical Lead to join our team at GlaxoSmithKline Services Unlimited. 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 Clinical Development Strategy: Develop and execute the clinical development strategy for a drug or program, ensuring alignment with business objectives and regulatory requirements.
- Manage Clinical Development Plans: Oversee the development and implementation of clinical development plans for products and/or indications in specific therapy/disease areas.
- Provide Strategic Leadership: Contribute to the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials.
- Establish Timelines and Deliverables: Establish and deliver to clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
- Develop and Maintain Relationships: Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations, and Statistics.
- Serve as Clinical Point of Contact: Serve as a clinical point of contact for senior management and senior-level matrix teams.
- Contribute to Business Development: Contribute to Business Development activities, including due diligence projects.
- Support Technical and Leadership Development: Support the technical and leadership development of Clinical Sciences staff via direct line management, mentoring, and coaching.
- Interface with External Experts: 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 Evaluation of Probability of Technical Success: Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs.
- Identify Transformational Opportunities: Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
- Assess Risk/Benefit: Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate.
- Make Substantial Contributions to Global Regulatory Interactions: Make substantial contributions to global regulatory interactions and files, including briefing documents, presentations, submission documents, and responses to questions.
- Champion Implementation of Innovative Methods: Champion the implementation of innovative methods and processes within clinical development and gain stakeholder support.
- Bachelor of Science: Bachelor of Science degree in a relevant field.
- Experience in Clinical Drug Development: Experience in the (bio-)pharmaceutical industry in clinical drug development.
- Experience with Planning Clinical Development: Experience with planning clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects.
- Experience with Clinical Research Methodology: 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 with Global Regulatory Filings: Experience of global regulatory filings/submission.
- Line/Matrix Management Experience: 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: MSc, PhD, PharmD, or Medical Degree preferred.
- Specialist Training or Board Qualification: 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: Thorough understanding of respiratory diseases, underlying biology, and potential therapeutic targets.
- Robust Knowledge of ICH and GCP Guidelines: Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements.
- Solid Understanding of Needs and Priorities of Regulators: Solid understanding of needs and priorities of regulators, payors, and prescribers in relevant global market(s).
- Experience Collaborating with Multiple Stakeholders: Experience collaborating with multiple stakeholders on complex projects.
- Record of Building and Maintaining Relationships: Record of building and maintaining strong relationships with internal and external stakeholders.
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