My client a leading pharma are seeking a Clinical Development Director to lead phase 3 studies within their Clinical Sciences group. They require an experienced individual to drive scientific innovation to deliver the next generation of transformational medicine for patients.
- Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development.
- Ensuring alignment with and support to project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP.
- Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
- Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
- Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
- Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.
- Actively managing and contributing to the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area.
- Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development.
- Interfacing and influencing a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) to deliver clinical programs and align to business strategy and address patient needs.
- Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile.
- Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
- Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses.
- Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery.
- Must have an advance degree MD, PhD, PharmD
- Clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
- Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area.
- Demonstrated experience using new learning and digital tools to create innovation in other areas.
- Understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.
- Demonstrated experience integrating genetic data to inform and guide clinical protocols.
- Proven ability to utilize statistics, and visualization techniques to interpret or analyse complex information and make correct inferences and conclusions.