We're currently seeking a Clinical Development Director, Emerging Therapy Areas. This exciting role will give you the opportunity to collaborate with Discovery Medicine Leads to design clinical strategies for programs in the early development portfolio, as well as work alongside the Disease Area Lead for Cardiovascular, Neuroscience and Emerging Therapy Areas to identify and evaluate promising external substrate that are anchored in human genetics and the science of the immune system, which could supplement and enhance the organic pipeline.
If you're looking to collaborate with world-class physicians and scientists and work in a culture that incentivises courageous and smart risk-taking to help deliver the next generation of transformational medicines, this is the role for you!
Job purpose and key responsibilities :
Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
Working with colleagues in Business Development to identifying and evaluate transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
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
Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members
Actively contributing or leading 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) in order 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.
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
Basic Qualifications :
Clinical drug development industry experience, ideally in Neuroscience
Significant 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
Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s)
Demonstrated experience using new learning and digital tools to create innovation in other areas
Thorough 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 visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions
Preferred Qualifications :
Additional higher research degree (PhD)
An understanding of Neuroscience, the underlying biology and potential therapeutic targets as well as current and future potential treatment
Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance