Job Title: Clinical Development Director (CDD) – Neuroscience
About the Role
We are seeking an accomplished Clinical Development Director (CDD) with deep expertise in clinical research and drug development to join our global development team. Acting as a clinical and scientific expert, you will provide leadership and oversight for clinical deliverables across late-phase clinical programs and global trials. This is a high-impact role, working cross-functionally with global stakeholders to shape strategy, ensure regulatory compliance, and drive successful trial execution within neuroscience and related therapeutic areas.
Key Responsibilities
* Lead and deliver assigned clinical development activities including strategy, protocols, data review, regulatory submissions, and publications.
* Provide clinical input into final analyses, CSRs, abstracts, presentations, and manuscripts.
* Develop and review clinical sections of trial and program-level regulatory documents (e.g., IBs, briefing books, dossiers, responses to authorities).
* Oversee ongoing scientific and clinical review of trial data in close collaboration with medical monitors, data management, and biostatistics teams.
* Support inspection readiness, risk assessments, audit preparation, and QA interactions.
* Contribute to safety monitoring, reporting, and signal detection, working closely with SMT and patient safety colleagues.
* Engage with external stakeholders (regulators, KOLs, advisory boards) and internal partners across R&D, translational medicine, and global functions.
* Mentor, train, and support team members, fostering career development and knowledge transfer.
* Lead or contribute to global initiatives such as process improvements, SOP development, and clinical development line function projects.
Ideal Candidate Profile
* Education: PhD in Neuroscience (or closely related discipline).
* Experience: ≥ 7 years in clinical research or drug development, with ≥ 3 years leading global clinical trials (Phases I–IV) in the pharmaceutical industry.
* Strong late-phase clinical development experience is essential.
* Advanced knowledge of neuroscience, with preference for candidates experienced in Cell & Gene, Neurodegeneration, Rare/Neuromuscular Diseases, Neuroinflammation, and/or conditions such as Multiple Sclerosis, Huntington's Disease, Myasthenia Gravis.
* Solid understanding of GCP, clinical trial design, methodology, and regulatory frameworks.
* Track record of scientific contributions, publications, and stakeholder engagement.
* Strong leadership, communication, and collaboration skills with experience in people management (matrix/global environment desirable).
* Excellent problem-solving, negotiation, and conflict resolution abilities.
Why Join Us?
This is an exciting opportunity to play a pivotal role in advancing groundbreaking therapies in neuroscience. You will join a collaborative, global environment where your expertise and leadership will directly influence clinical strategies and outcomes that improve patients’ lives worldwide.