Clinical Development Director
Contract: 18 Months
Therapeutic Areas: Neuroscience (3 roles) & Immunology (2 roles)
About the Role
We are seeking highly skilled Clinical Development Directors (CDD) to join global programs in Neuroscience and Immunology. This is a senior scientific leadership role, responsible for driving clinical development strategy and execution across late-phase trials (Phase 2 & 3).
Important:
* This is not a Project Management role.
* MDs are excluded; candidates must hold a PhD or PharmD (Master’s considered, PhD strongly preferred).
* No training provided – prior clinical development experience is essential.
Key Responsibilities
* Lead and deliver clinical development activities for assigned program sections, including:
* Clinical Development Plans (CDP), trial protocols, regulatory documents, and publications.
* Provide scientific and clinical input into analyses, interpretation, and Clinical Study Reports (CSR).
* Oversee clinical data review and ensure quality in collaboration with data management and biostatistics.
* Contribute to regulatory submissions and responses to health authorities.
* Support safety monitoring and reporting (PSURs, DSURs).
* Represent clinical development in internal and external stakeholder interactions (KOLs, advisory boards, regulatory bodies).
* Mentor and develop clinical team members; may lead a small team (approx. 3 reports).
* Drive inspection readiness and quality standards across programs.
Ideal Background
* Education: PhD or PharmD in relevant field (Neuroscience preferred for Neuro roles).
* Experience:
* ≥7 years in clinical research/drug development (Phases I–IV), with ≥3 years in global clinical trial execution.
* Strong late-phase experience (Phase 2 & 3).
* Therapeutic expertise in Neuroscience (Neurodegeneration, Neuroinflammation, Rare Diseases) or Immunology (Rheumatology, Dermatology acceptable).
* Familiarity with Multiple Sclerosis, Huntington’s Disease, Myasthenia Gravis, or similar conditions is a plus.
* Advanced knowledge of GCP, trial design, regulatory processes, and statistical principles.
* Excellent communication, leadership, and stakeholder management skills.