Director Clinical Development
1 week ago
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.
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