Job Title: Clinical Development Director
Contract: 18-Month Fixed Term
Location: Hybrid or Remote
About the Role
We are seeking an experienced Clinical Development Director (CDD) to provide clinical leadership and scientific expertise across a global clinical development program. In this pivotal role, you will oversee clinical development strategy, trial design, execution, and data review, while ensuring alignment with regulatory requirements and business objectives. You will act as a subject matter expert, collaborating with cross-functional teams and external stakeholders to deliver high-quality, timely clinical outcomes.
Key Responsibilities
* Lead or support delivery of assigned clinical development activities, including clinical development strategies, trial protocols, data review, and regulatory submissions.
* Develop and review clinical sections of regulatory documents (Investigator’s Brochures, briefing books, safety updates, dossiers).
* Drive ongoing clinical and scientific review of trial data in collaboration with medical monitors, statisticians, and data management teams.
* Provide clinical input into publications, presentations, and clinical study reports.
* Contribute to inspection readiness and quality assurance activities, including audits and risk assessments.
* Represent the program in interactions with regulatory authorities, advisory boards, key opinion leaders, and patient groups.
* Support program safety reporting (PSURs, DSURs) and act as a member of the Safety Management Team where required.
* Mentor and support team members, contributing to performance management, onboarding, and career development.
* Participate in global initiatives to enhance processes, SOPs, and continuous improvement in clinical development.
* Ensure successful go-live readiness and operational support of trials, aligning with the overall Integrated Development Plan.
Key Performance Indicators (KPIs)
* Timely delivery of high-quality protocols, IDPs/CDPs, regulatory documents, and trial outputs.
* Evidence of strong scientific and clinical data review across assigned therapeutic areas.
* Effective stakeholder engagement with regulators, investigators, and internal leadership teams.
* High-performing, engaged clinical teams with clear contributions to program success.
Ideal Candidate Profile
* Experience: Minimum 7+ years in clinical research/drug development (Phases I–IV), with 3+ years in global clinical trial delivery. Late-phase clinical development experience is essential.
* Therapeutic Area Expertise: Advanced knowledge in Neuroscience, Cell & Gene Therapy, Neurodegeneration, Rare or Neuromuscular diseases, or Neuroinflammation. Preferred experience in Multiple Sclerosis, Huntington’s Disease, Myasthenia Gravis, or similar conditions.
* Education: PhD in Neuroscience (or related field) strongly preferred.
* Knowledge: Strong grounding in GCP, trial methodology, statistical approaches, and regulatory processes.
* Leadership: People management experience (direct or matrix) with proven ability to mentor and develop talent.
* Skills: Excellent communication, collaboration, and stakeholder management, with strong negotiation and conflict resolution abilities.
Why Join Us?
This is a rare opportunity to play a critical leadership role in advancing late-phase clinical development programs that can transform patient lives. You will work in a collaborative global environment, influencing strategy, shaping regulatory outcomes, and contributing to therapies in high-impact therapeutic areas.
👉 Apply now to contribute your expertise to a leading program in neuroscience and clinical development.