Clinical Development Director
Contract Type: 18-month Contract
Location: Hybrid or Remote
Rate: £700/day via Umbrella only
Job Purpose
The Clinical Development Director (CDD) is a clinical/scientific expert who provides leadership and support across global clinical development programs and trials. This role ensures the delivery of high-quality clinical strategies, protocols, data reviews, and regulatory documentation under the guidance of the Global Program Clinical Head (GPCH).
Our client our hiring for clinical development directors in 3 different therapy areas – Cardio Renal Metabolic, Immunology and Neuroscience. The ideal candidate will hold a PhD in a relevant subject, and have 7 years of experience in clinical research or drug development.
Key Responsibilities
Clinical Strategy & Delivery
* Lead or support clinical deliverables within assigned program sections.
* Develop clinical sections of protocols aligned with Integrated Development Plans (IDPs).
* Review clinical data and ensure program-specific standards.
Data Analysis & Reporting
* Contribute to final analyses, Clinical Study Reports (CSRs), publications, and presentations.
Regulatory Documentation
* Lead development of clinical sections for regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers).
Clinical Data Oversight
* Conduct ongoing review of trial data with medical monitors and clinical experts.
* Collaborate with data management and statistics teams.
Inspection Readiness
* Prepare for audits and inspections, including risk assessments and mock interviews.
* Review abstracts, presentations, and manuscripts.
Team Leadership
* May manage Clinical Scientific Experts (CSEs) and support career development.
* Provide onboarding, training, and mentoring.
Safety Monitoring
* Support safety data monitoring and reporting (e.g., PSURs, DSURs).
* Participate in Safety Management Team (SMT) activities.
Stakeholder Engagement
* Collaborate with internal and external stakeholders (e.g., regulatory authorities, KOLs, patient advocacy groups).
Translational & Business Development
* Support transition of pre-PoC projects and contribute to BD&L activities.
Training & Initiatives
* Deliver medical/scientific training and lead global initiatives (e.g., SOP development, process improvement).
Clinical Trial Leadership
* May lead clinical trials as Clinical Scientific Lead in collaboration with medical monitors.
Ideal Candidate Profile
Experience & Skills:
* 7+ years in clinical research or drug development (Phases I–IV).
* PhD preferred in relevant areas
* 3+ years in global clinical trial execution and reporting.
* Strong scientific partnerships and stakeholder engagement.
* Thorough understanding of GCP, trial design, statistical methods, and regulatory processes.
* People management experience (matrix/global preferred).
* Excellent communication, interpersonal, and conflict resolution skills.
Team & Financial Scope
May lead a team of ~3 direct/indirect reports.
* Responsible for clinical program budgets exceeding $20 million.