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 is hiring for clinical development directors in three different therapy areas – Cardio Renal Metabolic, Immunology and Neuroscience. The ideal candidate will hold a Ph.D. in a relevant subject, and have 7 years of experience in clinical research or drug development.
Key Responsibilities
* 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.
* Contribute to final analyses, Clinical Study Reports (CSRs), publications, and presentations.
* Lead development of clinical sections for regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers).
* Conduct ongoing review of trial data with medical monitors and clinical experts.
* Collaborate with data management and statistics teams.
* Prepare for audits and inspections, including risk assessments and mock interviews.
* Review abstracts, presentations, and manuscripts.
* May manage Clinical Scientific Experts (CSEs) and support career development.
* Provide onboarding, training, and mentoring.
* Support safety data monitoring and reporting (e.g., PSURs, DSURs).
* Participate in Safety Management Team (SMT) activities.
* Collaborate with internal and external stakeholders (e.g., regulatory authorities, KOLs, patient advocacy groups).
* Support transition of pre-PoC projects and contribute to BD&L activities.
* Deliver medical/scientific training and lead global initiatives (e.g., SOP development, process improvement).
* May lead clinical trials as Clinical Scientific Lead in collaboration with medical monitors.
Ideal Candidate Profile
* 7+ years in clinical research or drug development (Phases I–IV).
* Ph.D. 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.
* Excellent communication, interpersonal, and conflict resolution skills.
* May lead a team of ~3 direct/indirect reports.
* Responsible for clinical program budgets exceeding $20 million.
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