Clinical Development Director

The opportunity

• The Clinical Development Director is responsible for the development, execution and management of clinical programs worldwide across all phases of clinical research.
• The Clinical Development Director will oversee study teams and will be responsible for leading cross-functional teams in a matrix environment.
• The individual is expected to be able to function independently in the daily management of clinical research projects including the preparation/review of related key documents (i.e. protocols, Investigator’s Brochures, clinical study reports, summaries for regulatory submissions).
• The Clinical Development Director is responsible for designing and implementation of the clinical development plan and will provide leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, and pre-clinical development in this regard.
• The Clinical Development Director will be a key contributor to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. The Clinical Development Director will foster relationships with opinion leaders in assigned disease areas.
  
  

• Will be a core member of the Global Program Team
• Will have and maintain the expertise necessary for the clinical development of the product
• Prepares and manages multiple Clinical Development Plans
• Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion
• Makes presentations at the Investigator Meetings and other relevant internal or external Venues
• Responsible for securing the required human resources to implement the Clinical Development Plan
• Provides clinical leadership and expertise in meetings with Health Authorities globally.
• Provides input and direction to Protocols, Clinical Study Reports and other relevant clinical documents
• Able to secure, manage and maintain critical partnerships with key business partners; Ability to interface professionally with a wide spectrum of internal and external academicians, agencies and industry executives in the scientific/medical arena
• Serves as medical monitor providing medical support and guidance in investigator selection, study design, data collection and study conduct, patient/subject safety and oversees CRO medical monitor.
• Foster relationships with opinion leaders in assigned disease areas.
  
  

• MD
• Board certification in psychiatry and/or strong experience in clinical development in psychiatry
• Pharmaceutical industry experience with 3+ years of experience developing and directing clinical trials.
• Proven track record of leading studies from early stage through to regulatory submissions.
• Must have the ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena
• Must be able to work on multiple projects with aggressive timelines
• Must be able to work independently, without daily direction
• Strong interpersonal and leadership skills
• Excellent oral and written presentation capabilities
• Fluent English