- Devise and implement region-specific clinical development strategies to meet regulatory requirements
- Through understanding of the region and needs of patients, differentiate company's pipeline assets and develop appropriate strategies
- Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions.
- Responsible for development team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
- Recommends scope, complexity and size, and influence the budget of all aspects of a program.
- Provide scientific and medical advice for CNS clinical trial (mainly Phase III)
- Supports Company's visibility and position within the healthcare environment through publications and presentations at national and international meetings
- Provides medical support to regional regulatory affairs activities
- Develops, reviews and revises protocols, case report forms, training materials, project specific tools, analysis plans design, clinical trial reports and new drug applications
- Responsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific, medical and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
- Medical Degree qualified and Board certified neurologist/psychiatrist
- Candidates with strong background in CNS will also be considered.
- Min 4 years experience in drug development process & clinical research within the pharmaceutical industry
Email resume to firstname.lastname@example.org for a confidential discussion