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We are seeking a highly experienced Senior / Medical Director, Neuroscience with a focus on Psychiatry to join a prestigious CRO. This role is central to ensuring the success and compliance of clinical trials, advancing research in psychiatric disorders, and upholding the highest standards of patient safety and data integrity.
Key Responsibilities
Patient Safety and Ethics : Ensure the safety, rights, and well-being of study participants, upholding ethical and regulatory standards.
Medical Monitoring : Oversee safety and efficacy data reviews, assess adverse events and serious adverse events, and analyze clinical data to identify trends, safety signals, and study outcomes.
Protocol Development : Collaborate with cross-functional teams to design clinical trial protocols, informed consent forms, and case report forms.
Regulatory Compliance : Ensure clinical activities adhere to ICH-GCP, FDA regulations, and other applicable standards.
Team Collaboration : Partner with sponsors, clinical sites, project managers, regulatory teams, and statisticians to ensure smooth trial operations.
Training and Support : Provide training to study staff on psychiatric assessments, safety monitoring, and adverse event reporting.
Qualifications
Medical degree (MD or DO) with a specialization in Psychiatry.
Proven experience in clinical research, particularly in schizophrenia, bipolar disorder, and major depressive disorder.
Experience in Neurology or other Neuroscience indications is a plus.
At least 2 years of experience as a Medical Director or 5+ years for a Senior Medical Director role.
Strong knowledge of clinical trial design, GCP, and regulatory requirements.
Exceptional analytical skills, attention to detail, and proficiency with clinical trial management tools.
Excellent communication and interpersonal skills to foster collaboration in a team environment.
Preferred Qualifications
Board certification in Psychiatry.
Experience with medical data evaluation and safety reporting.
Familiarity with statistical analysis and data interpretation.
Seniority level
Director
Employment type
Full-time
Job function
Research
Industries
Pharmaceutical Manufacturing and Research Services