EPM Scientific are on the lookout for a top tier candidate to fill a vacancy with a client of ours on a 2 year contract as a Medical Director, Duties and responsibilities will be listed below.
We are seeking a highly experienced Senior / Medical Director, Neuroscience with a focus on Psychiatry. 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.
If interested, please respond with an up to date resume and expect to hear back soon!
