Sr Medical Director, Neuroscience and Psychiatry
Medical Director, Psychiatry (Schizophrenia) - LATAM (2-Year Contract)
Location: Latin America (Remote/Hybrid options available)
A leading global Contract Research Organization (CRO) is seeking a highly experienced Medical Director or Senior Medical Director specializing in Neuroscience with a focus on Psychiatry (Schizophrenia studies). This role plays a pivotal part in ensuring the success, safety, and compliance of clinical trials across the LATAM region, particularly in psychiatric research.
About the Organization
With a strong presence across North America, Europe, Asia-Pacific, and Latin America, our organization partners with emerging biotech and pharmaceutical companies to deliver tailored clinical development and resourcing solutions. Backed by a diversified multinational conglomerate with over a century of legacy and multi-billion-dollar annual revenue, we combine global expertise with local insight to advance clinical research worldwide.
Key Responsibilities
- Patient Safety & Ethics: Safeguard the rights and well-being of study participants while ensuring adherence to ethical and regulatory standards.
- Medical Monitoring: Conduct ongoing safety and efficacy reviews, evaluate adverse events (AEs/SAEs), and analyze clinical data for trends and safety signals.
- Protocol Development: Collaborate with cross-functional teams to design protocols, informed consent forms, and case report forms.
- Regulatory Compliance: Ensure all clinical activities comply with ICH-GCP, FDA, and local LATAM regulatory requirements.
- Team Collaboration: Work closely with sponsors, clinical sites, project managers, regulatory teams, and statisticians to ensure seamless trial execution.
- Training & Support: Provide training on psychiatric assessments, safety monitoring, and adverse event reporting to study staff.
Qualifications
- Medical degree (MD or DO) with specialization in Psychiatry.
- Demonstrated experience in clinical research, particularly in schizophrenia, bipolar disorder, and major depressive disorder.
- Experience in Neurology or broader Neuroscience indications is advantageous.
- Minimum of 2 years as a Medical Director.
- In-depth knowledge of clinical trial design, GCP, and regulatory frameworks.
- Strong analytical skills and proficiency with clinical trial management systems.
- Excellent communication and interpersonal skills for effective cross-functional collaboration.
Preferred Qualifications
- Board certification in Psychiatry.
- Experience in medical data evaluation and safety reporting.
- Familiarity with statistical analysis and clinical data interpretation.
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