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Senior Medical Director - Neuroscience and Psychiatry

Hyper Recruitment Solutions
Columbia, SC Full Time
POSTED ON 3/4/2025
AVAILABLE BEFORE 5/25/2025

Senior Medical Director - Neuroscience and Psychiatry We are seeking a highly skilled Senior Medical Director or Medical Director with a specialization in Psychiatry, particularly with expertise and proven track records in managing medical services in areas such as Schizophrenia, Bipolar Disorder, ADHD, and Major Depressive Disorder, to join our team.The ideal candidate will play a critical role in overseeing clinical trials related to psychiatric disorders, ensuring patient safety, compliance with regulatory standards, and the integrity of clinical data. This position requires strong clinical expertise, the ability to review multiple medical datasets, exceptional communication skills, and a commitment to advancing psychiatric research.Key Responsibilities : Ensuring safety and wellbeing of study subjects, prioritizing their rights, ensuring that ethical standards are maintained.Medical Monitoring : Review and assessment of safety as well as efficacy data including adverse events and serious adverse events, clinical listings, eligibility reviews, and providing timely and thorough medical evaluations. Analyzing clinical trial data to identify trends, safety signals, and overall study outcomes; provide recommendations based on findings.Protocol Development : Collaborate with study teams in designing and developing clinical trial protocols, informed consent forms, and case report forms.Regulatory Compliance : Ensure that all clinical activities comply with ICH-GCP, FDA regulations, and other applicable guidelines.Team Collaboration : Work closely with external parties : sponsors, clinical sites, as well as internal teams : clinical project managers, regulatory affairs, biostatisticians, and other stakeholders to facilitate smooth trial operations.Training and Support : Provide guidance and training to study staff on psychiatric assessments, safety and medical monitoring, and adverse event reporting.Qualifications : Medical degree (MD or DO) from accredited medical university or academy with a specialization in Psychiatry.Experience in all phases of a clinical study from start-up, conduct to closure in specific indications : schizophrenia, bipolar disorder, major depressive disorder.Additional experience in Neurology and other Neuroscience indications is beneficial.At least 2 years of experience for Medical Director role in clinical research, particularly in psychiatric studies, and at least 5 years for Senior Medical Director role.Strong understanding of clinical trial design, regulatory requirements, and GCP and other applicable guidelines.Excellent analytical skills and attention to detail.Outstanding communication and interpersonal skills, with the ability to work collaboratively in a team environment.Proficiency in electronic data capture systems and clinical trial management software.Preferred Qualifications : Board certification in Psychiatry.Experience with medical data evaluation and safety reporting in clinical trials.Familiarity with statistical analysis and interpretation of clinical data.What We Offer : Competitive salary and benefits package.Opportunities for professional development and continuing education.A collaborative and innovative work environment.Seniority level : DirectorEmployment type : Full-timeJob function : Science and ResearchIndustries : Pharmaceutical Manufacturing and Biotechnology Research#J-18808-Ljbffr

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