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Reports To:
Chief Medical Officer (CMO)
The Senior Medical Director will play a crucial role in drug development activities, focusing on developing Psilocybin programs. This position involves providing clinical expertise across various stages of the drug development process, including indication selection, clinical development planning, protocol design, regulatory submissions, medical monitoring, and data analysis. The Senior Medical Director will support the Chief Medical Officer and work closely with cross-functional teams to drive the success of psilocybin development programs. The ideal candidate will have a passion for clinical research involving novel therapeutics (e.g., psychedelic drugs) and a proven track record of relevant clinical development within the pharmaceutical industry.
Responsibilities: Provide comprehensive medical oversight for sponsored clinical trials. Ensure the overall safety of clinical trial participants, serve as physician contact for CRO medical monitor(s), support safety reporting and pharmacovigilance activities, and manage medical emergencies if they occur. Collaborate with Clinical Operations and designated CROs to execute the clinical trials (e.g., perform data and coding reviews; draft/present clinical slides for Investigator Meetings; participate in DSMB planning therapeutic/monitor training; develop/review key study plans). Collaborate with the Regulatory Affairs team regarding clinical development strategy and preparation of regulatory submissions (e.g., investigator brochures, annual reports, clinical study reports, meeting briefing documents, etc.). Collaborate in designing and optimizing study protocols to ensure they are scientifically rigorous and ethical, and appropriately address key clinical questions to support future marketing application(s). Oversee the collection, analysis, and interpretation of clinical data. Ensure the accurate and timely reporting of trial results and conclusions (i.e., in clinical study reports, abstracts, and manuscripts). Engage with key stakeholders regarding drug development activities and strategy. Provide clinical support in interactions with internal and external partners (e.g., regulatory authorities, key opinion leaders, data safety monitoring boards, advisory boards, patient advocacy groups, etc.). Provide leadership and mentorship to the clinical trial team(s) and other staff, as appropriate. Contribute to medical/scientific training regarding the therapeutic area and drug(s) under development. Foster a collaborative multidisciplinary team environment by communicating relevant research findings and clinical insights. Support SOP development and process improvement activities. Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
Qualifications: Medical Degree (MD or DO) with board certification in Psychiatry, Neurology, or a related field. Extensive experience designing and conducting clinical trials, particularly late stage (Phase 2/3), with a deep understanding of clinical trial methodology and relevant FDA regulations and guidance. Is proficient with medical coding activities (i.e., MedDRA, WHO Drug). 5 years of relevant experience in the pharmaceutical industry. Clinical expertise in psychiatric disorders of potential clinical development interest (e.g., major depressive disorder, post-traumatic stress disorder, acute stress disorder, prolonged grief disorder, adjustment disorder, etc.). Publication record in relevant therapeutic areas or clinical trial-related topics. Prior experience in managing large, multicenter clinical trials. Deep understanding of psychedelic-assisted therapy and the psychopharmacology of psychedelic drugs. Proven experience contributing to regulatory submissions and interactions with the FDA, including knowledge of relevant regulations and guidance, IND applications, advisory committee-related activities, and Risk Evaluation and Mitigation Strategies (REMS). Demonstrated leadership skills with the ability to manage a multidisciplinary team effectively. Strong verbal communication and technical writing skills.
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Chief Medical Officer (CMO)
The Senior Medical Director will play a crucial role in drug development activities, focusing on developing Psilocybin programs. This position involves providing clinical expertise across various stages of the drug development process, including indication selection, clinical development planning, protocol design, regulatory submissions, medical monitoring, and data analysis. The Senior Medical Director will support the Chief Medical Officer and work closely with cross-functional teams to drive the success of psilocybin development programs. The ideal candidate will have a passion for clinical research involving novel therapeutics (e.g., psychedelic drugs) and a proven track record of relevant clinical development within the pharmaceutical industry.
Responsibilities: Provide comprehensive medical oversight for sponsored clinical trials. Ensure the overall safety of clinical trial participants, serve as physician contact for CRO medical monitor(s), support safety reporting and pharmacovigilance activities, and manage medical emergencies if they occur. Collaborate with Clinical Operations and designated CROs to execute the clinical trials (e.g., perform data and coding reviews; draft/present clinical slides for Investigator Meetings; participate in DSMB planning therapeutic/monitor training; develop/review key study plans). Collaborate with the Regulatory Affairs team regarding clinical development strategy and preparation of regulatory submissions (e.g., investigator brochures, annual reports, clinical study reports, meeting briefing documents, etc.). Collaborate in designing and optimizing study protocols to ensure they are scientifically rigorous and ethical, and appropriately address key clinical questions to support future marketing application(s). Oversee the collection, analysis, and interpretation of clinical data. Ensure the accurate and timely reporting of trial results and conclusions (i.e., in clinical study reports, abstracts, and manuscripts). Engage with key stakeholders regarding drug development activities and strategy. Provide clinical support in interactions with internal and external partners (e.g., regulatory authorities, key opinion leaders, data safety monitoring boards, advisory boards, patient advocacy groups, etc.). Provide leadership and mentorship to the clinical trial team(s) and other staff, as appropriate. Contribute to medical/scientific training regarding the therapeutic area and drug(s) under development. Foster a collaborative multidisciplinary team environment by communicating relevant research findings and clinical insights. Support SOP development and process improvement activities. Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
Qualifications: Medical Degree (MD or DO) with board certification in Psychiatry, Neurology, or a related field. Extensive experience designing and conducting clinical trials, particularly late stage (Phase 2/3), with a deep understanding of clinical trial methodology and relevant FDA regulations and guidance. Is proficient with medical coding activities (i.e., MedDRA, WHO Drug). 5 years of relevant experience in the pharmaceutical industry. Clinical expertise in psychiatric disorders of potential clinical development interest (e.g., major depressive disorder, post-traumatic stress disorder, acute stress disorder, prolonged grief disorder, adjustment disorder, etc.). Publication record in relevant therapeutic areas or clinical trial-related topics. Prior experience in managing large, multicenter clinical trials. Deep understanding of psychedelic-assisted therapy and the psychopharmacology of psychedelic drugs. Proven experience contributing to regulatory submissions and interactions with the FDA, including knowledge of relevant regulations and guidance, IND applications, advisory committee-related activities, and Risk Evaluation and Mitigation Strategies (REMS). Demonstrated leadership skills with the ability to manage a multidisciplinary team effectively. Strong verbal communication and technical writing skills.
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