JOB OBJECTIVE: Reporting to the Chief Medical Officer, the Medical Director will play an important role in drug development activities at Usona Institute. The Medical Director will lead the clinical development of 5-MeO-DMT, a psychedelic drug being developed as a novel treatment for a psychiatric indication. Activities associated with this role will include providing clinical input regarding indication selection, preparation of a clinical development plan and/or target product profile, protocol design, contribution to regulatory submissions, medical monitoring, and data analysis and interpretation. In addition to leading the clinical development of 5-MeO-DMT, the Medical Director will provide support the Chief Medical Officer in activities associated with Usona's psilocybin development program. 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.
CORE DUTIES:
1. Clinical Oversight: Provide comprehensive medical oversight for Usona-sponsored clinical trials. Ensure overall safety to clinical trial participants, serve as physician contact for CRO medical monitor(s), support safety reporting and pharmacovigilance activities, and manage medical emergencies if they present.
2. Clinical Trial Execution: Work cooperatively with Clinical Operations and designated CROs to execute the clinical trials (e.g., perform data and coding reviews; draft/present clinical slides for Investigator Meeting; participate in DSMB planning, therapeutic/monitor training, develop/review key study plans).
3. Regulatory Collaboration: 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.).
4. Protocol Development: Collaborate in the design and optimization of study protocols to ensure they are scientifically rigorous, ethical, and appropriately address key clinical questions to support future marketing application(s).
5. Data Interpretation & Reporting: 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).
6. Stakeholder Engagement: Engage with key stakeholders regarding drug development activities and strategy. Provide clinical support in interactions with internal external partners (e.g., regulatory authorities, key opinion leaders, data safety monitoring boards, advisory boards, patient advocacy groups, etc.).
7. Team Leadership & Development: Provide leadership and mentorship to clinical trial team(s) and other Usona 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.
8. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
9. Embraces Promega's 6 Emotional & Social Intelligence (ESI) core principles and implements them in daily work.
10. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
KEY QUALIFICATIONS:
1. Medical Degree (MD or DO) with board certification in Psychiatry, Neurology, or a related field.
2. Extensive experience in the design and conduct of 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).
3. 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.).
4. Deep understanding of psychedelic-assisted therapy and the psychopharmacology of psychedelic drugs.
5. Proven experience in contributing to regulatory submissions and interactions with the FDA, including knowledge of relevant regulations and guidance, IND applications, advisory committee-related activities, Risk Evaluation and Mitigation Strategies (REMS).
6. Demonstrated leadership skills with the ability to effectively manage a multidisciplinary team.
7. Strong verbal communication and technical writing skills.
PREFERRED QUALIFICATIONS:
1. Publication record in relevant therapeutic areas or clinical trial-related topics.
2. Prior experience in managing large, multicenter clinical trials.
3. At least 5 years of relevant experience in the pharmaceutical industry.
PHYSICAL DEMANDS:
1. Ability to remain stationary for extended periods.
2. Ability to travel to multiple sites and manage a flexible schedule, including occasional weekends and evenings, as required by trial needs.
At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.