Medical Director
PROMEGA CORPORATION Medical Director MADISON, Wisconsin
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 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 :
- 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.
- 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).
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.).
- 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).
- 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).
Stakeholder Engagement : 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).
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
APPLICATION INSTRUCTIONS : Apply Online : ipc.us / t / 526CF989AA2B41B5. Qualified females, minorities, special disabled veterans, and other veterans are encouraged to apply.
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