Medical Director

1 week ago


Toronto, Ontario, Canada PROMEGA CORPORATION Full time
PROMEGA CORPORATION Medical Director MADISON , Wisconsin Apply Now

JOB REQUIREMENTS:
Job Description

JOB OBJECTIVE:

Reporting to the ChiefMedical Officer, the Medical Director will play an important role indrug development activities at Usona Institute.

The Medical Directorwill lead the clinical development of 5-MeO-DMT, a psychedelic drugbeing developed as a novel treatment for a psychiatric indication.

Activities associated with this role will include providing clinicalinput regarding indication selection, preparation of a clinicaldevelopment plan and/or target product profile, protocol design,contribution to regulatory submissions, medical monitoring, and dataanalysis and interpretation.

In addition to leading the clinicaldevelopment of 5-MeO-DMT, the Medical Director will provide support theChief Medical Officer in activities associated with Usona\'s psilocybindevelopment program.

The ideal candidate will have a passion forclinical research involving novel therapeutics (e.g., psychedelic drugs)and a proven track record of relevant clinical development within thepharmaceutical industry.


CORE DUTIES:
1.

Clinical Oversight:
Providecomprehensive medical oversight for Usona-sponsored clinical trials.

Ensure overall safety to clinical trial participants, serve as physiciancontact for CRO medical monitor(s), support safety reporting andpharmacovigilance activities, and manage medical emergencies if theypresent.

2.

Clinical Trial Execution:

Work cooperatively with ClinicalOperations and designated CROs to execute the clinical trials (e.g.,perform data and coding reviews; draft/present clinical slides forInvestigator Meeting; participate in DSMB planning, therapeutic/monitortraining, develop/review key study plans).

3.

Regulatory Collaboration:


Collaborate with the Regulatory Affairs team regarding clinicaldevelopment strategy and preparation of regulatory submissions (e.g.,investigator brochures, annual reports, clinical study reports, meetingbriefing documents, etc.).

4.

Protocol Development:
Collaborate in thedesign and optimization of study protocols to ensure they arescientifically rigorous, ethical, and appropriately address key clinicalquestions to support future marketing application(s)

5 DataInterpretation & Reporting:
Oversee the collection, analysis, andinterpretation of clinical data. Ensure the accurate and timelyreporting of trial results and conclusions (i.e., in clinical studyreports, abstracts, and manuscripts). 6.

Stakeholder Engagement:
Engagewith key stakeholders regarding drug development activities andstrategy. Provide clinical support in interactions with internalexternal partners (e.g., regulatory authorities, key opinion leaders,data... For full info follow application link. Diversity is importantat Promega.

We are proud to be an Equal Opportunity Employer, and makeemployment decisions without regard to race, color, religion, sex,sexual orientation, gender identity, national origin, veteran status,disability, or any other protected class.


APPLICATIONINSTRUCTIONS:

Apply Online:
Qualified females,minorities, and special disabled veterans and other veterans areencouraged to apply.
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