Medical Director
Company: Promega Corporation
Location: Madison
Posted on: May 9, 2024
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Job Description:
Job Description 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.
Keywords: Promega Corporation, Madison , Medical Director, Healthcare , Madison, Wisconsin
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