DiaMedica Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments where there is a significant unmet clinical need or where no current therapies are available.
Join DiaMedica at a pivotal moment — our lead candidate addresses life-threatening conditions where timely, sound medical decisions can change outcomes for people suffering from acute ischemic stroke and preeclampsia. As Medical Monitor, you will be the clinical steward for our trials: protecting participant safety, safeguarding data integrity, and translating clinical insight into development strategy.
Key responsibilities (day-to-day + strategic)
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Serve as the primary medical contact for assigned trials: review eligibility questions, adjudicate complex cases, and provide timely decisions on AEs/SAEs and protocol deviations.
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Conduct ongoing medical review of safety data (AEs/SAEs, labs, vital signs) and trend analyses; propose safety actions (protocol amendments, hold recommendations) when clinically indicated.
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Develop and maintain clinical documents: Medical Monitoring Plan, safety management plan, adjudication charters, and clinical sections of protocols and ICFs.
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Represent DiaMedica in safety-focused meetings (DSMB/IDMC, Safety Management Team, investigator calls) and prepare medical input for regulatory interactions and briefing materials.
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Collaborate day-to-day with Clinical Operations, Data Management, Pharmacovigilance, Biostatistics and Regulatory to ensure aligned, rapid decisions and clean, analyzable data.
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Provide clinical input to endpoint definitions, adjudication processes, and clinical strategy (TPP, risk/benefit assessments, publication plans).
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Mentor/sub-investigator support: conduct investigator training on protocol safety/treatment algorithms and be available as an escalation point for site medical questions.
Required Qualifications:
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Medical degree (MD/DO or equivalent) with active license; board certification in neurology, internal medicine, maternal-fetal medicine, critical care, or related specialty is strongly preferred.
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Demonstrated clinical trial experience: minimum 2–4 years of direct involvement in clinical trials (as investigator, sub-investigator, or medical monitor); experience assessing eligibility and making SAE causality/relatedness determinations.
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Safety oversight track record: has led SAE/AEs case reviews, participated in DSMB/IDMC activities, or authored a medical monitoring plan used in an interventional study.
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Therapeutic relevance: prior exposure to stroke, neurology, maternal-fetal medicine, or critical care settings (clinical practice or research) — even a single prior trial in these areas is strongly preferred.
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Behavioral indicators of success: quick, evidence-based decision-making under uncertainty; documented examples of balancing patient safety with trial continuity; clear history of cross-functional collaboration (e.g., co-authored protocol amendments, authored safety memos, taught investigator training sessions).
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Communication & documentation: ability to produce clear medical narratives and regulatory-quality sections for submissions; experience participating in regulatory interactions is a plus.
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Practical skills: comfortable with EDC systems and reviewing blinded/unblinded datasets with biostatistics; familiarity with ICH-GCP and FDA/EMA SAE reporting expectations.
Preferred Qualifications
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Experience in small biotech environment (rapid changes, broad scope).
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Prior safety/Pharmacovigilance collaboration experience or medical affairs exposure.
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Publications, abstracts, or manuscript authorship related to clinical trials.
What we offer
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High-impact work where your decisions directly shape patient safety and program advancement.
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Small, cross-functional team with visibility to leadership and opportunity to influence how our candidate moves through development.
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Competitive compensation and equity; flexible working model.
DiaMedica offers a variety of benefits to eligible employees, including health insurance coverage, wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and vacation time, and many others. Many of these benefits are subsidized or fully paid for by the company.
DiaMedica Therapeutics Inc. believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.