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Job Purpose
As Medical Director, you will be responsible for providing medical and scientific leadership for the successful execution and reporting of the medical aspects of Phase 2 and 3 clinical trials. Additionally, this role acts as the internal medical expert and will serve as a medical resource for the team, contributing to the growth and development of MoonLake organization. This is a hands-on role working with experienced colleagues as part of a cross-functional team.
Major Accountabilities
1. Provide medical oversight of outsourced study conduct, including interactions with CRO medical and drug safety teams.
2. Contribute medical input to operational documents and plans, such as CRFs, medical monitoring plans, laboratory manuals, deviation management plans, etc.
3. Perform medical data reviews to maintain oversight of efficacy, safety profiles, and quality issues for trials.
4. Work with Drug Safety to evaluate Serious Adverse Events and develop Safety Management, Pharmacovigilance, and Risk Management Plans.
5. Ensure safety overview and medical monitoring of trials.
6. Organize and support DMCs, ensuring compliance with ICH-GCP and regulatory standards.
7. Develop clinical sections of regulatory documents, including protocols, Investigator’s Brochure updates, safety updates, and Clinical Study Reports.
8. Collaborate with Clinical Operations and CROs to execute programs, including study start-up, team meetings, data reviews, and training materials.
Your Profile
Education: Medical Degree and/or Degree in Sciences.
Experience:
* At least 5 years of clinical research experience in biotech or pharma, ideally in Dermatology, Rheumatology, or Inflammatory diseases.
* Knowledge of regulatory drug development in US and EU markets.
* Experience interacting with authorities like EMA and FDA is a plus.
Skills and Competencies
* Board certification in Dermatology and/or Rheumatology is advantageous.
* Strong understanding of clinical drug development and GCP.
* Ability to evaluate and interpret complex scientific data independently.
* Experience working within multidisciplinary teams.
* Excellent organizational, planning, and communication skills.
Work Location
* 2 days per week in Cambridge or Porto offices.
Why Join Us?
MoonLake offers an exciting opportunity to work in a dynamic, innovative environment dedicated to transforming healthcare. We provide learning opportunities, impactful projects, flexible work arrangements, and clear career progression paths.
Our Core Values
* We do Stellar Science: Creating high-quality, innovative therapies.
* We go beyond: Challenging norms boldly and positively disrupting the field.
* We unlock value: Building long-term value for investors and communities.
About Us
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on inflammatory diseases, with progress in global clinical programs. Founded in 2021, headquartered in Zug, with hubs in Cambridge & Porto. More info at www.moonlaketx.com
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