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. This role acts as the internal medical expert, serving as a medical resource for the team and contributing to the growth and development of MoonLake. It is a hands-on role working with experienced colleagues within a cross-functional team.
Major Accountabilities
* Provide medical strategic input to the assigned project or section of a clinical program.
* Oversee outsourced study conduct, including interactions with CRO medical and drug safety teams.
* Review documents and plans such as CRFs, medical monitoring plans, laboratory manuals, and deviation management plans.
* Perform medical data reviews to monitor efficacy, safety profiles, and quality issues.
* Collaborate with Drug Safety to evaluate Serious Adverse Events and develop Safety Management, Pharmacovigilance, and Risk Management Plans.
* Ensure safety oversight and medical monitoring of trials.
* Organize and support DMCs, ensuring compliance with ICH-GCP and regulatory requirements.
* Develop clinical sections of regulatory documents, including protocols, Investigator’s Brochure updates, safety updates, and Clinical Study Reports.
* Work with Clinical Operations and CROs to execute programs, including study startup, team meetings, data reviews, and training materials.
* Create and approve internal and external training materials and processes.
Your Profile
* Education: Medical Degree and/or Degree in Sciences.
* Experience: Minimum of 5 years in clinical research within biotech or pharma, preferably in Dermatology, Rheumatology, or Inflammatory diseases. Experience with US and EU regulatory requirements. Interaction with authorities like EMA or FDA is a plus.
Skills and Competencies
* Board certification in Dermatology and/or Rheumatology is a plus.
* Strong understanding of clinical drug development and GCP.
* Ability to evaluate, interpret, and present complex scientific data independently.
* Experience working within multidisciplinary teams.
* Excellent organizational, planning, and communication skills.
Work Location
* 2 days a week in Cambridge or Porto offices.
Why Us?
An exciting opportunity!
MoonLake is an innovative biotech company seeking passionate individuals to join our team. We offer a learning environment, impactful projects, flexible work arrangements, and clear career growth paths. Our core values include Stellar Science, Going Beyond, and Unlocking Value, guiding our pursuit of excellence.
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