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.