Medical Director
Posted 11 hours 58 minutes ago by MoonLake Immunotherapeutics
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.
- 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.
- 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.
- 2 days a week in Cambridge or Porto offices.
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.