Medical Director

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 the MoonLake organization. This is a hands-on role working with experienced colleagues as part of a cross-functional team.

Major Accountabilities

Provides medical strategic input to the assigned project or section of a clinical program including:

• Providing medical oversight of outsourced study conduct, including interactions with CRO medical and drug safety teams
• Providing medical input to operational teams, including review of documents and plans, e.g., CRFs, medical monitoring plans, laboratory manuals, deviation management plans, etc.
• Performing medical data review to oversee efficacy and safety profiles, as well as potential quality issues for designated trials.
• Collaborating with the Drug Safety team to evaluate Serious Adverse Events and develop Safety Management, Pharmacovigilance, and Risk Management Plans.
• Ensuring adequate safety oversight and medical monitoring of trials.
• Organizing and supporting DMCs and ensuring compliance with ICH-GCP and other regulatory standards.
• Driving the development of clinical sections of regulatory documents such as protocols, Investigator's Brochure updates, safety updates, Clinical Study Reports, and responses to health authorities.
• Working cooperatively with Clinical Operations and CROs to execute programs, including study start-up, team meetings, data reviews, and training material development.
• Creating and approving training materials and processes.

Your profile

Education: Medical Degree and/or Degree in Sciences

Experience:

• At least 5 years of clinical research experience within biotech or pharma, ideally in Dermatology, Rheumatology, or Inflammatory diseases.
• Knowledge of regulatory drug development requirements in US and EU markets.
• Experience interacting with authorities such as EMA and FDA is a plus.

Skills/Knowledge/Behavioral Competencies

• Board certification in Dermatology and/or Rheumatology or relevant drug development experience is a plus.
• Strong understanding of clinical drug development and GCP.
• Ability to evaluate, interpret, and present complex scientific data independently.
• Capacity to critically assess drug development programs.
• Ability to work effectively within multidisciplinary teams.
• Excellent organizational, planning, and communication skills.

Work Location

• 2 days a week in our Cambridge or Porto offices.

Why us?

An exciting job opportunity awaits you!

MoonLake is a dynamic and innovative company pushing the boundaries of possibility. We seek passionate individuals to join our team.

What we offer:

• Learning Environment: Grow alongside experienced professionals in a supportive biotech environment.
• Impactful Work: Contribute to groundbreaking projects with the potential to transform healthcare.
• Flexibility and Balance: Enjoy remote/hybrid work and a healthy work-life balance.
• Career Growth: Opportunities for advancement and skill development.

Our Core Values

We seek MoonLakers who embody our values:

• We do Stellar Science: Creating innovative, high-quality therapies.
• We go beyond: Challenging norms boldly and positively disrupting our field.
• We unlock value: Creating long-term value for investors and communities.