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.
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