Medical Director

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. Additionally, this role acts as the internal medical expert and will serve as a medical resource for the team and contribute 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 team, including review of documents and plans, e.g CRFs, medical monitoring plans, laboratory manuals, deviation management plans etc.
• Performing medical data review to maintain oversight of emerging efficacy and safety profile as well as potential quality issues for designated trials.
• Working closely with the Drug Safety function to evaluate Serious Adverse Events and to develop Safety Management Plans, Pharmacovigilance Plans and Risk Management Plans.
• Ensuring adequate safety overview and medical monitoring of the trial.
• Organizing and support DMCs as well as you assure compliance with ICH-GCP and other regulatory requirements
• Driving development of clinical sections of trial and program level regulatory documents (e.g., protocols, Investigator’s Brochure updates, safety updates, Clinical Study Reports, and responses to Health Authorities).
• Working cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. participate in study start up, and cross-functional team meetings, perform data and coding reviews; draft / present clinical slides for Investigators Meeting, Advisory Boards and therapeutic / monitor training etc.)
• Creating and approving internal and external training materials and processes.

Your profile

Education : Medical Degree and / or Degree in Sciences

Experience :

Skills / knowledge / behavioural competencies :

Work Location :

Why us?

An exciting job opportunity awaits you!

MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer :

Learning Environment : An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

Impactful Work : Contribute to ground-breaking projects that have the potential to transform global healthcare.

Flexibility and Balance : Work remotely / hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.

Career Growth : A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.

Our Core Values

We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence :

We do Stellar Science : We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.

We go beyond : We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.

We unlock value : We aspire to create long-term value for investors and communities.

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