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.

EXPERIENCE:

• Minimum of 5 years of professional experience of clinical research within a biotech or pharmaceutical company ideally in Dermatology/Rheumatology/Inflammatory diseases.
• Experience of regulatory drug development requirements in US and EU markets.
• Previous experience of interactions with national supervisory authorities (e.g. EMA, FDA) is a plus.

SKILLS/KNOWLEDGE/BEHAVIOURAL COMPETENCIES:

• Board certified in the field of Dermatology and/or Rheumatology would be a plus and/or relevant professional experience in drug development.
• A good understanding of clinical drug development and GCP.
• Demonstrated ability to independently evaluate, interpret and present complex scientific data.
• Demonstrated ability to critically evaluate complex drug development programs.
• Demonstrated ability to work within a multi-disciplinary team of peers and outside experts
• Possess an organizational and planning talent with excellent communication skills (written or spoken).

Work Location:

• 2 days a week in our brand new Cambridge or Porto Office(s)

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.

ABOUT US

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com

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.