- Provides medical oversight of outsourced study conduct including interactions with CRO medical and drug safety teams
- Sits as a member of the MoonLake Clinical Development Team for named projects and provides advice, guidance, and clinical development expertise on medical related topics to the development project and clinical trial teams
- Works 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.).
- Provides medical input to operational team, including review of documents and plans, e.g CRFs, medical monitoring plans, laboratory manuals, deviation management plans etc.
- Performs medical data review to maintain oversight of emerging efficacy and safety profile as well as potential quality issues for designated trials.
- Works closely with the Drug Safety Officer to support overall surveillance of safety activities related to MoonLake clinical development programmes including, single case medical review, aggregate reporting, signal detection and evaluation, safety related activities associated with regulatory filings, benefit risk assessment and safety risk assessment.
- Works closely with the Drug Safety Officer and CRO teams to organize and support DMC/DSMBs for MoonLake trials/programmes
- Drives development of clinical sections of trial and program level regulatory documents (e.g., protocols, Investigator's Brochure updates, Clinical Study Reports, and responses to Health Authorities).
- May also support clinical development planning activities, working with other functional groups to provide medical input to programme design
- 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
- Thorough knowledge of Good Clinical Practice guidance and regulations for drug development.
- 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
- Good organizational and planning talent with excellent communication skills (written or spoken).
- 2 days a week in our brand new Cambridge or Porto Office(s)
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Medical Director - Cambridge, United Kingdom - MoonLake Immunotherapeutics
Description
Job Purpose
The Medical Director will serve as medical lead for MoonLake's clinical development programs and as medical advisor to the Executive team and all internal functions regarding clinical development activities.
Key Responsibilities:
Your profile
Education: Medical Degree and/or Degree in Sciences
Experience:
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.
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
