Overview
Medical Director role at MoonLake Immunotherapeutics (NASDAQ: MLTX)
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. This role acts as the internal medical expert and will serve as a medical resource for the team to 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: medical oversight of outsourced study conduct, interactions with CRO medical and drug safety teams
* Provides medical input to the operational team, including review of documents and plans (e.g., CRFs, medical monitoring plans, laboratory manuals, deviation management plans)
* Performs medical data review to maintain oversight of emerging efficacy and safety profile and identify potential quality issues for designated trials
* Works with the Drug Safety function to evaluate Serious Adverse Events and to develop Safety Management Plans, Pharmacovigilance Plans, and Risk Management Plans
* Ensures adequate safety overview and medical monitoring of the trial
* Organizes and supports DMCs and ensures compliance with ICH-GCP and regulatory requirements
* Drives development of clinical sections of trial and program-level regulatory documents (e.g., protocols, Investigator’s Brochure updates, safety updates, Clinical Study Reports, responses to Health Authorities)
* Works with Clinical Operations and designated CROs to execute programs (e.g., study start-up, cross-functional team meetings, data and coding reviews; draft/present clinical slides for Investigators Meetings, Advisory Boards, and therapeutic/monitor training)
* Creates and approves internal and external training materials and processes
Your profile
Education: Medical Degree and/or Degree in Sciences
Experience:
* Minimum of 5 years of professional experience in clinical research within a biotech or pharmaceutical company, ideally in Dermatology/Rheumatology/Inflammatory diseases
* Experience with regulatory drug development requirements in US and EU markets
* Previous experience interacting with national supervisory authorities (e.g., EMA, FDA) is a plus
Skills/knowledge/behavioural competencies:
* Board certified in Dermatology and/or Rheumatology would be a plus or relevant drug development experience
* Good understanding of clinical drug development and GCP
* Ability to independently evaluate, interpret and present complex scientific data
* Ability to critically evaluate complex drug development programs
* Ability to work within a multi-disciplinary team of peers and outside experts
* Strong organizational and planning skills with excellent communication (written or spoken)
Work Location
* 2 days a week in our Cambridge or Porto Office(s)
Why us?
An exciting job opportunity awaits you!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility. 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 biotech environment.
* Impactful Work: Contribute to ground-breaking projects with potential to transform global healthcare.
* Flexibility and Balance: Hybrid/work-from-home options with a healthy work-life balance.
* Career Growth: Clear path for progression and increased responsibilities as you develop your skills.
Our Core Values
We look for MoonLakers who embody our three core values:
* We do Stellar Science: Pursue novel therapies with innovative science, high quality, and excellence.
* We go beyond: Be positively disruptive and bold in challenging norms.
* We unlock value: Create long-term value for investors and communities.
* Seniority level: Director
* Employment type: Full-time
* Job function: Research
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