Medical Director

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 profileEducation:

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 ValuesWe 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

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