Job description

The Director Drug Safety/PV serves as the scientific safety leader for MoonLake’s clinical development programs including different indications and lead, manage and oversee all safety related activities for contracted vendors and in close collaboration with authorities and provides optimal guidance to all relevant internal departments and functions regarding the safety strategies (Clinical development and CMC) and all operational activities.

• Responsible for MoonLake’s Safety related SOPs, their maintenance, and updates.
• Responsibilities include operational safety/PV activities w/ overall surveillance of safety activities, single case medical review, its QC and submission, aggregate reporting, signal detection and evaluation, safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk assessment
• Is key contact within MoonLake for all safety related topics and questions, supports team wide compliance with safety governance rules
• Responsible for the integration, analysis, and clinical interpretation of safety information from all sources, including preclinical through future post-marketing, as well as internal and external data.
• Responsible to oversee the validation of safety databases systems, and the maintenance of the validation status for computerized systems used to perform safety/PV activities.

Experience & personal attributes

At MoonLake, we use our collective unique experience, expertise, and dedication to develop novel therapies in the smartest way, to unlock value for the company.

The Director Drug Safety/PV´ unique experience would come from:

• Sound knowledge in safety databases, familiarity with safety data entry platforms, adverse event collection process and case processing
• Extensive experience w/ MedDRA terminology and coding
• Expertise in preparing clinical safety assessments and regulatory reports/ submissions involving safety information – to include NDA submission documents
• Strong experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
• Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs

We value people that are:

• Accountable and responsible for their area of expertise and the team as a whole
• Able to balance results delivery with scientific precision, ethical rigor and transparency
• Excited about stepping up to new challenges at speed
• Courageous in thinking of how the team can achieve the impossible
• Driven to results with executional mastery and integrity, for the benefit of our community

MoonLake is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Agencies: External recruitment firms are an important component of our talent acquisition strategy at MoonLake; we value the partnerships built with our vendors. As a policy, we do not accept unsolicited resumes from external recruitment firms. All resumes submitted by external recruitment firms should be directed to dedicated career email address: career@moonlaketx.com. Engagement with external firms requires that a signed MoonLake Agency agreement be on file. External agency submissions that are sent to any employee or hiring manager, outside of the outlined process, will be deemed unsolicited and no fee will be paid in the event that the candidate is hired. Credit will be attributed as a referral or hired through other means.