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Clinical Science Lead

2 weeks ago

Ottawa, Ontario, Canada MoonLake Immunotherapeutics Full time

Company Overview


MoonLake Immunotherapeutics is a dynamic and innovative biotech company pushing the boundaries of possibility.



Job Description


The Clinical Science Specialist will provide leadership and management within Clinical Development, to support scientific and clinical development for products within MoonLake Immunotherapeutics assigned therapy area.



Key Responsibilities:



  • Support development and execution of medical & clinical strategy for MoonLake Immunotherapeutics product(s).



  • Assist in protocol development and be fully responsible for specific sections of the protocol.



  • Provide input and participate in writing of protocol amendments as needed.



  • Contribute to CRF design and provide guidelines for project specific and clinically relevant laboratory parameters.



  • Review and provide input for SDV plans based on protocol specifications.



  • Establish glossaries, review database conventions, edit checks, data displays, and case report form summaries.



  • Attend and provide science support for investigator meetings and CRA workshops.



  • Participate in the management of studies and provide training and science input to operation colleagues and study site staff.



  • Support feasibility activities with operational colleagues.



  • Contribute to ongoing review of study data including reconciliation across databases and query generation.



  • Participate in the writing of final study reports and NDA documentation.



  • Provide response to regulatory authority and ethic committees.



  • Conduct scientific literature research in support of existing or new indications for the assigned products.



  • Stay up-to-date with current pharmaceutical regulations, guidelines and practices.





Your Profile


We are seeking a highly qualified individual with a Master's degree in science and/or PhD.



Requirements:



  • Experience in pharmaceutical industry/Biotech industry, ideally in relevant disease area.



  • Experience in designing and conducting large Phase II or Phase III clinical trials.



  • Experience working in drug development of large Phase II or Phase III/IIIb.



  • Strong team player with ambitious attitude and ability to align with companies vision and values.



  • Working knowledge of regulations relating to drug development and promotional activities.





Benefits


MoonLake Immunotherapeutics offers a supportive and innovative environment with opportunities for career growth and professional development.



What We Offer


An opportunity to learn and grow alongside experienced professionals in a dynamic and innovative biotech company.


Impactful work contributing to ground-breaking projects that have the potential to transform global healthcare.


Flexibility and balance with remote/hybrid work arrangements and a healthy work-life balance.


Career growth with a clear path for progression and the chance to take on more responsibilities.


A dynamic and innovative company culture with three core values: Stellar Science, Beyond, and Unlock Value.