Job Purpose
The Clinical Science Specialist will provide appropriate leadership and management within Clinical Development, to provide scientific and clinical development support for products within MoonLake Immunotherapeutics assigned therapy area. Key responsibilities: Support development and execution of medical & clinical strategy for MoonLake Immunotherapeutics product(s), including but not limited to: Assist in protocol development in general and be fully responsible for specific sections of the protocol Provide input and participate in writing of protocol amendments as needed Provide input for CRF design. Provide guidelines for project specific and clinically relevant laboratory parameters. Provide input and review of SDV plans based on protocol specifications. Establish glossaries, review and provide input for database conventions, edit checks, data displays, and case report form summaries. Attend and provide science support for investigator meetings and CRA workshops. May accompany operations personnel on site visits as agreed with clinical operations. 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 Participate in the ongoing review of study data including reconciliation across databases and query generation. Participate in the writing of final study reports. Participate in NDA documentation and preparation of materials for use in presentation. Assist in providing response to regulatory authority and ethic committees. Conduct scientific literature research in support of existing or new indications for the assigned products. Remain up to date with current pharmaceutical regulations, guidelines and practices to ensure consistent best practices across all activities including therapeutic knowledge. Your profile
Education:
Master’s degree in science and/or PhD Experience: 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 2 or Phase III/ IIIb Skills/knowledge/behavioural competencies: Team player, ambitious and can align with companies vision and values. Working knowledge of regulations relating to drug development and promotional activities Work Location: 2 days a week in our brand new Cambridge or Porto Office(s) Why us?
An exciting job opportunity awaits! 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.
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The Clinical Science Specialist will provide appropriate leadership and management within Clinical Development, to provide scientific and clinical development support for products within MoonLake Immunotherapeutics assigned therapy area. Key responsibilities: Support development and execution of medical & clinical strategy for MoonLake Immunotherapeutics product(s), including but not limited to: Assist in protocol development in general and be fully responsible for specific sections of the protocol Provide input and participate in writing of protocol amendments as needed Provide input for CRF design. Provide guidelines for project specific and clinically relevant laboratory parameters. Provide input and review of SDV plans based on protocol specifications. Establish glossaries, review and provide input for database conventions, edit checks, data displays, and case report form summaries. Attend and provide science support for investigator meetings and CRA workshops. May accompany operations personnel on site visits as agreed with clinical operations. 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 Participate in the ongoing review of study data including reconciliation across databases and query generation. Participate in the writing of final study reports. Participate in NDA documentation and preparation of materials for use in presentation. Assist in providing response to regulatory authority and ethic committees. Conduct scientific literature research in support of existing or new indications for the assigned products. Remain up to date with current pharmaceutical regulations, guidelines and practices to ensure consistent best practices across all activities including therapeutic knowledge. Your profile
Education:
Master’s degree in science and/or PhD Experience: 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 2 or Phase III/ IIIb Skills/knowledge/behavioural competencies: Team player, ambitious and can align with companies vision and values. Working knowledge of regulations relating to drug development and promotional activities Work Location: 2 days a week in our brand new Cambridge or Porto Office(s) Why us?
An exciting job opportunity awaits! 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.
#J-18808-Ljbffr
