Clinical Development Specialist

1 month ago

Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time
Job Overview

MoonLake Immunotherapeutics is seeking a highly skilled Clinical Development Specialist to join our team. As a key member of our Clinical Development department, you will be responsible for providing scientific and clinical development support for our products within the assigned therapy area.

Key Responsibilities:

  • Develop and execute medical and clinical strategies for our products, including protocol development, CRF design, and database conventions.
  • Provide input and participate in writing protocol amendments and SDV plans.
  • Establish glossaries and review database conventions, edit checks, data displays, and case report form summaries.
  • Attend investigator meetings and CRA workshops, and provide science support as needed.
  • Participate in the management of studies, provide training and science input to operation colleagues and study site staff, and support feasibility activities.
  • Review study data, generate queries, and participate in the writing of final study reports.
  • Assist in providing responses to regulatory authorities and ethics committees, and conduct scientific literature research in support of existing or new indications.
Requirements

To be successful in this role, you will need:

  • A Master's degree in science and/or PhD.
  • Experience in the pharmaceutical industry or biotech industry, ideally in a relevant disease area.
  • Experience in designing and conducting large Phase II or Phase III clinical trials.
  • Working knowledge of regulations relating to drug development and promotional activities.
What We Offer

MoonLake Immunotherapeutics offers a dynamic and innovative work environment, with opportunities for career growth and professional development. As a member of our team, you will have the chance to:

  • Contribute to ground-breaking projects that have the potential to transform global healthcare.
  • Work remotely or hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
  • Participate in the development of novel therapies and innovative science.
  • Collaborate with experienced professionals in a supportive and innovative biotech environment.
Our Core Values

We are committed to creating a positive and inclusive work environment that reflects our core values:

  • 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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