Senior Manager, Clinical Operations Lead

1 month ago

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

MoonLake Immunotherapeutics is seeking a highly skilled Senior Manager, Clinical Operations to join our team. As a key member of our clinical development team, you will be responsible for the management of all aspects of clinical study team activities for assigned clinical studies.

Key Responsibilities
  • Lead the clinical study team to deliver successful clinical studies, ensuring timely and within-budget execution.
  • Collaborate with the Director Clinical Operations to develop and implement clinical study plans, ensuring compliance with regulatory requirements and company procedures.
  • Oversee the selection and management of vendors, ensuring high-quality deliverables and timely completion of tasks.
  • Monitor and report on the status of clinical data collection, identifying and addressing any issues or concerns.
  • Develop and review study management plans, ensuring Sponsor oversight of clinical studies in accordance with MoonLake procedures.
  • Review and approve vendor responses to quality assurance audits, ensuring compliance with company SOPs and regulatory requirements.
  • Ensure essential documents allowing the reconstruction of each study are generated, filed, and maintained by or on behalf of MoonLake.
  • Communicate progress and identify risks and issues arising on assigned clinical studies to the Director Clinical Operations and other MoonLake development project team members as appropriate.
Requirements
  • Bachelor's degree in Life Sciences, Nursing, or other healthcare professional equivalent.
  • Minimum of 5 years of clinical operations experience, with increasing levels of responsibility.
  • 5+ years of clinical project management experience on the sponsor side.
  • Substantial experience of managing outsourced global clinical studies.
  • Therapeutic experience in dermatology and rheumatology or relevant indications, ideally experience of biological therapies.
  • Excellent communication skills, able to effectively convey messages across to both internal and external study team members.
  • Highly organized, able to prioritize work, work well under pressure, and meet deadlines.
  • Independent, self-starter with a proactive, problem-solving approach.
  • Ability to work with little or no supervision.
  • High attention to detail at all times.
About Us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory diseases. We continue to make significant progress in our Global Clinical Development Programs, focusing on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis.

We are a dynamic and innovative company, pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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