Senior Bioanalysis Clinical Development Manager

2 days ago


Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time
About the Role

We are seeking a highly skilled and experienced Senior Bioanalysis Clinical Development Manager to join our team at MoonLake Immunotherapeutics. As a key member of our clinical development team, you will be responsible for providing large molecule bioanalytical operational support and expertise to all parties involved in our clinical studies.

Key Responsibilities:

  • Provide technical input and operational accountability for the set-up, validation, and execution of PK/ADA/biomarker testing, with a focus on deliverable timelines.
  • Maintain effective, collaborative relationships with study teams, scientific function key stakeholders, data management groups, internal outsourcing contacts, and contracted vendors.
  • Provide expert input into biological sample collection and handling instructions to ensure they are included in clinical site lab manuals.
  • Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study lifecycle.
  • Assist with review of relevant sections of study-related documents, including central lab SOWs, study protocols/ICFs, bioanalytical reports, etc.
  • Maintain study-specific sample and data flows with stakeholders, manage timelines for bioanalytical labs, and ensure samples are tested according to protocol and data is transferred in the specified format per study team timelines.
  • Assist with monitoring and management of study costs (invoices, PO).
  • Contribute to the set-up of vendor contracts for bioanalysis, working with relevant internal ML contacts.
  • Manage CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines.
  • Provide inputs on CRO performance, escalating concerns as appropriate.

Requirements:

  • BSc. or Master's degree in a relevant life science subject.
  • A minimum of 7-10 years of relevant experience in the pharmaceutical or biotechnology industry.
  • Experience in biopharmaceutical clinical development with hands-on experience in relevant large molecule bioanalytical laboratory techniques and strong working knowledge of GCP/GLP requirements, regulatory bioanalytical guidances, and relevant white papers.
  • Strong verbal and written communication interpersonal skills to develop successful relationships and influence both internal and external stakeholders.
  • Excellent project management and organization skills, with a mature proactive and inclusive approach to problem-solving and trouble-shooting.
  • In-depth and up-to-date knowledge of bioanalytical clinical laboratory techniques and methodologies, especially with regards to PK and immunogenicity testing.
  • Strong computer skills with proficiency in Word, Excel, PowerPoint, and experience with Watson LIMS is desirable.
  • Knowledge of statistical techniques and use of relevant computer software, including bioanalytical laboratory data processing.
  • Goal-oriented, quality-conscientious, and stakeholder-focused.

What We Offer:

  • A dynamic and innovative work environment with a supportive team.
  • Opportunities for career growth and professional development.
  • A competitive salary and benefits package.
  • The chance to work on ground-breaking projects that have the potential to transform global healthcare.

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 are committed to creating novel therapies that elevate treatment horizons, with innovative science, and high quality, always.



  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    {"h1": "Bioanalysis Clinical Development Manager", "p": "At MoonLake Immunotherapeutics, we are seeking a highly skilled Bioanalysis Clinical Development Manager to join our team. As a key member of our clinical development function, you will be responsible for providing large molecule bioanalytical operational support and expertise to all parties involved...


  • Cambridge, Cambridgeshire, United Kingdom School of Clinical Medicine - University of Cambridge Full time

    About the RoleThe School of Clinical Medicine at the University of Cambridge is seeking a highly skilled Senior Programme Manager to join our team. As a key member of our organization, you will play a critical role in the delivery of our clinical research programmes.Key ResponsibilitiesDevelop and implement effective programme management strategies to ensure...


  • Cambridge, Cambridgeshire, United Kingdom School of Clinical Medicine - University of Cambridge Full time

    About the RoleThe School of Clinical Medicine at the University of Cambridge is seeking a highly skilled Senior Programme Manager to join our team. As a key member of our organization, you will play a critical role in the delivery of our clinical research programmes.Key ResponsibilitiesDevelop and implement effective programme management strategies to ensure...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for inflammatory diseases. Our focus is on creating novel treatments that address significant unmet needs in areas like hidradenitis suppurativa and psoriatic arthritis, aiming to improve the lives of...


  • Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    Job DescriptionA leading clinical-stage biotechnology company specializing in oncology is seeking a highly experienced Clinical Trial Manager to join their team at the CK Group - Science, Clinical and Technical. The company has an impressive pipeline of innovative medicines across early phase development.As a Clinical Trial Manager, you will report to the...


  • Cambridge, Cambridgeshire, United Kingdom Relay Therapeutics Full time

    Senior Clinical Operations Manager - Become a key player in our dynamic organizationCompany: Relay Therapeutics is at the forefront of biopharmaceutical innovation, dedicated to creating transformative therapies for patients in need.Position Overview:Oversee the execution of clinical trials from initiation to completion, ensuring adherence to established...


  • Cambridge, Cambridgeshire, United Kingdom Relay Therapeutics Full time

    About Relay Therapeutics Relay Therapeutics is a biotechnology company dedicated to discovering and developing novel therapeutics for patients with cancer and other serious diseases. We leverage our deep understanding of the molecular mechanisms underlying disease to design targeted therapies that address the root causes of illness. Your Role As a Senior...


  • Cambridge, Cambridgeshire, United Kingdom Pfizer Full time

    Job Summary:The Late-Stage Clinical Scientist (non-MD, Senior Manager) is a critical role within Pfizer's Oncology portfolio, responsible for ensuring the scientific integrity and quality of clinical trials. This position requires a strong background in clinical research, with expertise in oncology and a passion for improving patient outcomes.Key...


  • Cambridge, Cambridgeshire, United Kingdom Pfizer Full time

    Job Summary:The Late-Stage Clinical Scientist (non-MD, Senior Manager) is a critical role within Pfizer's Oncology portfolio, responsible for ensuring the scientific integrity and quality of clinical trials. This position requires a strong background in clinical research, with expertise in oncology and a passion for improving patient outcomes.Key...


  • Cambridge, Cambridgeshire, United Kingdom LloydsPharmacy Clinical Homecare Full time

    About the RoleWe are seeking an experienced Registered General Nurse (RGN) with a valid NMC PIN to join our team as a Clinical Homecare Nurse. As a key member of our team, you will be responsible for delivering high-quality clinical care to patients in their own homes, workplaces, or communities.Key ResponsibilitiesDeliver medical treatments such as IV...


  • Cambridge, Cambridgeshire, United Kingdom LloydsPharmacy Clinical Homecare Full time

    About the RoleWe are seeking an experienced Registered General Nurse (RGN) with a valid NMC PIN to join our team as a Clinical Homecare Nurse. As a key member of our team, you will be responsible for delivering high-quality clinical care to patients in their own homes, workplaces, or communities.Key ResponsibilitiesDeliver medical treatments such as IV...


  • Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    Job DescriptionCK Group- Science, Clinical and Technical is seeking a highly experienced Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will play a critical role in the successful execution of our clinical programs.Key Responsibilities:Lead cross-functional study teams to ensure successful clinical trial implementation and protocol...


  • Cambridge, Cambridgeshire, United Kingdom Royal Papworth Hospital NHS Foundation Trust Full time

    About the RoleThe Royal Papworth Hospital NHS Foundation Trust is seeking a highly skilled and experienced professional to lead its Clinical Education and Development team. As the Lead Professional for Clinical Education and Training, you will play a crucial role in driving the development of innovative and effective educational programs for healthcare...


  • Cambridge, Cambridgeshire, United Kingdom Royal Papworth Hospital NHS Foundation Trust Full time

    About the RoleThe Royal Papworth Hospital NHS Foundation Trust is seeking a highly skilled and experienced professional to lead its Clinical Education and Development team. As the Lead Professional for Clinical Education and Training, you will play a crucial role in driving the development of innovative and effective educational programs for healthcare...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Manager, Clinical Operations to join our team at MoonLake Immunotherapeutics. As a key member of our Clinical Operations department, you will be responsible for the management of all aspects of clinical study team activities for assigned clinical studies.Key Responsibilities:Lead the...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Manager, Clinical Operations to join our team at MoonLake Immunotherapeutics. As a key member of our Clinical Operations department, you will be responsible for the management of all aspects of clinical study team activities for assigned clinical studies.Key Responsibilities:Lead the...


  • Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

    About the RoleWe are seeking a highly motivated and experienced senior nurse to join our team as a senior leader in ophthalmology at Cambridge University Hospitals NHS Foundation Trust.As a senior nurse leader, you will be responsible for providing clinical leadership and operational management across all elements of the service, ensuring a professional,...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a pharmaceutical company that specializes in developing innovative medicines for underserved diseases. Our team is dedicated to creating a novel class of medicines, referred to as Bicycle molecules, which have shown promise in targeting specific diseases.We are seeking a highly skilled Senior Clinical Trial Associate to...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a pharmaceutical company that specializes in developing innovative medicines for underserved diseases. Our team is dedicated to creating a novel class of medicines, referred to as Bicycle molecules, which have shown promise in targeting specific diseases.We are seeking a highly skilled Senior Clinical Trial Associate to...


  • Cambridge, Cambridgeshire, United Kingdom Pfizer Full time

    Job Summary:The Late-Stage Clinical Scientist (non-MD, Senior Manager) is a critical role within the Oncology portfolio, responsible for ensuring the scientific integrity and quality of clinical trials. This position requires a strong understanding of clinical procedures, ICH guidelines, and global regulations.Key Responsibilities:Maintain current scientific...