Senior Bioanalysis Clinical Development Manager
2 days ago
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.
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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...
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