The Senior Manager, Bioanalysis Clinical Development, provides full bioanalytical development, operational and logistical support and expertise to all parties (internally/externally) involved in MoonLake’s late stage clinical studies. Ensures the timely and efficient delivery of all bioanalytical operational aspects for clinical trials in accordance with applicable quality and regulatory standards.
Major Accountabilities Acts as Bioanalytical Lead in clinical study teams. Maintains effective, collaborative relationships with clinical operations teams, key stakeholders, data management groups, consultants and contracted vendors (both bioanalytical CROs and Central Labs). Provides expert review of relevant sections of clinical study documents (i.e., study protocols/consent forms, central lab set-up, data transfer specifications, bioanalytical plans, etc.) and input into regulatory submissions. Acts as subject matter expert for biological sample collection and handling, and provides input to clinical study laboratory manuals. Actively monitors and facilitates resolution of clinical study sample and data discrepancies, and disposition of samples throughout the study lifecycle. Maintains study-specific sample and data flows with stakeholders, manages timelines for bioanalytical labs, ensures samples are tested according to protocol and regulatory guidance, and data is transferred in the specified format per study team timelines. Executes vendor selection and contracts for bioanalysis, working with relevant internal ML contacts. Manages CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provides inputs on CRO performance, escalating concerns as appropriate. Assists with monitoring and management of study costs (invoices, PO). Assists with training and participates in organizational initiatives to support business needs. Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation). Your profile
Education: BSc. or Master’s degree in relevant life science subject Experience:
A minimum of 5-10 years experience managing clinical bioanalysis studies within a biopharmaceutical development company (*applications from individuals with only contract bioanalytical laboratory experience will not be considered) Experience in biopharmaceutical clinical development of relevant large molecule bioanalytical laboratory techniques and strong working knowledge of GCP/GLP requirements, regulatory bioanalytical guidances, and relevant white papers. Preferred experience in PK and immunogenicity regulatory document preparation, e.g. BLA modules. Skills/knowledge/behavioural competencies:
Strong verbal and written communication interpersonal skills to confidently develop successful relationships and influence both internal and external stakeholders. Excellent hands-on project management and organization skills. A mature proactive and inclusive approach to problem solving and trouble-shooting. In-depth and up-to-date knowledge of large molecule bioanalytical clinical laboratory techniques and methodologies. Working knowledge or better of clinical pharmacology as applicable to PK and immunogenicity, e.g. PopPK, integrated immunogenicity summaries. Strong computer skills with proficiency in Word, Excel, PowerPoint. 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. Why us?
An exciting job opportunity awaits you! 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
Major Accountabilities Acts as Bioanalytical Lead in clinical study teams. Maintains effective, collaborative relationships with clinical operations teams, key stakeholders, data management groups, consultants and contracted vendors (both bioanalytical CROs and Central Labs). Provides expert review of relevant sections of clinical study documents (i.e., study protocols/consent forms, central lab set-up, data transfer specifications, bioanalytical plans, etc.) and input into regulatory submissions. Acts as subject matter expert for biological sample collection and handling, and provides input to clinical study laboratory manuals. Actively monitors and facilitates resolution of clinical study sample and data discrepancies, and disposition of samples throughout the study lifecycle. Maintains study-specific sample and data flows with stakeholders, manages timelines for bioanalytical labs, ensures samples are tested according to protocol and regulatory guidance, and data is transferred in the specified format per study team timelines. Executes vendor selection and contracts for bioanalysis, working with relevant internal ML contacts. Manages CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provides inputs on CRO performance, escalating concerns as appropriate. Assists with monitoring and management of study costs (invoices, PO). Assists with training and participates in organizational initiatives to support business needs. Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation). Your profile
Education: BSc. or Master’s degree in relevant life science subject Experience:
A minimum of 5-10 years experience managing clinical bioanalysis studies within a biopharmaceutical development company (*applications from individuals with only contract bioanalytical laboratory experience will not be considered) Experience in biopharmaceutical clinical development of relevant large molecule bioanalytical laboratory techniques and strong working knowledge of GCP/GLP requirements, regulatory bioanalytical guidances, and relevant white papers. Preferred experience in PK and immunogenicity regulatory document preparation, e.g. BLA modules. Skills/knowledge/behavioural competencies:
Strong verbal and written communication interpersonal skills to confidently develop successful relationships and influence both internal and external stakeholders. Excellent hands-on project management and organization skills. A mature proactive and inclusive approach to problem solving and trouble-shooting. In-depth and up-to-date knowledge of large molecule bioanalytical clinical laboratory techniques and methodologies. Working knowledge or better of clinical pharmacology as applicable to PK and immunogenicity, e.g. PopPK, integrated immunogenicity summaries. Strong computer skills with proficiency in Word, Excel, PowerPoint. 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. Why us?
An exciting job opportunity awaits you! 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
