Clinical Serology Project Manager (m/f)

Description

• Support global objectives of Clinical Development and Head of Clinical Serology in the Vaccine Business Unit (VBU)
• Manage and oversee timely delivery of clinical serology assays of appropriate quality to assess clinical endpoints in clinical studies of vaccine development, as based on the clinical assay strategy in accordance with regulatory requirements e.g. EMA/FDA guidelines and quality standards, e.g. Good Laboratory Practice
• Collaborate with academia, bio-analytical lab vendors and in-house labs for assay development
• Lead serology approach by establishing the Serology Plan reflecting the serology needs of a clinical study, managing operations thereof and seeking for alignment with the Clinical Trial Team
• Support the drafting and execution of contracts and work orders with bio-analytical vendor labs, based on Serology Plans
• Oversee and manage the serology budget of clinical sample testing for all studies of the program
• Oversee the review and execution of the Lab Manual for sample management, provided by the contracted vendors
• Partner with the Clinical Delivery Manager to implement the Serology Plan for the clinical endpoints in studies, in compliance with GCP-ICH guidelines
• Inform the Quality Assurance team about quality deviations of sample management and clinical sample testing
• Oversee all timelines of clinical assays from the development and validation of assays to the delivery of QC/QA results of clinical sample testing to statistic and data management

• MS degree in life sciences or PhD in life sciences
• Profound laboratory experience
• In-depth working experience in the pharmaceutical industry, preferably with vaccines
• Experience and demonstrated success in the development and validation and clinical sample testing by using serology assays and other bio-analytical methods (including working with blood borne pathogens and human serum)
• Background in virology (e.g. flavivirus, alphaviruses, calicivirus) and vaccine development desirable, as well as in immunology and molecular biology
• Basic understanding of GMP, GCP-ICH and GCLP guidelines
• Understanding of the vaccine development process and experience in the support of clinical trial teams
• Fluency in English, in both oral and written form
• Strong communication, strategic, analytical problem-solving and interpersonal skills