The Life Science Career Network
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Our client develops innovative therapeutic antibodies in immuno-oncology fighting cancer cells by reactivating the body's own defense mechanisms.
For the next possible date we are looking for a Bionalytics Unit Head to step into a permanent position.
Bioanalytics Unit Head (f/m/d)
• Lead bio-analytics unit within the company’s Preclinical Development department
• Drive conceptualization and execution of the bio-analytical strategy for all preclinical & clinical development programs
• As such drive development of bio-analytical assays (PK, ADA, NAb and biomarker assays) for clinical and non-clinical applications in house or at Contract
Research Organizations (CROs); ensure availability of data as required per development plans
• Ensure transfer of assays to CROs including organization and monitoring of assay development/validation, as well as conduct of bioanalytical studies in
collaboration with CROs
• Ensure regulatory adequacy of bio-analytical program strategies, perform data analysis, drive data-based internal decision making and report results in
regulatory documents (e.g. study reports, IND, IB and BLA/MAA)
• Lead and mentor team members in bio-analytical aspects
• Act as bio-analytical representative in cross-functional global program teams as required
• Degree in Life Sciences (PhD) with at least 5 years of industrial experience in development of biologics covering the described areas
• In-depth knowledge in the areas of assays development and validation (Pharmacokinetics, Immunogenicity and Biomarkers) using MSD®, LC-MS/MS and FACS
based assays incl. recent and upcoming development of regulatory guidelines
• Track record of leading conceptualization of bioanalytical program strategies, ideally as line manager
• Track record of excellence in the area of CRO liaison incl. experience in managing bioanalytical studies according to GLP/GCP
• Experience in regulatory agency interactions, e.g. Pre-INDs, INDs or market authorizations
• Demonstrated ability to work independently on multiple projects in parallel
• Strong communication and presentation skills
• Ability to conduct multiple projects delivering agreed milestones adhering to timelines and budget
• Excellent team player
• Fluent in oral and written English, additional German language skills would be a plus
• The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and friendly team.
• Above average payment
• Company shares in the form of stock options
• Working from the home office
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.