Associate director Bioanalytics

Introduction

For the expansion of the bioanalytical team, we are looking for a (Associate) Director Bioanalytics, with profound experience in late-stage drug development of large molecules.

You will conduct and lead bioanalytical support in all aspects for one of the indication franchises.

The Bioanalytical experts are responsible for the design of the bioanalytical strategy of their assigned projects, the commission of workpackages to bioanalytical vendors, the oversight and compliant conduct of bioanalytical study phases and the timely delivery of data. They are responsible for the correctness of bioanalytical sections of regulatory documents and the investigator brochure.

You will be the key representative of the bioanalytical team in regulatory submissions team meetings, working closely with the senior / principal bioanalytical scientists in the clinical development teams to ensure a harmonized approach within and across franchise(s). Also be responsible to oversee the bioanalytical contributions to regulatory documents and serve as a management reviewer and approver.

You are considered to be an expert bioanalytical scientist with deep understanding of scientific and regulatory requirements of bioanalytical method development and validation. A focus expertise on the fit for purpose characterisation of biomarker assays will be preferred.

Job description

• Oversees the bioanalytical contributions in the review and writing regulatory documents and performs management review. Collaborate with internal stakeholders such as medical writer and Clinical pharmacology.
• Performs management review and approval of bioanalytical documents
• Review and provide input in clinical trial documents
• Contribute in interactions with regulatory agencies
• Responsible for developing bioanalytical strategies in collaboration with bioanalytical team, project and clinical teams.
• Together with sourcing manager and program manager, responsible for the timely commission and execution of bioanalysis at the bioanalytical vendors. Participate in vendor governance meetings where appropriate
• In collaboration with program manager, ensure correct financial and project planning
• In collaboration with Head of bioanalytics, ensure appropriate resource planning for the franchise(s)
• Takes initiative, follow up and troubleshooting of the methods
• Studying relevant literature, being aware of scientific and bioanalytical developments and how these might apply to the argenx clinical development programs
• Presenting results and findings at internal multidisciplinary project / clinical teams
• Coach team members

Profile

Offer

A competitive compensation package with extensive benefits

Exposure to all aspects of pre-clinical and clinical development in the company, but also with external vendors, contract partners and the scientific world

A work environment in a dynamic, rapidly growing biotech company