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(Sr.) Director of Bioanalytical Science
Summary
The (Sr.) Director Bioanalytical Science has the responsibility of providing bioanalytical leadership for all phases of (pre)clinical development for Citryll’s biological therapeutic programs. In this position you will work closely with CRO partners, and provide scientific oversight, for development and validation of PK, PD and immunogenicity assays to support a diverse portfolio of clinical programs. You will collaborate with (pre)clinical study team and external partners and be responsible for managing clinical sample analysis at all stages of development, ensuring that bioanalytical studies are conducted in a timely manner and in compliance with scientific principles and global regulatory standards. In this position you have the responsibility of authoring and reviewing bioanalytical sections of (pre)clinical and regulatory documents.
Responsibilities
- Responsible for scientific oversight and the development and validation of PK, PD and immunogenicity and biopotency assays at CRO partner labs. Review and approve validation plans, method specifications and validation reports
- Act as subject matter expert and assist/facilitate resolution of assay method issues.
- Responsibility for closely collaborating with (pre)clinical study teams in managing sample analysis at CRO labs. Responsible and accountable for bioanalytical study timeline and oversight of data quality
- Author and review of bioanalytical contents needed for clinical study and regulatory communication and submission
- Establish, maintain and improve standardized working processes to ensure uniform and quality driven cost-effective practices in (pre)clinical bioanalysis.
- Lead the Bioanalytical team responsible for the development of robust bioassays to support early and late-stage clinical trials
- Mentor, coach and inspire (junior) research associates and scientists to enable their growth in professional and personal development
- Good understanding of GLP and GMP regulatory requirements
- Collaborate closely with the Mode-of-Action Team Lead in the hunt for potential new disease related biomarkers
Qualifications & Experience
- MSc/PhD in biology, pharmacokinetics, biochemistry, or a related scientific discipline.
- Minimum of 10 years relevant (laboratory) experience in a contract research organization (CRO), biotech, or pharmaceutical environment in a similar role
- 10+ years of management experience, including staff management and career development, and budget related responsibility
- Expertise in Bioanalysis and in the design, conduct, and interpretation of Pharmacokinetic (PK), Pharmacodynamic (PD), Immunogenicity studies, biopotency assay and (non) cell based neutralizing ADA assays is required
- Strong communication skills, attention to detail, and the ability to adapt in a dynamic team environment are essential for success
- Good understanding of compliance with GLP/GMP regulatory requirements
- You are an accurate, flexible, quality-minded person with a proactive attitude and can work well in a team, as well as independently. You are goal oriented and result driven. You take ownership and can present your work