(Sr.) Director Bioanalytical Science

Job title:

(Sr.) Director Bioanalytical Science

Company:

TalentMark

Job description

• Research & Development
• Netherlands, Oss
• Fulltime
• V-107720
• Competitive

The Client:
Our client is at the forefront of innovation in immune-mediated inflammatory disease treatment. They are developing therapies that could revolutionize treatment for diseases such as rheumatoid arthritis and hidradenitis suppurativa.The position
As (Sr.) Director Bioanalytical Science, you will be part of the leadership team, overseeing the bioanalytical efforts across all phases of (pre)clinical development. You will work closely with CRO partners, ensuring the development, validation, and implementation of pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity assays for the client’s clinical programs. This role requires managing clinical sample analysis, ensuring timely execution, and compliance with regulatory standards.Your Key Responsibilities:

• Oversee the development and validation of PK, PD, and immunogenicity assays at CRO partner labs, including review and approval of validation plans, specifications, and reports.
• Act as a subject matter expert to resolve assay method issues and ensure quality data.
• Manage clinical sample analysis, collaborating with (pre)clinical teams and external partners to maintain timelines and data integrity.
• Author and review bioanalytical content for clinical and regulatory documentation.
• Standardize processes for cost-effective, high-quality bioanalysis in preclinical and clinical programs.
• Lead and mentor the bioanalytical team, fostering growth and ensuring robust assay support for early- and late-stage trials.
• Collaborate with cross-functional teams to explore new biomarkers related to disease mechanisms.

The Ideal Candidate: The ideal candidate will have:

• An MSc or PhD in biology, pharmacokinetics, biochemistry, or a related field.
• Over 10+ years of relevant experience in CROs, biotech, or pharmaceutical settings.
• A minimum of 5 years of management experience, including staff leadership and budget oversight.
• Expertise in bioanalytical assays, including PK, PD, immunogenicity, and biopotency studies.
• A strong understanding of GLP/GMP regulatory requirements.
• Excellent communication skills and the ability to lead in a dynamic, fast-paced environment.
• A proactive, detail-oriented, and goal-driven approach to bioanalytical science.

Expected salary

Location

Oss, Noord-Brabant

Job date

Sat, 12 Oct 2024 22:10:53 GMT

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