Poland-Based Associate Director, Biomarkers & Bioanalytics

Takeda; Ląd; Ibrido; PLN 328.000 - 451.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work policy

Employee benefits package

Descrizione del lavoro

Takeda in Lodz, Poland, seeks an Associate Director, Translational Biomarkers and Bioanalytics to lead bioanalytical strategy and biomarker programs across global trials. You will design and oversee method development, validation, and lifecycle management while ensuring regulatory compliance and data integrity.

You will collaborate with Quality, Regulatory, and cross-functional teams, mentor the TB&B matrix, and guide Poland/EU vendors.

Competenze

• Doctorate or equivalent with extensive pharma industry experience.
• Deep expertise in bioanalytical chemistry and immunology.
• Experience with biomarker technologies and regulatory guidance.
• Experience overseeing Poland/EU labs and CROs.
• Strong communication and cross-functional collaboration.

Mansioni

• Lead bioanalytical and biomarker strategy for global programs.
• Oversee method development, validation, lifecycle management.
• Ensure inspection readiness and data integrity.
• Coordinate with Quality and regulatory teams.
• Mentor TB&B team and Poland/EU vendors.
• Support regulatory submissions and health authority interactions.

Conoscenze

Bioanalytical chemistry

Immunology

Biomarker technologies

Regulatory guidance

Vendor management

Cross-functional collaboration

English proficiency

Formazione

PhD in relevant field

MS in relevant field

BS in relevant field

Strumenti

Mass spectrometry

Bioanalysis platforms

Chromatography

Descrizione del lavoro

Takeda in Lodz, Poland, seeks an Associate Director, Translational Biomarkers and Bioanalytics to lead bioanalytical strategy and biomarker programs across global trials. You will design and oversee method development, validation, and lifecycle management while ensuring regulatory compliance and data integrity.

You will collaborate with Quality, Regulatory, and cross-functional teams, mentor the TB&B matrix, and guide Poland/EU vendors.