The Senior Manager, Biosample Management will lead the strategic and operational oversight of the full end-to-end lifecycle for all clinical bio samples supporting pharmacokinetics (PK), anti-drug antibody (ADA)/immunogenicity, and biomarker analyses across Alentis Therapeutics' clinical programs. This role demands deep expertise in managing complex bio sample operations from protocol design through long-term storage and data integration, ensuring sample integrity, regulatory compliance, and high-quality data delivery to inform clinical decisions. The individual will serve as the primary subject matter expert and operational leader, collaborating intensively with Clinical Operations, Translational Medicine, Clinical Pharmacology, Data Management, Clinical Outsourcing, and external partners (CROs, central labs, bioanalytical labs, and specialty vendors) to execute seamless sample management for trials.
Tasks
- This individual will manage the biospecimen lifecycle for Alentis Therapeutics clinical programs through collaboration with Clinical Operations, Data Management, Translational Medicine, Clinical Pharmacology, and external vendors that support all clinical studies.
- Development of biospecimen lifecycle strategies through close collaboration with Clinical Pharmacology, Clinical Study team, and CRO.
- Ensure program level consistency of biospecimen collection, processing, storage, and analysis across studies and programs.
- Contribute to development of study protocols, ICFs, Data Transfer Specifications and other relevant study documents.
- Collaborate with Clinical Operations, Procurement and Quality in the selection and management of central laboratories and specialty bioanalysis labs.
- Manage the creation of complex sample management plans and laboratory documents that ensure the proper collection and storage of samples at clinical sites.
- Manage sample analysis plans and enable study leads to deliver samples to appropriate analysis vendors on time.
- Ensure data transfers between external vendors/CROs and Alentis are initiated, coordinated and managed.
- This requires coordination with scientists, CROs and vendors and ability to interpret clinical study protocols.
- Participate in cross-functional projects and working groups.
- Ability to review and interpret clinical research protocols.
Requirements
- Bachelors degree in Biology, Immunology, Neuroscience, Medical Technology, or related field is recommended with at least 6-8 years of experience in biosample management, clinical operations , or translational medicine OR advanced degree Master or PhD with at least 2-3 years of experience.
- Progressive experience in clinical biosample operations, with deep hands-on expertise in end-to-end management of PK, ADA/immunogenicity, and biomarker samples in biotech/pharma or CRO settings.
- Proven in-depth knowledge of bioanalytical assay requirements and constraints for PK, ADA, and biomarkers, including impacts of pre-analytical variables on data quality.
- Extensive experience developing and reviewing lab manuals, biosample plans, kit designs, data transfer specifications, and related clinical documents; strong understanding of sample logistics, data transfers, reconciliation, and integration with clinical databases.
- Demonstrated success managing external partners (CROs, central labs, bioanalytical vendors) in global clinical trials, including vendor selection/oversight, issue escalation, and performance metrics.
- Thorough familiarity with GCP, regulatory requirements (FDA, EMA), ethical guidelines for biospecimen use (e.g., informed consent, GDPR/HIPAA), and best practices for sample governance/storage.
- Excellent project management, problem-solving, communication, and protocol interpretation skills; ability to influence cross-functional stakeholders and drive operational excellence in matrix environments.
- Proficiency with clinical trial systems (EDC, LIMS, sample tracking tools) and data management processes. Willingness to travel as needed for vendor/site oversight or team collaboration.
Benefits
We offer a competitive compensation package and opportunities for career growth and development. If you are a highly motivated and skilled scientist looking to join a dynamic and innovative team, please submit your CV.
Candidate needs to hold a US work permit.
Originally posted on Himalayas