Director, Clinical Bioanalysis
Director, Clinical Bioanalysis 1348596
Location: Cambridge, MA (Hybrid/Remote)
Science: Antibody Drug Conjugates
Therapeutic Area: Oncology
Job Overview: This position will be responsible for overseeing and managing bioanalytical outsourcing activities for clinical PK and Immunogenicity for our ADCs. As part of the Clinical Pharmacology Group, you will plan and manage PK/immunogenicity sample collection, shipment, storage and assay-related activities, interact with different partner CROs, and track all relevant timelines for the ongoing clinical trials.
Responsibilities:
- Operational leadership of clinical bioanalytical studies and assays, being the primary point of contact with our partner CROs for all clinical Bioanalysis samples, liaising with these CROs for effective planning and operational conduct of the studies.
- Provide bioanalytical operational expertise to internal and external clinical trial teams, implementing and executing bioanalytical strategies in all phases of the drug development pipeline.
- Operational oversight of clinical CRO partners.
Qualifications:
- Ph.D. in relevant discipline, with several years of related experience
- Experience in bioanalytical method development, validation, and sample analysis in large molecules and small molecule analysis by LC-MS/MS required
- Experience either working in a CRO or managing at the outsourced work conducted by CROs
- Previous experience in a GLP, GCP, and/or CLIA compliant bioanalytical lab environment is required
- Experience in clinical trial operation including protocol review, laboratory manual development, sample collection/shipment/processing condition, and device/lab supply is required
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.