$80K — $100K *
The Biomarkers and Companion Diagnostics team at Adaptimmune supports the clinical development of novel autologous T cell therapies for cancer. We use relevant biomarkers for patient selection, patient monitoring (response and safety) and long-term follow-up of the patients. Our team is responsible for designing and implementing biomarker and companion diagnostic strategies, designing and implementing biomarker assays into clinical studies, interpreting biomarker data and developing companion diagnostic (CDx) assays, and in collaboration with our regulatory team, supports filing and registration activities.
We are seeking a highly experienced clinical biomarkers operations manager to execute clinical biomarker plans for our programs in oncology. This individual will work collaboratively with Clinical Biomarker Scientists and will work across several clinical teams and TCR programs managing productive external vendor collaborations and delivering regulatory compliant biomarker data within program timelines. The position requires working in close partnerships across various functions including Clinical Development, Clinical Operations, Data Management, Biometrics, Human Biological Sample Management (HBSM) and Information Management.
Ensures the timely and efficient delivery of all biomarker operational aspects across all clinical trials: accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from collection, analysis, data delivery and final sample disposition with support from the HBSM group.
Supports the identification and selection of biomarker vendors in collaboration with cross-function stakeholders; ensuring appropriate cross-functional input is incorporated into the scope of work.
Implements biomarker testing within clinical trials and performs ongoing biomarker vendor management including development and oversight of contracts, scopes of work, and performance management.
Develops and provides operational input and recommendations into all study related documentation and processes, and ensures collection, delivery, and analysis of samples in compliance with these documents as well as ICH GCP.
Actively partners with cross-functional stakeholders to oversee and coordinate biomarker data format and delivery timelines.
Maintains oversight of biomarker vendor performance, monitors issues and their resolution, and coordinates any corrective action in collaboration with Compliance.
Files biomarker related documents within the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’.
Provides study level updates to clinical study teams and biomarker teams including sample collection, assay status and analysis updates; communicates any variances and implements contingencies in consultation with key stakeholders.
Participates in committees and work streams that support process improvements.
Manages clinical biomarker staff
QUALIFICATIONS & EXPERIENCE
Valid through: 4/21/2021