Manager Clinical Biomarker Operations

Adaptimmune

Philadelphia, PA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 04/12/2021
  • Website: adaptimmune.com
  • Company Address: 351 Rouse Boulevard , Philadelphia, PA , 19112

About Adaptimmune

Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.

Job Description

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.

Key Responsibilities

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

Required

  • Bachelor’s degree in Life Sciences, healthcare-related or equivalent
  • 5+ years’ experience with Clinical Biomarker operations in biotech or pharma industry
  • Scientific knowledge in biomarkers and drug development, and clinical trial methodology
  • Extensive clinical or biological laboratory experience processing and analyzing biological samples
  • Demonstrated experience in global vendor management
  • In depth knowledge of ICH, GCP, GLP, CAP and CLIA regulations, data management, regulatory and legal issues/processes as they relate to biomarker samples
  • Knowledge of LIMS systems
  • Strong project management, planning, organizational and time management skills required
  • Critical reasoning skills including the identification and resolution of complex problems
  • Excellent communication and professional interpersonal skills, including influencing skills, problem solving, and conflict resolution
  • Detail oriented with the ability to manage multiple competing priorities
  • Prior experience with training and mentoring colleagues

Desirable

  • Advanced degree (MS or PhD)
  • Project management certification
  • Experience in both early and late phase global programs
  • Experience in managing staff

 

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.