Biomarker Operations Manager

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early – to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Please visit www.Candeltx.com for additional information.

We are seeking a highly motivated operational manager to join Candel Therapeutics, a rapidly growing Company with an established pipeline.  Reporting to the VP, Experimental Medicine and Immunology, this individual will be working in a dynamic, cross- functional environment spanning early and late clinical development. The Biomarker operational manager will act as a key contributor to the precision medicine efforts of Candel aimed at shaping a personalized approach to treat cancer. Work cross-functionally in a fast-paced environment to manage aspects of biomarker sample collection, consent, handling, and analysis. The successful candidate manages timelines for biomarker projects and provides clear communication across all relevant groups and departments to ensure understanding of the goals, strategy, results dissemination and to ensure appropriate resourcing.

Responsibilities:

  • Operational implementation of biomarker strategy in clinical studies to meet program goals
  • Maintain good communication to share biomarker activities, serving as a key member of study execution teams, providing input to teams and guiding implementation of good clinical practice in collection, storage, analysis of biomarkers
  • Develop sample handling guidelines for sample processing and manage, in collaboration with the clinical team key aspects of biomarker sample collection and consent
  • Work collaboratively in a cross-functional setting to ensure execution of analysis
  • Implementation and oversight of Candel human biobanking in collaboration with clinical and regulatory team
  • Operational support of the work with academic collaborators and CRO on biomarker assays during conduct of clinical trials
  • Implementation and execution of the biomarker testing activities for both early and later phase clinical programs in oncology
  • Author sections of Clinical Study Protocol, Biomarker Strategy documents, Analysis Plans, and Biomarker Study Reports
  • Sample tracking, QC, and management of biomarker data

Requirements:

  • A BS in Biology or related field with 6-8 years’ relevant industry experience or master’s degree in biology with at least 4 years of relevant biotech industry experience.
  • Experience in Biomarker Operations is strongly preferred
  • Excellent written and oral communication skills
  • Organized, detail-oriented and the ability to prioritize and plan to meet deadlines and project plans
  • Knowledge of clinical trial management as it relates to biosample management
  • Knowledge and understanding of general scientific principles as applied to biomarker research, development, and implementation
  • Knowledge of Good Clinical Practices, clinical study design and implementation is a plus

Interested candidates please submit your resume to careers@candeltx.com