Manager, Clinical Biomarker Operations

POSITION SUMMARY

You will ensure quality planning, implementation, and execution of biomarker operations through the specimen lifecycle, including strategic set-up of central lab operations, study start-up, logistics, and clinical sample management from collection through testing and final sample disposition. 

POSITION RESPONSIBILITIES

• Operational execution of the biomarker strategy:
  • Plan and coordinate operational activities through the biomarker specimen lifecycle.
  • Set up Central lab and Analytical labs as they pertain to biomarker collections
  • Prepare and review of clinical study documents such as lab specification documents, sample management plans, and laboratory manuals.
  • Support vendor selection and contract review
  • Develop site trainings for biomarker collections
  • Manage biomarker specimens from collection through testing and final disposition.
  • Ensure compliance with Clinical Protocol and Informed Consent
  • Maintain specimen chain of custody
  • Organize and oversee the collection, shipping and proper storage and maintenance of clinical specimens.
  • Resolve and/or triage specimen queries from sites or vendors.
  • Manage documentation and filing related to sample disposition activities.
• Support implementation and maintenance of specimen tracking system
• Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study level execution of scientific and operational needs.
• Support internal vendor leads with Central lab oversight, change management and process improvements.
• Identify, develop, and implement risk mitigation strategies associated with lab vendors as needed across programs.

QUALIFICATIONS / SKILLS

• BA/BS in relevant field and 4 + years' clinical operations experience and a thorough knowledge of Central and Analytical Lab(s) processes
• Experience in lab operations and biospecimen management
• Strong project management and time management skills including strong prioritization skills
• Proficiency with data sets and Excel, understanding of data relationships and metadata
• Experience overseeing vendors and communicating with experts to drive quality deliverables
• Experience  performing detailed, quality and accurate work with minimal oversight
• Strong written/verbal communication skills
• Experience identifying opportunities for efficiency improvements and simplification,
• Experience working collaboratively with many diverse stakeholders
• Experience and success working in a dynamic environment, addressing challenges and solving problems
• Strong learning agility including experience learning new skills, new technical information, standards, regulations, tools, methods or software  

PREFERRED QUALIFICATIONS:

• MSc in Life Science and 2+ years clinical operations experience and a thorough knowledge of Central and Analytical Lab(s) processes
• PMP certification
• Biobanking, sample tracking and handling experience
• LIMS (Laboratory Information Management System) experience
• Working knowledge of the clinical drug development process
• Working knowledge of FDA regulations, ICH guidelines, GCP, SDTM, CDISC, database development
• Oncology experience and/or working knowledge of Oncology
• Experience leading infrastructure assessment and improvement

ORGANIZATIONAL RELATIONSHIPS

• Clinical Diagnostics and Translational Science Operations (CDx-TSO) within Clinical Pharmacology and Translational science (CPTS) part of Pfizer Oncology Division.
• Matrix relationships particularly with Translational Oncology, Clinicians, Global Clinical Trials Execution, Clinical Operations, Development China, and external collaborators, as appropriate.

RESOURCES MANAGED

• May act in Supervisory role for Clinical Biomarker Specimen Specialists or other Clinical Biomarker Operations team members

PHYSICAL/MENTAL REQUIREMENTS

Sitting

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Periodic travel may be required

The annual base salary for this position ranges from $102,900.00 to $171,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a