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Senior Clinical Program Manager or Clinical Program Manager Oncology

Reference Number: 2794
Location: CA

Our client is a global, research-based biopharmaceutical company.  They have asked us to assist them in their search for a Senior Clinical Program Manager or Clinical Program Manager – Oncology.

Major tasks and responsibilities will include:

  • Responsible for the overall operational execution of clinical studies on one or more clinical projects/programs; from study concept through study completion (i.e., Clinical Study Report - CSR finalization).
  • Has direct reports and manages study team across a matrix with assigned clinical operations and cross-functional study team members to ensure compliance and execution of deliverables within approve budget and timelines.
  • Is aware of both internal and external business environments, assess impact on clinical studies and make modification as necessary.
  • Escalates performance issues to management with risk evaluation and mitigation plan(s) for resolution and ensures coordination/sharing of information within Development Operations.
  • Manages the implementation, on-time execution and conduct of clinical studies; including the development of the Study Plan which includes key milestones, timelines; study costs, vendor selection and resource needs as well as ensuring quality and compliance.
  • Provides input on regulatory documents (e.g., Investigator’s Brochure (IB), CSR, Investigational New Drug (IND/IMPD), New Drug Application (NDA), Biologic License Application (BLA), Marketing Authorization Application (MAA),  Annual Report and Development Safety Update Report (DSUR).
  • Effectively communicates study progress and actively identifies issues that potentially impact evaluable study data, ethical study conduct, Code of Federal Regulations or other local regulations/guidelines and International Conference on Harmonization/Good Clinical Practice (ICH-GCP) compliance and identifies in Risk Evaluation/Mitigation format potential interventions or solutions to manage the issues.
  • Develops and approves investigative site 'per patient' budget parameters and negotiates clinical study agreements along with budgets/contracts for third party vendors.

We seek candidates with the following qualifications:

  • For Senior Clinical Program Manager:
  • Bachelor’s Degree or equivalent is required, typically in nursing, medical or scientific field.  An Associate’s degree/R.N. or equivalent with relevant experience is acceptable.
  • 7+ years of pharmaceutical or biotech-related/clinical research-related experience.
  • Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
  • Possesses good communication skills and demonstrated leadership abilities.
  • Demonstration of successful coaching/mentoring in a matrix environment.
  • Considered a subject matter expert and competent in application of standard business procedures (SOPs, ICH-GCP, Global Regulations, Ethics and Compliance).
  • Experience in successful study initiation through study completion/primary data analysis and/or in multiple phases of clinical development (Phase I-3, 4).
  • Direct people management experience is preferred.
  • For Clinical Program Manager:
  • Bachelor’s Degree or equivalent is required, typically in nursing, medical or scientific field.   An Associate’s degree/R.N. or equivalent with relevant experience is acceptable.
  • 6+ years of pharmaceutical or biotech-related/clinical research related-experience.
  • Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
  • Possesses good communication skills and demonstrated leadership abilities.
  • Demonstration of successful coaching/mentoring in a matrix environment.
  • Competent in application of standard business procedures (SOPs, ICH-GCP, Global Regulations, Ethics and Compliance).
  • Exposure with study initiation through study completion in multiple phases of clinical development (Phase 1-3, 4) is preferred.
  • Key Leadership Competencies:
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Learns fast, grasps the 'essence' and can change the course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, opens to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2794. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.