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Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals Inc., is developing and marketing NexavarŽ (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing.
Summary
The Manager, Clinical Operations will manage the activities and personnel associated with the evaluation, initiation, management, and close-out of clinical trials within the Clinical Development department. This position will also work with the Clinical Operations team in the development and management of a Clinical Trials Management System (CTMS) and identifying clinical infrastructure gaps and develop systems/processes for addressing the gaps. The Manager role provides an outstanding opportunity to work in a matrix environment and collaborate with colleagues in clinical data management, biostatistics, regulatory, safety, and project management.
Responsibilities
Clinical Trials Management System (CTMS)
Manage CTMS vendor relations
Install and validate 21CFR Part 11 compliant CTMS
Manage day-to-day use of CTMS
Prepare and implement training procedures for CTMS application
Monitor field use of CTMS and recommend and implement improvements
Clinical Study Management
Identify, select, and monitor investigational sites for clinical studies
Manage team of Clinical Operations personnel including CRAs and Clinical Assistants
Ensure studies are carried out according to study protocol, SOPs, and ICH/GCP regulations
Track progress of study including patient enrollment, monitoring visits
Prepare and monitor study metrics against agreed upon targets
Investigate queries, monitor discrepancies
Manage the site conduct, and the investigational product accountability and reconciliation process
Manage the budget and payments for investigative sites and contract organizations
Write or contribute to preparation of clinical protocols, amendments, consent forms, study guides, CRFs, and any other clinical research related document
Develop queries for data analysis
Negotiate and finalize investigator budgets
Review data listings and summary tables, including query generation
Oversee performance of CROs and contract CRAs to ensure compliance with study protocol
Co-monitor sites with CRAs
Train CRAs on protocols and practices consistent with Onyx and GCP standards
Assist in identification and hiring of appropriate CROs and study vendors
Generate and/or review relevant sections of clinical study reports, IND annual reports, and Investigator Brochures
Departmental Infrastructure
Collaborate with CRAs and Directors to identify Clinical Operations process needs
Identify/develop processes and procedures for enhancing department efficiency
Develop plans for implementation of departmental infrastructure enhancements
Conduct SOP gap analysis and oversee preparation of new or modified Clinical Operations SOPs
Requirements
Bachelor's degree in a scientific discipline or equivalent
Minimum 5 years directly related experience overseeing multiple concurrent trials
Experience with managing Clinical Operations personnel
Experience with Clinical Trial Management Systems
Thorough knowledge of GCP/ICH guidelines including an understanding of regulatory requirements
Thorough knowledge of clinical study management
Must be well versed in FDA regulations and GCP
Ability to work independently and exercise good judgment in planning and accomplishing goals
Strong oral and written communication skills, along with good organizational and planning skills are a must
Ability to deal with time demands, incomplete information or unexpected events and work effectively in a team/matrix environment
Advanced computer skills, experience with administration of site budgets and grants with supervision and experience with reviewing adequacy of site-proposed informed consents for compliance with relevant regulations
Oncology experience preferable
Requires up to 25% travel
Contact
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The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters.