Associate Director Clinical Operations - Rapidly Growing, Oncology Focused Biotech - South SF
Job Summary Our client is an expanding, commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. The Associate Director, Clinical Operations is responsible for the development and implementation of strategic direction in the conduct of multiple clinical studies. You will provide oversight to the clinical programs whilst acting as a senior figure in the Department and representing Clinical Operations in cross-functional meetings and initiatives. This is a managerial role and will have direct line management at CTM and CRA level.
Job Overview • Accountable for overall management of multiple clinical trials:
- providing strategic direction to study teams to meet corporate study goals and timelines;
- oversight of vendor budgets and contracts,
- reporting and justification of study metrics
• Participates in the selection of Contract Research Organizations (CROs)
• Attend CRO and other vendor meetings such as project kick-off and investigator meetings
• Provides consistent, regular oversight of CRO and vendor performance
• In partnership with Clinical Operations senior management contributes to definition, development and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices
• Contributing member of various study and program teams such as the Study Management team (SMT); provides direction to lead CTMs in creating meeting agendas and documenting outcomes and deliverables
• Contributes to the development of staffing/resourcing plans
• May act as designee for Vice President, Clinical Operations, as appropriate
• Contributes to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed
• Travel may be required up to 20% in support of clinical study activities
• Directly supervises employee(s). Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors
Skills Required Education:
• BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience
• May require certification in assigned area.
• Typically requires a minimum of 8-10 years of related experience or a minimum of 12 years combined education/training and experience.
• Experience in Biotech/Pharmaceutical industry preferred.
• Management experience including outsourcing
Contact Details To discuss this opportunity further please contact Sean Farrell at 628-225-1200 or by email at firstname.lastname@example.org
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