Careers at OncoMed
OncoMed, a pioneer and leader in the development of novel cancer therapies directed toward tumor initiating cells, also known as “cancer stem cells”, fosters a culture of innovation as the company strives to provide significant alternatives for the treatment of cancer.
Headquartered in Redwood City, California, our employees bring a passionate dedication to the advancement of novel treatments for patients with cancer.
Director of Clinical Operations
Responsible for the planning, implementation and conduct of global clinical trials in a fast paced oncology focused company.
Provide operational leadership and ensure the successful implementation of multiple global Phase 2 clinical development programs.
Drive the planning of study program timelines and budgets to ensure internal and external program milestones are met.
Accountable for the quality of the data and work product for all outsourced services including: clinical operations, data
management, biostatistics, regulatory and pharmacovigilance.
- Candidate must have a min. BS/BA degree and at least eight to ten (8 - 10) years clinical operations/development experience
- Recent experience with outsourcing and launching global oncology studies is a requirement for this position. Responsible for all clinical operations activities for multiple early phase studies specifically focused on the execution of clinical studies based upon corporate goals and objectives. Oversee the tactical implementation of the clinical development plan for all assigned clinical programs by managing the site contracts, budget, timelines, CRO resources, enrollment, and site activities.
- Develop and execute a proactive strategy to ensure that all assigned clinical study operations activities are conducted efficiently, meet enrollment goals, and are in compliance with all applicable regulations and corporate policies and procedures
- Oversee the data collection activities for all assigned clinical programs. Provide input on CRF design and ensure quality data is monitored and available to support annual reports, investigator brochures, regulatory filings, and safety summaries
- Participate in the evaluation, selection and management of CROs, contractors, and vendors. Manage overall clinical trial budget and timelines for all assigned clinical programs. Develop and maintain effective working relationships with internal team and external partners
- Identify issues that may impact the overall project plans and initiate contingency plans, as appropriate. Provide positive, professional leadership as a Clinical Operations representative for OncoMed Pharmaceuticals
- Proven knowledge of the drug development process, Good Clinical Practices and FDA regulatory requirements
- Ability to lead and drive program planning and delivery in collaboration with CRO partners
- Proven problem-solving skills to prevent and overcome complex safety and compliance related issues during clinical program implementation and execution
- Willingness to take on a wide range of responsibilities with limited resources
- Highly organized and able to prioritize and handle multiple tasks simultaneously
- Experience with conducting early Phase oncology clinical trials
- Experience with management of multiple services for multinational clinical trials
- CRA site monitoring and CRO management experience
- Experience with clinical database build and eCRF design
- Ability to independently solve problems related to CRO and site management activities
- Reports to Sr. Director, Clinical Operations