The Clinical Operations Associate Director combines end-to-end design, execution, and reporting of oncology clinical trials with leadership in study teams and across matrix teams. This position is accountable for planning and leading the delivery of studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protocol.
Requirements
- Accountable for the global study delivery strategy
- Guide assessment, selection, engagement, management, and oversight of appropriate vendors
- Assure consent with ICH/GCP guidelines, all applicable laws and regulations, and Exelixis SOPs
- Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project
- Collaborate with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation
- Responsible for the preparation of materials for internal governance and / or financial review cycles
- Actively partner to build relationships and collaborate with aligned staff in other functions
- Encourage others within matrix and line teams to seek alternative perspectives and develop solutions
- Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary
- Identify and communicate resource gaps for assigned studies
- Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
- Lead/contribute to ways of working and process improvement initiatives
- Provide expert clinical operational input into protocol development
- Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study
- As the SDL, lead the SDT and actively partner to build relationships and collaborate with SDT
- Work with the appropriate functions to develop patient centric documents and address patient burden
- Contribute to and engage Clinical Operations staff in process development, innovative problem solving, training initiatives as needed
- Provide proactive and consistent oversight of CRO and vendor performance
- Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Long-term incentives
- 17 paid holidays including a company-wide winter shutdown in December
- 10 sick days throughout the calendar year
