Director – Clinical Study Support
| Company | Exelixis |
|---|---|
| Location | Alameda, CA, USA |
| Salary | $208000 – $295500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- BS/BA degree in related discipline and a minimum of 13 years of related experience; or,
- MS/MA degree in related discipline and a minimum of 11 years of related experience; or,
- PhD in related discipline and a minimum of 8 years of related experience; or,
- Equivalent combination of education and experience.
- Typically requires a minimum of 5-8 years of significant experience in managing clinical operations with strong knowledge of ICH/GCP and Regulatory requirements driving clinical development.
- Experience in Project Management (PMP a plus), Process Improvement, People Management, Change Management, Stakeholder Management, and management of resources from different sources in different locations (internal, external, and functional service providers).
- Experience in the Biotech/Pharmaceutical industry.
- Management experience including outsourcing to Contract Research Organizations.
Responsibilities
- Manage and lead a team of CTMs; SCTSs; and CTSs with the structure of the Clinical Operations team.
- Ensure appropriate level of qualified and trained resources to support study delivery and the delivery of Human Subject Research studies within the deadlines, budgets, and quality, according to ICH/GCP, company control documents, and regulatory requirements.
- Responsible for quality practices, management monitoring, control documents development, and training related to the CTM, SCTS, and CTS roles.
- Responsible for setting and implementing management monitoring of CTM, SCTS, and CTS roles-related processes.
- Accountable for a high level of Quality Control (QC) is embedded in the CTM, SCTS, and CTS day-to-day activities.
- Manage harmonization of proactive at task/activity/process level for CTM, SCTS, and CTS, to ensure consistency, high quality, and efficiency.
- Lead department-wide continuous improvement and capability-building efforts to maximize operational efficiency, effective decision-making, streamline study execution, and enhance cross-functional collaboration.
- Drive the implementation of new practices and best practice sharing.
- Define and analyze resource requirements as per study projections and business needs in collaboration with SDLs, Indication Leads, and/or Clinical Operations Program Leads.
- Support VP of Clinical Operations with budgets associated with CTM, SCTS, and CTS headcount.
- Drive innovative approaches to study delivery through external facing advances in technology and science.
Preferred Qualifications
- Proven clinical development experience across all phases of development (I-IV).
- Proven expertise in driving optimization, process improvement, and capability-building efforts.
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict.
- Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
- Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks to deliver value.