Senior Director, Clinical Operations
Clinical | San Carlos, CA | Full Time
ChemoCentryx is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
As a clinical-stage company with a broad portfolio in multiple therapeutic areas, ChemoCentryx pushes beyond “good enough” and strives for a totally new way of healing.
Reporting to the Vice President of Clinical Development and Translational Medicine at ChemoCentryx the Senior Director of Clinical Operations with 10+ years of solid clinical-operational trial experience in multiple leadership positions will head, direct, manage and develop a team of operational professionals and be responsible for developing & implementing the clinical operational strategy. A core responsibility is to direct clinical operations activities and drive decisions. Successful oversight of quality in accordance with applicable regulations, ICH/GCP guidelines and Standard Operating Procedures (SOPs), budgets and expenditures, timelines, resourcing are key. Staff oversight, development, recruitment, and retention is equally important. The individual will have solid business acumen, is a clear communicator and will work independently and efficiently in a dynamic, fast-pace work environment of a rapidly growing organization, hereby delivering the highest standard of a quality work product.
- Ensures successful execution, best practices as well as consistency of the clinical program trials/programs to meet clinical organizational goals.
- Track key performance indicators and identify gaps and inefficiencies of clinical-operational processes.
- Ensures compliance with all ICH/GCP requirements, organizational SOPs and organizational requirements.
- Oversee, review, maintain, and implement departmental SOPs and processes to ensure compliance
- Review and QC of central clinical files and Trial Master File in collaboration with the Quality group.
- Oversee activities to prepare for internal GCP audits and regulatory GCP inspections in close collaboration with the Quality group
- Ensures adequate clinical-operational resource allocation across studies and programs
- Build, manage and direct team of CTM/CRAs and other resources within Clinical Operations
- Review, contribute, or oversee CTMs in the completion of study protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents.
- Coordinates or plans investigator meetings and/or site and CRA training with CTMs.
- Oversees process of CRO/vendor selection and management and vendor budget management.
- Oversees the development and review of service agreements, budgets, and timelines, and ensure that performance expectations are met.
- Oversees CTMs in vendor proposal and bidding development (RFP creation and analysis) including vendor bid defense meetings. Demonstrates ability to make critical decisions related to clinical vendor contract negotiations.
- Development of risk management plans and development of strategies to mitigate risk
- In collaboration with Clinical trial managers and Finance department, oversees approval vendor payments and expenditures against contract and budget plan.
- May travel to CRO/vendor facilities and/or investigator sites to assess or train personnel and processes where applicable.
- Represents Clinical Operations
- internally to Sr. Management as the primary point of contact and on cross-functional project teams
- externally to operational business partners, vendors, CROs, Investigators and trial site administrators for clinical-operational aspects
- Advanced degree preferred or Bachelor's in a biological science-based subject.
- At least ten years of global trial and clinical operational management experience in a clinical research environment in leadership positions, most of which should be in established pharmaceutical or similar industry organizations
- Solid experience in clinical-operational aspects of drug development of all phases and proven track record of success,
- Multi-dimensional clinical operations background with capability of devising accurate cost-effective but realistic budget plans, resourcing plans and timelines
- Track record of successful trial execution, site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
- Track record of effective vendor oversight to meet expected quality and timelines and to stay within budget
- Familiarity with Electronic Data Capture (EDC) and data management requirements
- Track record of exercising compliance with ICH GCP guidelines and organizational SOPs to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
- Prior participation in a leading role in pre-approval regulatory inspections is a definitive plus.
- Solid Business acumen, clear communicator and confidence in presentation or communication to senior management
- Outstanding verbal and written communication skills including experience including in authoring or reviewing clinical study protocols, investigator brochures, and clinical study reports
- Excellent people management skills and organizational experience
- Cross Collaboration proficiency with other functions such as Research, Drug Supply, Project Management, Quality, Data Management, Regulatory and Finance.
- Creative, capable problem-solver
- Travel up to 15-20% may be required