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Senior Director, Clinical Operations

  • Location: San Mateo County
  • Job Type:Permanent

Posted 17 days ago

  • Sector: Pharmaceutical, Biotech, Clinical
  • Contact: Stefanni LaJeunesse
  • Contact Email: s.lajeunesse@sciproglobal.com
  • Contact Phone: 310-773-0258
  • Expiry Date: 19 May 2021

SciPro has teamed up with a premier biopharmaceutical client that focuses on the discovery, development, and commercialization of novel therapeutics to treat autoimmune diseases, inflammatory disorders, and cancer to add a Senior Director, Clinical Operations. In this role you will head, direct, manage and develop a team of operational professionals and be responsible for developing and implementing the clinical operational strategy.

Responsibilities for Senior Director, Clinical Operations:

Clinical Operations Responsibilities:

·       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

·       Coordinate or plan investigator meetings and/or site and CRA training with CTMs

·       Ensure adequate clinical-operational resource allocation across studies and programs

·       Review and QC central clinical files and Trial Master File in collaboration with the Quality group

·       Oversee, review, maintain, and implement departmental SOPs and processes to ensure compliance

·       Oversee activities to prepare for internal GCP audits and regulatory GCP inspections in close collaboration with the Quality group

·       Ensure compliance with all ICH/GCP requirements, organizational SOPs and organizational requirements

·       Track key performance indicators and identify gaps and inefficiencies of clinical-operational processes

·       Ensure successful execution, best practices as well as consistency of the clinical program trials/programs to meet clinical organizational goals

·       Represents Clinical Operations internally to Sr. Management as the primary point of contact and on cross-functional project teams

CRO/Vendor Responsibilities:

·       Collaborate with CTMs and Finance department, in oversight of budgets, timelines, vendor proposal and bidding development (RFP creation and analysis), the development and review of service agreements, approval of vendor payments and expenditures against contract and budget plan

·       Represent Clinical Operations externally to operational business partners, vendors, CROs, Investigators and trial site administrators

·       May travel to CRO/vendor facilities and/or investigator sites to assess or train personnel and processes where applicable

 

Education/Background Requirements for Senior Director, Clinical Operations:

·       Advanced degree preferred or Bachelor's in a biological science-based subject.

·       At least 10 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

·       Strong business acumen, clear communicator and confidence in presentation and communication to senior management

Position Requirements for Senior Director, Clinical Operations:

·       Experience in clinical-operational aspects of drug development of all phases

·       Experience authoring or reviewing clinical study protocols, investigator brochures, and clinical study reports

·       Experience exercising compliance with ICH GCP guidelines and organizational SOPs to ensure the appropriate conduct of clinical studies in the US, Europe, and internationally

·       Experience devising accurate cost-effective but realistic budget plans, resourcing plans and timelines

·       Demonstrates ability to make critical decisions related to clinical vendor contract negotiations

·       Proven track record of successful trial execution, site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc

·       Cross Collaboration proficiency with other functions such as Research, Drug Supply, Project Management, Quality, Data Management, Regulatory and Finance

·       Travel up to 15-20% may be required