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Associate Director/Director, Clinical Operations Excellence

Employer
AnaptysBio, Inc.
Location
San Diego, CA
Start date
Nov 16, 2022

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Job Details

Job Type Full-time

Position Summary:

The Associate Director/Director of Clinical Operations Excellence is a key member of the Clinical Operations organization and will be accountable for implementing a continuous improvement culture within clinical trials in support of Clinical Operations. The Associate Director/Director of Clinical Operations Excellence will also be a key driver of identifying process gaps, proposing potential solutions, and implementing these in a harmonized way to help realize AnaptysBio’s long-term strategy and goals. This individual will develop, plan, and execute on process improvement and operational initiatives related to clinical trials and ensure integration with systems using a risk-based management approach in collaboration with QA. This role will also work collaboratively and strategically with the Clinical Operations department, cross-functional teams and external partners to establish standards for TMF-related activities including: implementation of a global eTMF system, TMF-related SOPs, processes and best practices; development of metrics and tracking of eTMF performance to ensure and promote a continuous state of inspection readiness, and compliance with regulatory requirements and the principles and GCP and GDPR standards. 

Job Responsibilities:

  • Plan, develop, execute, and track process improvement and operational initiatives related to clinical trials and ensure integration with systems using a risk-based management approach in collaboration with Quality Assurance department
  • Ensure adherence to regulatory requirements (FDA, EMA, etc.) and ICH GCP guidelines through the establishment and reporting of clinical key performance indicators (KPIs) as well as through the use of innovative and agile methodology to improve processes
  • Lead the development/revision of relevant quality documents (SOPs, templates) and processes
  • Maintain a proactive GCP compliance management infrastructure/process, including clinical trial oversight processes, monitoring and quality control of key processes (i.e., eTMF management), standard operating procedures, process improvement, and training recommendations
  • Accountable for the leadership of the TMF organization, inclusive of TMF technology & systems, TMF operations, TMF inspection readiness and TMF outsourcing & vendor governance and establishment of KPIs for TMF health tracking
  • As the TMF process leader and SME, establish processes that ensure project documentation is maintained to the highest level of quality and compliance with ICH GCP guidelines and country regulations
  • Manage the TMF vendor and oversee maintenance of the TMF records management system including secure storage, retrieval, retention, archival and destruction per AnaptysBio SOPs
  • Provides support to clinical teams during regulatory filings and potential HA inspections for document organization and retrieval, as applicable
  • Participate in independent audits of vendor (CRO) TMFs, internal TMF audits, archive document systems and facilities, as applicable
  • When required, this role may also provide strategic and technical guidance to ensure clinical trials are properly defined, planned and executed.

Supervisory Responsibilities:

  • Hire, train and develop Clinical Trial Assistants and Operations Excellence staff, as required 
Requirements

Education and Experience:

  • 6+ years experience in clinical trial management (minimum 2 years of direct TMF oversight experience)
  • Experience managing and overseeing vendors is required 
  • Experience managing staff and resources to meet changing timelines is preferred
  • Knowledge of TMF best practices, TMF regulatory agency expectations, GCP and other regulations
  • Understanding of drug development and program management from pre-IND through regulatory filing is highly desired
  • Demonstrated excellence in complex project management and effective management of multiple projects/priorities
  • Previous involvement in the oversight and management of GCP regulatory inspections preferred

Knowledge and Competencies:

  • Leverages prior experience with external benchmarking, industry best practices, and technology for continuous improvement.
  • Ability to solve problems with innovative solutions along with strong organizational skills. 
  • Demonstrated analytical ability, with attention to detail, and systems aptitude
  • Ability to organize/analyze multiple data sources into a cohesive result through the utilization of various analytical tools and technologies
  • Cross-functional leadership skills to collaborate with all levels within the organization and to influence across multiple functions and geographies.
  • Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well.
  • Self-motivated, independent, and results-oriented 
  • Excellent written and verbal communication skills are required.

Company

AnaptysBio is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. We are developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, our PD-1 agonist program in a Phase 2 trial for the treatment of moderate-to-severe rheumatoid arthritis; and ANB032, our BTLA agonist program, currently in a Phase 2b trial for the treatment of moderate-to-severe atopic dermatitis. Our preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody for the treatment of autoimmune and inflammatory diseases. In addition, AnaptysBio has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. AnaptysBio has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immune-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).

Our corporate vision is to transform patient health by delivering innovative immunology therapeutics. Find out more about us by following us on Twitter.

 

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Company info
Website
Phone
858-362-6295
Location
10770 Wateridge Circle
Suite 210
San Diego
California
92121
United States

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