Manager/Senior Manager, Clinical Operations

Location
South San Francisco, CA
Salary
TBD
Posted
Jul 12, 2021
Required Education
Bachelors Degree
Position Type
Full time

About Surrozen

Surrozen is a biotechnology company focused on discovering and developing novel regenerative medicines with a focus on unlocking the powerful self-renewal properties of the body through specific control of the Wnt signaling pathway.

Surrozen was founded by five leading-edge scientists: K. Christopher Garcia, Ph.D., Roel Nusse, Ph.D. and Calvin Kuo, M.D., Ph.D. from Stanford University; Claudia Janda, Ph.D. from the Princess Maxima Center for Pediatric Oncology; and Hans Clevers, M.D, Ph.D. from the Hubrecht Institute and Princess Maxima Center in the Netherlands. Each has conducted extensive research on Wnt signaling, with findings that together shape Surrozen’s technology and approach to therapeutic development.

Position Summary

The Manager/Senior Manager of Clinical Operations will provide clinical operations expertise and leadership supporting conduct and oversight of one or more clinical studies in accordance with applicable quality standards including Surrozen SOPs, ICH/GCP, and applicable regulations, rules and guidance. The Manager/Senior Manager will work under the direction of the Director of Clinical Operations responsible for the relevant products under study, coordinating activities across department functions supporting clinical study execution.

Responsibilities

  • Initiate, manage, and oversee the operational execution of Clinical Studies, with primary accountability for clinical study monitoring and related quality and compliance oversight
  • Lead at least one clinical operation team for one or more products, and coordinate with other participating functional departments/stakeholders ensuring collaborative work effort and transparent communication
  • Proactively identify, manage, and escalate project risks and related issues
  • Oversee budgets and development of staffing/resourcing plans, including forecasting and accrual management
  • Track and report on operational clinical study deliverables in collaboration with Project Management
  • Facilitate selection, manage and maintain quality oversight of third-party vendors managed by clinical operations, both study specific and cross program vendors, including Clinical Study sites
  • Participate in selection of any other vendors supporting Clinical Study execution
  • Develop operational Clinical Study specific plans and contribute to development and review of other clinical and regulatory plans and documents (e.g. clinical protocols, regulatory submission and response documents, statistical analysis plan, clinical study reports, etc.)
  • Coordinate and track completion of applicable Clinical Study specific training by participating personnel within Surrozen and across applicable vendors
  • Manage Clinical Study documentation, including primary management of the Trial Master File
  • Line manage other clinical operations personnel and/or manage external contractors supporting operations, as applicable
  • Participate in continuous quality and process improvement activities for the clinical operations function, and identify areas of best practice and process improvements
  • Lead and participate in department specific and company wide initiatives and programs as assigned, including but not limited to development of SOPs, cross project initiatives, training, etc.
  • Maintain awareness and training on current applicable regulations, rules, guidance

Requirements

  • Bachelor’s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study
  • Minimum of 7 years of experience in a CRO and/or pharmaceutical/biotechnology company, including a minimum of 2-4 years of direct clinical study management, including direct responsibility of external vendor management. Some experience in Phase 1 or investigator-initiated studies preferred. Equivalent experience in other setting (e.g. academic) will be considered; clinical site monitoring experience preferred
  • Experience leading clinical operations team and cross functional team management. Global trial experience preferred
  • Line management experience or experience demonstrating knowledge of applicable skillset preferred
  • Experience establishing and maintaining positive and effective relationships with CROs and other clinical vendors, including negotiating and establishing methods of collaborative oversight (e.g. establishing Key Performance Indicators), and budget management
  • Knowledge and/or experience in managing vendor selection process, including developing requests for information/proposals, and proposal content/budget analysis
  • Solid knowledge of operational management of a clinical study including the development of timelines, budgets and resource plans
  • Experience in leading and contributing to development of technical documents, such as protocols, protocol amendments, informed consent, or other study-related documents
  • Strong knowledge of Good Clinical Practices (as defined by ICH) and experience working under/knowledge of US Code of Federal Regulations applicable to the conduct of clinical trials (e.g., 21 CFR Parts 11, 50, 54, 56, 312 and 314), with some knowledge of international trial regulations (e.g. EU Clinical Trial Directive and predecessors) preferred
  • Knowledge of financial reporting requirements of a public organization, including physician payment transparency, concepts of Fair Market Value Proficiency with computer programs including Microsoft Office suite and Microsoft Project
  • Able and willing to travel up to 25% including domestic and international travel
  • Well-developed written and verbal communication skills
  • Strong attention to detail and dedication to accurate and high-quality work
  • Focus on results, highly collaborative cross functionally, positive attitude, and being proactive
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Creative problem solver with the ability to address issues quickly and independently, balanced with judgement to escalate issues as needed

Benefits

  • We offer a dynamic startup environment and a collaborative, passionate team
  • Excellent benefits, including competitive employer contributions
  • Stock options
  • Paid vacation, sick time and holidays
  • Shuttle service to/from Caltrain, BART and SSF Ferry
  • State-of-the-art facility complete with bowling alley and onsite gym (see the amenities available at The Cove)