Director, Clinical Operations

Position Summary

The Director, Clinical Operations will build and lead a diverse and dynamic Study Team

responsible for planning and coordinating the conduct of clinical trials, including protocol

development, site and vendor assessment, and ensuring adherence to GCP and other

applicable guidelines and regulations. In addition, the Director, Clinical Operations will partner

with cross-functional stakeholders in Clinical Development and other functions to develop

systems and procedures to assure uniform operation of all projects in the department. This

position is accountable for Clinical Operations deliverables and for updating management on the

status of responsible programs.

Responsibilities:

• Provide oversight and leadership to cross-functional Study Team(s)
• Develop the strategies and tactics to ensure the team is high functioning and executes
  
  

according to timelines, budgets, and corporate objectives

• Plan resources and tasks to meet corporate goals for timely initiation and completion of
  
  

clinical studies

• Recruitment and mentorship of development operations personnel in US and China
• Be an active member of Clinical Development Teams to provide direction and oversight
  
  

to Study Teams

• Manage overall study activities, including vendor selection, investigator recruitment and
  
  

selection, study start-up, enrollment, data collection, study close out, and reports

• Accountable for CRO selection, development of RFPs, budget negotiations, and overall
  
  

CRO management

• Manage team members responsible for CRO and vendor oversight.
• Develop and review SOPs and guidelines for compliance with global regulatory
  
  

requirements, including establishing appropriate processes and procedures to conduct

global clinical trials

• Oversight of clinical vendor and site budgets and contract negotiation
• Contribute to the development of study plans, study reports, sections for Investigator's
  
  

Brochures, and regulatory documents (e.g., IND, NDA or BLA)

• Interact with investigators and thought leaders for SAB meetings, development of patient
  
  

engagement plans, and study execution

• Participate in investigator meetings
• Coordinate clinical site audit activities including pre-inspection training at clinical sites in
  
  

partnership with QA

• Establish systems for tracking of various activities during clinical trials, e.g.,
  
  

accruals/invoices, tracking of clinical reviews, data query resolution, etc.

• Oversight of Trial Master Files according to applicable domestic and/or international
  
  

regulations and internal SOPs

• Participate in monitoring visits, including Site Qualification, Site Initiation, and Close Out
  
  

as needed

• Able to travel internationally to meet with team members as needed to build
  
  

collaboration across development operations

Education and Experience Required:

• BS and/or graduate degree in a technical discipline with a minimum of 12 plus years of
  
  

pharmaceutical and biotechnology industry experience running multinational clinical trials

• Proven track record of successfully managing staff and CROs for a minimum of 5 years
• Knowledge of and competence in application of GCPs, ICH guidelines, and clinical drug
  
  

development

• Highly motivated, results driven individual with excellent organizational, interpersonal and
  
  

communication skills and experience working in geographically distributed teams and

interacting with all levels of the organization

Knowledge, Skills and Abilities:

• Proven success in leading and coordinating global, cross-functional clinical operations
  
  

teams

• Proven ability to build strong relationships with global CROs/vendors and to manage
  
  

CROs and vendors throughout entire clinical operations life cycle

• Excellent interpersonal skills, strong written and verbal communication/presentation
  
  

skills necessary to meet the needs of various audiences

• Strong team leadership experience and motivational skills
• Able to problem solve and use good judgement
• Detail oriented
• Strong program management skills
• Strong people management skills
  
  

Travel:

• Up to 25 %
  
  

The target salary range for this full-time role is $218,000 - $262,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.