Careers

Director/Senior Director, Clinical Operations

Job Description

The Director/Sr. Director of Clinical Operations will help drive the company’s development strategies and implementation of the company’s clinical studies and development programs. In this position, the ideal candidate will be responsible for the day-to-day management of Phase 1 to 3 stage clinical programs, be instrumental in ensuring clinical programs are developed, managed and executed with the highest integrity of clinical site protocol and site execution; ensuring compliance to clinical practices and protocol so that clinical results are obtained and program objectives are delivered on time and within budget. In this role, the ideal candidate will be responsible for the program management of one or more clinical trials and may act as program team leader or member while also serving as a resource to the clinical department and the company to achieve our clinical research objectives. The position will report to VP, Clinical Development.

Responsibilities

  • Leads CRO selection process for assigned clinical programs
  • Manage day-to-day clinical operations activities and implementation of clinical studies and development programs
  • Management of CRO’s and clinical team members in clinical study development, clinical trial site training and initiation, program timelines, budget and resource allocation
  • Maintains effective relationships with clinical collaborators, clinical sites, clinical team members, clinical management team, and provides weekly updates and documentation of team meeting minutes, patient enrollment data, clinical program status and alerts. Provides general trouble-shooting and problem solving to ensure the best possible outcome of the clinical research program
  • Attends or leads cross-departmental project team meetings, including preparation of meeting agenda, project team leadership, and timely and accurate publishing of project team meetings decision and action items
  • Develops and manages cross-functional program operation plans, cost estimates, budget management and communicates with senior management with status, alerts, and clinical program milestones as they fit into overall corporate objectives
  • Prepares and distributes clinical program status reports on a weekly basis to the project team and senior management to ensure that timely deliverables of the program objectives, address any issues or updates, and ensure that company clinical objectives are being met or exceeded

Qualifications/Requirements

  • BS/MS in a scientific field or equivalent; RN degree would be a plus. Apexigen is developing sophisticated biologic therapeutics in technically challenging therapeutic areas, so ability to understand and communicate to this level of sophistication is required
  • 10+ years of clinical research management hands-on experience is required (experience in a small biotech/ resource constrained environment is desirable)
  • Prior experience as a site monitor is a plus and 5+ years directly managing multicenter trials is a requirement
  • Experience directly managing multinational trials is strongly preferred, with fluency in both FDA and EMEA regulatory requirements
  • Experience with complex Phase 1 and Phase 2 clinical trials is most important, particularly with biologic agents and trials with multiple pharmacokinetic and pharmacodynamic endpoints. This experience is important as these types of trials require more complex coordination, especially with regards to site training, sample acquisition and shipping
  • Excellent analytical skills, negotiation skills and problem solving skills
  • Outstanding written, interpersonal, presentation, communication and training skills
  • Strong influencing skills are required to manage clinical sites, coordinate with clinical investigators, with the ability to be proactive and agile to adjust and communicate changes in clinical project issues
  • Must be candid and transparent when reporting status and alerts to the clinical team, clinical management and senior management of the company in a full-disclosure and proactive manner
  • Candidates must be experienced with a proven track record in a clinical research management, high-energy, able to function in a growing, dynamic environment and able to multi-task and communicate at all levels within the organization


All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

To Apply

Email resumes to career@apexigen.com. Please reference Job ID: Director/Senior Director, Clinical Operations

Apexigen is an equal opportunity employer