Clinical Trials Operations Manager

Position Title: Clinical Trials Operations Manager

Allakos is a clinical-stage company developing therapeutic antibodies that selectively target immunomodulatory receptors present on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases.

Position Summary:

This position manages various logistical and operational aspects of the clinical development program. Collaborates with TechOps on drug demand forecasts and supply timelines to ensure clinical site drug availability. Coordinates and facilitates the procurement of medical equipment and supplies for clinical sites participating in Allakos studies. Coordinates data hand back to clinical sites.

This position requires a proven track record of increasing responsibility in clinical operations or clinical supply.

Experience with large, complex late-stage global clinical development programs required. BLA/NDA filing and experience in a related field highly desired.

Responsibilities:

Clinical Supply

• Processes Temperature Excursions reported by clinical sites
• Reviews site temperature logs to identify unreported temperature excursions
• Collaborates with TechOps to generate drug demand forecasts
• Provides enrollment data and study timelines to TechOps to ensure drug availability
• Collaborates with TechOps and QA to perform final study drug reconciliation
• Reviews and approves clinical site drug destruction procedures

Interactive Response Technology (IRT)

• Works with IRT vendor and Allakos study PM's to develop system requirements
• Manages system development timelines in line with study startup
• Manages User Acceptance Testing
• Initiates change orders and system updates as needed
• Processes IRT data change requests
• Reports on discrepancies between IRT and Electronic Data Capture (EDC) systems
• Generates weekly enrollment dashboards

Other Supplies

• Places and tracks orders for equipment loans and non-IP study supplies for clinical sites
• Generates purchase orders for equipment and ancillary supplies
• Manages equipment return

General

• Review protocols and advise on the operational feasibility and logistics involved in the execution and conduct
• Coordinates end of study data hand-back to clinical sites.
• Participates in corporate committees, task forces, technical or business meetings as requested.
• Ensure timely and appropriate response to clinical investigator site issues or other study management problems.
• Prepare communication and status reports to provide updates/information to executive management.
• Demonstrate mastery of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
• Represents Allakos in a professional manner; establish and maintain superior relationships with Investigators, advisors, other study personnel, clients and vendors.
• Attends seminars, Investigator meetings, project team meetings, educational conferences/training sessions, etc.

Qualifications:

• Bachelor's Degree required. Graduate Degree preferred
• 5+ years experience in pharmaceutical industry, preferably directly related to clinical research
• Experience in both early and late phase clinical trials
• A thorough understanding of GCP, ICH guidelines and regulatory requirements for clinical trial management
• Knowledge of research terminology required
• Familiarity with clinical research systems such as EDC, CTMS, IRT, eTMF
• Self-motivated team player with strong attention to detail
• Strong computer literacy (Word/Excel)

The salary is competitive and commensurate with experience and qualifications.

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.