Senior Specialist, Clinical Logistics

4 weeks ago

Santa Monica, United States Neogene Therapeutics Full time

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Position Summary

The Clinical Logistics/Sr. Specialist will be responsible for the oversight and management of cell journey activities related to the scheduling, coordination, and tracking of patient material through the vein-to-vein autologous cell journey process. This position will be responsible for overseeing all aspects of clinical logistics for one or more clinical trials at Neogene. This role must be able to work collaboratively with cross-functional teams in accomplishing such objectives. This position is based in Santa Monica, CA, and reports to the Sr. Manager of Clinical Logistics.

Essential Functions and Responsibilities

  • Serve as primary liaison for patient enrollment and cell journey across all assigned clinical trials.
  • Coordinate and schedule activities related to end-to-end process for each patient enrolling into a clinical trial, including slot scheduling, shipping/receiving of apheresis material to manufacturing, pack-out of investigational product, and shipping/receiving of investigational product at clinical site.
  • Communicate with clinical site staff, logistics vendors, and cross-functional teams when scheduling and coordinating cell journey activities.
  • Maintain patient dashboards/scheduling tool(s) used to provide traceability to completion of key milestones in cell journey.
  • Provide clinical site-facing trainings to cell journey activities to support site activation on clinical trials.
  • Assemble clinical kits for patient material collection and distribute kits to clinical sites. Maintains inventory of kits to ensure materials are readily available to support patient enrollment.
  • Lead cross-functional meeting providing high-level patient and slot updates for internal alignment and visibility.
  • Support programs, processes, and documentation of which pertain to cell journey and chain of identity (COI)/chain of custody (COC) oversight in cross-functional workstreams.

General

  • Participate in cross-functional study-team meetings to support clinical trials.
  • Identifies issues/risks and recommends process improvements and solutions.
  • Participates in the development, review, and implementation of departmental SOPs, work instructions, and processes.
  • Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence and effective communication to support a high-performing team.
  • Other responsibilities as needed.

Required Skills/Abilities

  • Demonstrates strong analytical skills to develop solutions to a variety of complex problems.
  • Can work independently and collaboratively to accomplish primary objectives.
  • Can act as a primary contact on projects or business processes.
  • Excellent interpersonal and collaboration skills.
  • Outstanding organizational skills with the ability to multi-task and prioritize planning of activities.
  • Comfortable in a fast-paced, dynamic, and highly fluid company environment and able to adjust workload based upon changing priorities.
  • Advanced data management and analytical software skills (Excel, Tableau, or similar programs)

Education and Requirements:

  • BS/BA or equivalent with 5+ years Clinical Logistics/Clinical Supply Chain experience within the pharmaceutical or biotech industry.
  • Direct experience and extensive knowledge in cell orchestration, site scheduling, and logistics.
  • Direct experience and extensive knowledge in the pharmaceutical or biotech industry, cell therapy preferred.
  • Knowledge of clinical trials and FDA requirements as they pertain to clinical trials.
  • Knowledge of domestic and international logistics/transport of biologic material for clinical trials.

The anticipated salary range for candidates who will work in Santa Monica, CA is $115,000 to $136,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

Note: At this time, Neogene is not sponsoring VISAs.

DE&I Statement

Headline: We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

  • Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
  • A collaborative culture that leverages the diverse perspectives of employees and supports courage
  • Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."

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