Assoc Mgr Clinical Drug Supply & Logistics

Location
Basking Ridge, New Jersey
Posted
May 16, 2022
Ref
REGEA0026R9020
Required Education
High School or equivalent
Position Type
Full time

SUMMARY/POSITION OBJECTIVE:

The CLO Associate Manager is responsible for providing support to CMC and Clinical teams to ensure clinical supplies are packaged, labeled and distributed on time to support Phase 1-4 clinical trials across multiple therapeutic areas. This role entails providing administrative/ management support to the Clinical Logistics Manager and Associates in all related clinical supply planning and operational activities which includes but is not limited to developing supply plans, tracking inventory, and supporting the relationships with third-party service providers. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron SOPs.

JOB DUTIES:  

Core Comptencies:

  • Provides forecasts, maintains budgets, and ensures on time delivery of clinical supplies for clinical trials; communicates supply plans to internal/ external customers and partners.
  • Coordinates the review, approval and generation of clinical label text and medication kit lists for clinical supplies.
  • Develops and implements Interactive Response Technology system for drug logistics.
  • Interfaces with QA and Regulatory groups to support the release of clinical supplies and obtaining documentation required for regulatory submissions as needed.
  • Maintains and tracks clinical supply inventory and expiration dates; accesses inventory reports and study progress for analysis against resupply plan.
  • Develops and tracks metrics to support organizational business alignment.
  • Communicates and coordinates drug shipments with vendors; reviews vendor quotes, billing and invoices and follow-up as needed.
  • Coordinates notification to QA of clinical supply temperature excursion reviews as needed; notify clinical teams of decision and directions for dispositioning.
  • Oversees the returns, reconciliation and destruction of clinical supply during the conduct and at the end of a trial.
  • Maintains and reviews appropriate IP related documentation in document management systems (eg Trial Master File, etc).
  • Attends supply chain and clinical study meetings to stay informed of clinical study status and supply needs for forecasting and planning purposes.
  • Responds to inquiries and requests from clinical teams regarding drug supply for clinical sites; communicates direction regarding resolution or actions to take as appropriate.
  • Serves as a back-up for Clinical Logistic Managers and Associates; acts as a liaison to internal and external stakeholders regarding drug supply issues.

DRUG Team Manager:

  • Collaborates with the DRUG Leader to develop and coordinate a strategy and action plan for DRUG development of assigned projects.
  • With the DRUG Leader, develops a supply development plan that includes a project schedule, project budget, resource plan and management, quality plan, and risk response plan.
  • Collaborates with the DRUG Leader to communicate project status and issues. Prepares and circulates meeting agendas and minutes as well as any reports and assessments that assist making decisions regarding project budgets, resources, and portfolio priorities.
  • Collects information and tracks DRUG milestones and metrics associated with project development.
  • Helps the members of the DRUG function effectively together. Works closely with the Leader to facilitate DRUG and subteam meetings. Acts as a backup to the DRUG Leader in his/her absence.

JOB REQUIREMENTS:

List knowledge, skills, and abilities required to perform the job.

List any preferred job requirements as well.

  • Demonstrated experience in global inventory management, forecasting global drug supply needs, global distribution of clinical supplies, use of IRT systems to assist in drug supply forecasting and site supply management
  • Has performed successfully in a matrix organization with demonstrated ability to absorb new learning.
  • Has demonstrated ability to manage time effectively, allocating personal resources across competing priorities to meet deadlines.
  • Demonstrated ability to work effectively with colleagues having a broad range of responsibilities, functional, and cultural backgrounds.
  • Experienced in leading teams or managing others, demonstrating curiosity, initiative, and energy that drives comparable performance.

Minimal educational requirements:

If years of experience in lieu of a college degree is also acceptable, please list number of years required

Equivalent experience (include # of years) in lieu of degree

High School Diploma

Associates Degree

Bachelors Degree

Masters Degree

Ph.D.

PharmD

MD

Board Certified MD

Required Licenses & Certificates:  N/A

Minimum Years of Experience:  Minimum of 4 to 5 years experience in clinical supply chain, project management, pharmaceutical development and/or clinical trials coordination.