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Senior Manager, Clinical Drug Supply & Logistics

  • One Source Managed Solutions (Hiring for Confidential Company)
  • Bernards, NJ, 07920
  • Full Time
  • Master's Degree
  • Experienced

Posted on

Job Description:

Summary

The Senior Manager, Clinical Logistics is responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations/guidelines and SOPs / WPDs. Contributes and drives ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability).


Responsibilities

 

Supply Planning

  • Serves as lead logistics manager for the functional area in supply planning, including demand forecasting according to IOPS requirements; Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan; Works with clinical logistics management to determine resourcing needs; Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals; Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines; Oversees setup and management of IVRS (IWRS)

Inventory tracking

  • Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends.

Shipments

  • Oversees IP shipment orders according to supply plans or as requested by the Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process.

IVRS

  • Extensive knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS; Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors. Lead effort for clinical supply management functionality; Monitor and manage clinical supply activities through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred to TMF and inspection readiness.

Temperature excursions

  • Reviews and evaluates temperature excursion data and communicates stability information to clinical trial managers, CROs, and investigator sites; provides assessments to supply management team regarding excursion trends in each study.

Returns & Destruction

  • Reviews drug return and destruction records; communicate with investigator sites, CROs and external vendors to resolve issues.
  • Authorizes final destruction of drug returns to 3rd party vendor.

Expiry Management

  • Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.

Ancillary Supplies

  • Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.

Documentation

  • Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists; Reviews IVRS specs and reviews IVRS user manuals; Designs, reviews and approves IP-related study tools (for clinical study teams and investigative site use), as needed. Supports the inspection team in preparation for and during regulatory agency inspection.

Study Team Interaction

  • Represents Clinical Logistics/Supply Management on cross-functional study team (s) and/or sub-team(s); Provides input into budgets, SoWs, contracts and timelines for IP-related services; Prepares or provides input into IP-related content for training materials and coordinates training on study procedures; In collaboration with the CTM for study, provides input into IP-related study specific working practices; Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; Develops, manages, and maintains relationships with external partners; Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues.

Vendor Management

  • Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); Provides input, reviews, and approves vendor study specifications; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated; Recommends vendors to IOPS and Clinical Study Teams.

Staff Management

  • May or may not supervise staff. If supervising staff, manage staff's daily activities to implement plans, as appropriate.
  • May mentor or coach junior Clinical Logistics staff.

Process Initiatives

  • Develop and implement process initiatives in accordance with business needs.

Metrics

  • Develop and evaluate metrics related to drug supply processes and staff.

Training

  • Provide training and development as needed.

Reporting

  • Compiles and reports supply status to study teams and senior management

Problem-solving

  • Applies knowledge of company policies and standard practices to resolve problems.

 

Experience And Required Skills :

  • Experience developing trial drug supply plans
  • Investigational Product forecasting skills
  • Working knowledge of the clinical drug development process and clinical trial methodology;
  • Knowledge of ICH/GCP and regulatory guidelines/directives
  • Disease/therapeutic area knowledge (a plus)
  • Understands current and future business trends and information
  • Leadership and negotiation skills
  • Mentoring/coaching skills
  • Ability to effectively multi-task and prioritize
  • Effective problem-solving skills
  • Written and verbal communication and presentation skills in small and large group settings
  • Project management and organizational skills
  • Computer skills, with competency in MS Word, Excel
  • Study Tools including electronic system skills IVRS/IWRS, CTMS, EDC
  • Interpersonal skills
  • Cross-functional and cross-cultural awareness
  • Ability to work in a matrix environment.

Success factors:

  • Integrity and Trust
  • Negotiating
  • Dealing with Ambiguity
  • Learning on the Fly
  • Managerial Courage
  • Directing Others
  • Process Management

Education

  • Bachelor’s degree
  • Minimum of 6 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management. 
  • Some line management experience, if applicable.

Company Description:

Our Client is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, their unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in their own laboratories. Their medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.