Associate Manager, Clinical Drug Supply And Logistics

at ICON Strategic Solutions in Boise, Idaho, United States

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Remote with some travel required to the office.

Must be located in EST or CST time zone for this role.

The Associate Manager, Clinical Drug Supply & Logistics provides support for and may be responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for supporting and/or 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 Regeneron SOPs / WPDs. Will contribute to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability).

Job Duties:

Supply Planning

+ Serves as lead Drug Supply manager of multiple small and/or less complex clinical studies 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.

+ 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.

Inventory tracking

+ Manages and oversees investigational product (IP) inventory strategy; advises supply management team of potential shortages and defines resupply activities based on usage trends and projections.

Shipments

+ Oversees IP shipment orders according to supply plans or as requested by 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

+ Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.

+ Works with cross-functional teams to develop specifications and support user testing of IRT systems provided by 3rd party vendors.

+ Leads effort for clinical supply management functionality.

+ Monitors and manages clinical supply activities through IRT from study start-up through study closure.

Returns & Destruction

+ Develops strategy and oversees drug return and destruction activities.

Expiry Management

+ Develops resupply strategies based on stability and shelf-life of clinical supplies.

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

Ancillary

+ Coordinates with other functional areas, including Clinical Trial team, Medical Director, and Ancillary Supplies Manager to define ancillary supply needs.

Documentation

+ Provides input to drug kit randomization specifications and reviews and approves master kit lists.

+ Designs, reviews, and approves IP-related study tools (for clinical study teams and investigative site use), as needed.

+ Supports inspection team in preparation for and during regulatory agency inspection.

Study Team Interaction

+ Represents Clinical Drug Supply & Logistics on cross-functional study team (s) and/or sub-team(s).

+ 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.

Budget Management

+ Provides input into budgets, SoWs, contracts, and timelines for IP-related services.

+ Creates RFPs, reviews quotes, and awards third-party vendors for distribution services.

+ Responsible for distribution vendor budget management (invoice review/approval, change orders, reconciliation); reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated.

Vendor Management

+ 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 for IP-related activities.

+ May require 25% travel

Staff Management

+ Does not supervise staff.

Process Initiatives

+ Assists with developing and implementing process initiatives in accordance with business needs.

Metrics

+ Tracks metrics related to Drug Supply processes.

Training

+ May assist in 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

Qualifications:

+ Bachelor's Degree Required

+ 3 years of relevant experience in the biotechnology/pharmaceutical industry

+ 2 years minimum in Clinical Supply Management.

+ Drug forecasting experience with the IMP highly preferred.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.