Senior Clinical Supply Chain Specialist

Alkermes Overview

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global  biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. The following position is for Alkermes, Inc.

Position Summary:

The Senior Clinical Supply Chain Specialist is responsible for the clinical planning and support on multiple clinical programs working closely with Supply Chain project leads and Clinical Operations. This includes work on complex programs that may require multinational interactions. Monitor enrollment activity and inventory levels and provide feedback to Supply Chain project lead regarding expiry and resupply. Assist with clinical label development and oversight of clinical product distribution. Participate in development, review and acceptance testing of IXRS. Coordinate returns from clinical sites and destruction of trial materials. Serve as a key customer liaison with multiple functional areas.

Essential Areas of Responsibility:

• Review clinical trial protocols and understand impact on supply

• Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.

• Assist with the creation, review, and updating of clinical supply and demand plans, and as appropriate use simulation tools to drive optimal clinical supply efficiency

• Communicate and update clinical supply requirements on study and program levels to Supply Chain project leads and ensure seamless coordination of demand and supply

• Ensure changes in supply configuration, trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered

• Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues

• Coordinate shipping oversight of clinical product to both US and OUS locations

• Manage drug returns process and site close-out activities. Prepare drug reconciliation reports.

• Assist with label management for clinical product

• Assist in development of IXRS and participate in User Acceptance Testing

• Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans

• Communicate with external service providers on project requirements. Review quotes from providers.

• Achieve operational objectives by contributing information and recommendations to strategic plans and budget reviews

• Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations

• Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments

• Develop strong internal collaboration with stakeholders to ensure customer satisfaction

• Track project spend against approved budget

Basic Qualifications and Minimum Education:

• Bachelors in life sciences or business major required

• Minimum 3-5 years in life sciences industry related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination

• At least 3 years direct experience in clinical supplies environment

• Proficient knowledge of Microsoft Excel, PowerPoint and Project software required

• APICS certification (CPIM, CRIM, CSCP) preferred Physical Demands and Work Environment:

• Travel domestic and international – up to 15%

• In-house position based in Waltham, MA Preferred Qualifications and Competencies:

• Good understanding of clinical study design, execution, and impact of study drug supply

• Demonstrated knowledge of clinical trial process from study start up through trial completion

• Familiarity with various clinical trial designs (randomized, double-blind, double-dummy, placebo controlled, cross-over, etc.)

• Demonstrated experience in inventory management and forecasting drug supply needs globally

 • Experience with IXRS systems and managing the forecasting and planning of drug supply needs

• General knowledge of GMP and/or GCP

• Familiarity with handling of controlled substances and DEA regulations

• Demonstrates flexibility through adapting to external environment influences through development of new strategies and tactics

• Excellent communication and influencing skills, strong collaboration skills

• Strong attention to detail

• Ability to multi-task and manage complexity

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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