Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The Director, PDCS Clinical Supply Management is responsible for managing and providing leadership and direction to Clinical Supply Managers in the planning and execution of Clinical Supply Chain activities globally. This position oversees operations including clinical packaging, labeling, IRT and distribution. Responsible for overseeing Quality Systems related to the Clinical Supply Chain including deviations, investigations, CAPA's, and Change Controls. The Director will support activities leading to the implementation of global clinical inventory management, supply planning and distribution systems consistent with meeting cGMP, clinical development programs and corporate objectives. The role will also oversee vendor management including performance metrics and contractual agreements.

You will be responsible for:

• Motivating, recruiting, and developing key employees. Building and sustaining employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
• Directly overseeing contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials.
• Managing, coaching and mentoring Clinical Supply Managers. Developing best in class clinical supply area.
• Acting as primary liaison with contractor(s) (CMO's). Completing quarterly business and performance metrics. Negotiating quotes and work orders for new trials.
• Working with Clinical Operations, QA and Regulatory to develop kits and label text for multiple countries/regions and provide support for IND filings as required.
• Establishing SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with GxP requirements.
• Managing development of pharmacy manuals with appropriate internal subject matter experts.
• Managing vendor selection for clinical study support, including Clinical Packaging and Labeling facilities as required. Working with Regulatory Compliance and QA in selection/qualification of CMO's.
• Managing Quality Systems required documentation, including Deviations, Investigations, CAPA's, Change Controls, Label and Product Specifications, and others as required.
• Being a subject matter expert for clinical trial supply during regulatory inspections.
• Proactively addressing risk management issues and implementing business continuity plans.
• Preparing supply and cost forecasts as required. Identifying cost reduction opportunities and developing and managing clinical supply budget

You will need to have:

• Advanced degree preferred (PharmD, MS or MBA) in supply chain related or drug development discipline or BS/BA with equivalent qualification or experience.
• Minimum of ten years of experience in the pharmaceutical industry with focus on global clinical investigational product supply chain management. Strong understanding of GCP’s, GMP’s and ICH
• In depth knowledge of Clinical Development processes and supply chain and experience managing clinical supply managers and teams.
• Demand forecasting, supply chain planning and clinical distribution experience.
• IRT set up and implementation experience with blinded and non-blinded trial requirements
• Working knowledge of global regulatory environment impacting the provision of investigational products
• Ability to review documentation, processes and procedures as it relates to clinical trial activities, identify issues/problem areas and assess compliance.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Experience with regulatory submissions a plus.
• Import/export knowledge desirable.
• Proven ability to select, secure and manage external vendors at a senior manager level to achieve results and control expenditures

#LI-SM1

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.