Sr. Manager, Clinical Drug Supply Logistics

Location
Tarrytown, NY, United States
Posted
Jun 30, 2019
Ref
17026BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

The Clinical Drug Supply Sr Manager role is a key leadership role within Global Clinical Operations. The role holder will be responsible for translating clinical study designs and key planning parameters into robust demand forecasts and predictions for the planned use of clinical supplies across the portfolio. Additionally, he/she will manage the supply chain for multiple clinical studies across all phases within a drug development program. He / she will lead cross-functional Drug Resource Utilization Group (DRUG) teams and represent these teams on various Clinical and CMC subteams. Competencies include advanced drug demand forecasting and scenario planning, packaging and labeling, global distribution, IRT technology, outsourcing management, capacity and performance metrics, project management, and conformance of quality and compliance requirements.

• Supports Clinical Drug Supply Managers though the creation of demand forecasts and implemention of robust supply plans using advanced simulation and optimization technologies.

• Responsible for optimizing demand through the analysis of multiple scenarios and comparing associated cost and risk to identify the best-fit supply strategy.

• Collaborates with Clinical Drug Supply Managers to prepare and present study-level forecasts and demand plans to key stakeholders within Global Development and IOPS.

• Manages the drug supply component of the Operational Development Plan (including, packaging/labeling strategy and distribution)

• Provides/assists to provide Industrial Operations and Product Supply (IOPS) program specific manufacturing and packaging requests, and prioritizes the associated work.

• Advises Clinical Drug Supply & Logistics (CLO), IOPS and Clinical management of resource constraints and recommends strategies which will influence the ability of CLO to meet existing or anticipated demands.

• Oversee the distribution/logistics activities of complex supply chains by evaluating supply strategies, tracking inventories, tracking expiry dates, initiating bulk shipments, and coordinating import/export requirements to minimize time to drug availability at sites.

• In collaboration with IRT Manager, manages IRT development activities including participation in User Acceptance Testing plans which augment and operate in conjunction with the vendor UAT to ensure the IRT is in line with clinical trial needs.
Demonstrated experience in clinical forecasting including the ability to translate complex clinical trial designs into demand forecasts and supply plans to meet business objectives.

• Prior experience with forecasting and simulation optimization software preferred.

• Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.

• Ability to multi-task and work in a fast paced and dynamic environment

• Track record of good project management.

• Risk identification and management.

• Excellent written and verbal communication skills.

• Degree in supply chain related or drug development discipline or equivalent qualification or experience

• Extensive experience (6+ years) working in clinical supply chains

• Significant experience in forecasting and supply planning

• Working knowledge of the EU Clinical Trial Directive, Good Clinical Practice (GCP) and global regulatory environment impacting the provision of investigational products

• In depth knowledge of R&D supply chain and drug development process

• In depth knowledge of Clinical Development processes relevant to the supply of clinical materials

• Extensive

• Experience of project management

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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