Senior Director, Clinical Logistics

Location
Tarrytown, New York
Posted
Mar 20, 2018
Ref
10308BR
Required Education
Masters Degree/MBA
Position Type
Full time
Position Summary

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.

Summary:
The Director/Senior Director Clinical Drug Supply & Logistics is responsible for ensuring adequate Investigational Product (IP) supply across all clinical programs (Phase I through IV) and for leading the Clinical Drug Supply & Logistics team. Responsibilities include forecasting supply requirements across the clinical portfolio and managing the IP distribution process on time, within budget and with good quality, in compliance with Health Authority regulations /guidelines and Regeneron SOPs. Collaborates and interacts with key stakeholders within Clinical Trial management, Therapeutic Area Project Management, and Medical Directors, as well as Quality, Clinical Compliance, Regulatory, Formulations, and Industrial Operations (IOPS). Interacts at a visible level with internal senior level management, external vendors, and collaboration partners and is a member of the Clinical Project Management and Operations (CPMO) Senior Leadership team.

Responsibilities:
• Oversees supply planning to ensure adequate supply levels and coordination of timely supply distribution. This includes demand forecasting according to IOPS requirements and in alignment with the overall clinical development plans
• Provides oversight to ensure adequate tracking of investigational product (IP) inventory across all programs and advises CPMO leadership and Program Teams of potential issues and/or shortages related to IP supply
• Responsible for ensuring IP service vendors provide quality deliverables/services/products on time and within budget across all programs and serve as point of escalation for clinical logistics team
• Oversees ancillary supply management ensuring program needs are met with quality on time and within budget.
• Acts as the key liaison between Global Clinical Development/CPMO and Industrial Operations (IOPS)
• Ensures the Clinical Supply team is working cross-functionally to develop specifications and user testing for interactive Response Technologies (IRT) such as IVRS and IWRS of IRT systems provided by 3rd party vendors; Ensure clinical supply activities are being managed through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred to Regeneron for TMF and inspection readiness.
• Direct line management responsibilities of Clinical logistics staff within which includes: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
• Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
• Supports inspection team in preparation for and during regulatory agency inspection.
• Develops, implements and contributes to ongoing process improvement initiatives as it relates to Clinical Logistics to drive operational efficiencies

Requirements:
Bachelor's degree (advanced degree preferred) and at least 12 years of relevant experience (Director-level; 15 years of relevant experience for Senior Director-level) in the biotechnology/pharmaceutical industry, with 8 years minimum in clinical drug supply. At least 5 years line management experience.
Strong leadership skills;
Must be able to effectively communicate to all levels of the organization, including senior management;
Analytical problem solving experience;
Must be able to develop and present varied and unique ideas;
Effective stakeholder management, influence and negotiation skills;
Proven Functional and Line Management skills;
Financial acumen in creating and managing budgets;
Ability to build successful collaborations with internal and external partners; Must possess strong communication skills; verbal, written, and presentation; Must have broad knowledge and cross-functional understanding of clinical trial methodology;
Working knowledge of GCP and ICH

Success factors:
Leadership
Executive Presence
Organizational & Political Savvy
Dealing with ambiguity & paradox
Stakeholder management
Strategic Thinking
Critical Thinking
Integrity and Trust
Negotiating
Directing & Leading Others
Process Management
Delegation
Innovation Management
Managerial Courage

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.

Requisition Number: 10308BR