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Associate Director Clinical Supply Systems

Employer
Regeneron Pharmaceuticals, Inc.
Location
Basking Ridge, New Jersey, United States of America
Start date
Jul 14, 2021

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time

Job Details

The Associate Director, Clinical Supply Systems within Clinical Drug Supply and Logistics is responsible for leading the Interactive Response Technologies (IRT) Group for Regeneron's global portfolio of clinical studies. The primary responsibilities for this role include the oversight and continued evolution of Regeneron's strategy in supporting vendor governance, standardizations, and delivery while maintaining a high level of operational delivery in a multifaceted environment across multiple therapeutic areas. The role collaborates with several functional areas such as clinical trial management, data management, biostatistics, and clinical supply leads.

In this role, a typical day may include:
  • Leading a top-tier IRT team to service the diverse and vigorous clinical study portfolio within Regeneron while striving to continuously improve
  • Managing external third party IRT vendors and ensureing alignment with business partners in Vendor Relationship Management and Strategic Sourcing & Procurement to ensure operational and strategic deliverables are maintained through established KPIs
  • Developing innovative solutions that provide continuous improvements in cost and quality
  • Evaluating ongoing performance for third party vendors and working to continuously identify and address area for operational alignments and improvements
  • Maintaining awareness of industry innovations and optimal practices, continuously evaluating innovative new technologies to ensure IRT maintains excellent performance
  • Guiding and supporting internal IRT teams through inspection preparations and maintaining inspection readiness
  • Encouraging internal and external business partner relationships that support the success of Regeneron trials
  • Managing operational oversight for IRT data governance and connectivity in alignment with the rest of the organization
  • Ability to travel up to 25%


This role might be for you if:

You have comprehensive knowledge of the IRT terminology and SDLC oversight

You have knowledge of ICH/GCP and regulatory guidelines/directives

You're a proven leader with strong mentoring and coaching skills

You are adept at project management with strong organizational skills and the ability to negotiate and influence across all levels of an organization

You have cross-functional and cross-cultural awareness

You have the ability to work in a fast-paced, matrix environment with a high level of ambiguity

To be considered, you'll need a Bachelor's degree and at least 10 years of proven experience in the biotechnology/pharmaceutical industry, with minimum 8 years working directly in an IRT environment. Experience developing IRT systems for clinical trials is also vital.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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