Director External Partnerships Clinical Supplies

Conteúdo do emprego

Johnson & Johnson Janssen Research & Development Inc., part of the J&J Family of Companies is recruiting for a Director, External Partnerships Clinical Supplies! This position is flexible to any J&J location with preference for Wayne, PA, Titusville, NJ & Beerse, Belgium.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie%20yacco/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. is part of the Janssen Pharmaceutical Companies.

The Director, External Partnerships Clinical Supplies is responsible for clinical supplies from the DPDS CSC external network according to preset objectives on capability, compliance, cost, time, and services. The role is responsible for overseeing a group of Contract Account Managers and execution specialists focused on P&L operations at external vendors. The role will also focus on governance for the CMO network for clinical supplies for P&L and Logistics as well as comparator vendors.

• Managing packaging and labeling of clinical supplies at CMO network
• Assuring timely delivery of clinical trial material from the clinical supply chain global CMO network
• Leading Operations activities in the DPDS CSC P&L external partnership network
• People leader role assists with budget management at a functional and DPDS level and influences sourcing of new programs/compounds.
• Manage external network relationships for P&L, Logistics
  

They build and maintain on the Global CMO network and partner with other DPDS functions, JSC, JRP and QA to assure all logistical, quality & technical elements are in place for RFT delivery of clinical material.

Key Responsibilities:

• Provide strategic and operational leadership for external network for P&L
• Manage and assist for budget and resource allocation in CSC consistent with Janssen R&D and DPDS objectives and timelines.
• Lead the Operations teams and activities in the External P&L network.
• Lead and develop a global group of Contract Account Managers (CAM) responsible for:
• Acts as the clinical supply chain project and team leader for one or more vendors where external P&L activities are involved.
• Represents the P&L Operations at the CSC P&L Operations meeting and the CSC sub team and in the relationship with DPDS and JSC stakeholders/partners
• Support optimizations and / or changes to existing capabilities and capacity
• E2E responsibility for the packaging of clinical trial material meeting the clinical demand schedule.
• Drives team problem solving and acts as a coach to team members to drive their technical and personal development.
• Demonstrates ability and experience to work in a highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines) is required.
• Setup of the required cross-linked information platforms (QA, Manufacturing, DPDS/JSC…)
• Review Master Service Agreement and define Scope of Work and performance indexes at CMO’s
• Define and follow-up on project, FTE and budget planning
• This role holder and their team must be able to work with Contract Manufacturing Organizations to perform capability assessments and provide technical expertise to influence and bridge gap analysis to meet Clinical Trial Material requirements.
• Able to independently set actions and follow ups understanding DPDS, CSC and global JSC Planning, and PES organizations’ needs, connecting effectively with management, stakeholders and partners.
  

Education

Qualifications

A minimum of a Bachelor’s or equivalent University degree is required, with a preference for a degree in life sciences, engineering or supply chain

Required

Experience & Skills:

• A minimum of 10 years of proven success and leadership in pharmaceutical or clinical development, or global supply chain management.
• Good knowledge and understanding of clinical supplies (overall process, operational and supply chain aspects), or equivalent experience inside a supply chain with high demand variability, short lead times and complex product portfolio is required.
• Strong knowledge of S&OP processes is an asset
• Demonstrated ability in managing a global customer base and / or network of stakeholders.
• Excellent people management and leadership skills; A proven ability to execute and get results through leading others. Proven track record of developing people to leadership roles. Experience in leading a global or multisite team is a plus.
• Ability to lead, inspire and influence team through a period of high change
• Knowledge of equipment engineering and qualification, regulatory guidance, manufacturing, EHS guidelines and project management for packaging.
  

Other:

• This position may require up to 25% of Domestic & International travel.
  

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]

Primary Location

United States-Pennsylvania-Wayne-955/965 Chesterbrook Blvd

Other Locations

North America-United States-New Jersey-Titusville, Belgium-Antwerp-Beerse

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206056625W