Senior Program Lead/Director, CSO in Basking Ridge at Daiichi Sankyo

Date Posted: 5/9/2022

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This position is responsible for the on-time delivery of clinical supplies for highly prioritized programs with the highest technical and geographic complexity across the DSI portfolio. Provides strategic leadership and oversight to key service providers on an ongoing basis. Works closely with assigned Project Mgmt representative to ensure clinical supplies for assigned programs are manufactured, packaged, labeled and distributed on time to support Phase 2/3 - 4 trials, with no supervision. This includes but is not limited to demand forecasting, monthly D&OP process facilitation, daily management of CMO / vendor interactions and contribution to continuous improvement initiatives. This individual possesses deep experience with all aspects of clinical supply execution activities and is a mentor for more junior staff.
This position is also responsible for supporting budget tracking by sharing actual GMP processing activities versus plan to CSO Project Mgmt.
Responsibilities
  • Enhancement and facilitation of monthly D&OP process for high complexity compounds. Ensure scheduling and executional oversights of outcomes from D&OP process are consistently achieved. Drive improvements to SP&L and D&OP ways of working from both a process and technology perspective.
  • Strategic management of CMO / vendors for scheduling Quarterly Business Review meetings, all GMP processing activities to meet study milestones. Includes issue resolution with senior members of internal and external Quality Assurance groups.
  • Participate in continuous improvement initiatives designed to enhance process and technology across CSO.
  • Mentors junior staff on best practices for planning and executing SP&L core job responsibilities.
  • Identify emerging trends, technologies, and best practices and work with CSO management to implement change as appropriate.
  • Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation. Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
  • Bachelor's Degree required
  • Master's Degree preferred
  • Degree in pharmacy or related field preferred
  • PharmD preferred
Experience Qualifications
  • 10 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. preferred
  • Oncology experience preferred
  • Creation of Supply Planning tools preferred
Travel
Ability to travel up to 10% Overnight / single-day travel will be required to go to outsourcing vendors from time to time infrequently.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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