Program Lead/Associate Director CSO in Bernards, NJ at DSI

Date Posted: 1/13/2022

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Experience:
    Not Specified
  • Date Posted:
    1/13/2022
  • Job ID:
    R211

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 both medium and high complexity programs with significant technical and geographic complexity across the DSI portfolio. 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 1 - 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 position is also responsible for supporting budget tracking by sharing actual GMP processing activities versus plan to CSO Project Mgmt.


Responsibilities
  • Facilitation of monthly D&OP process for medium to high complexity compounds. Scheduling and executional oversight of outcomes from D&OP process
  • Management of CMO / vendors for scheduling all packaging, labeling, distribution activities to meet study milestones. Includes issue resolution with Quality Assurance
  • Participate in continuous improvement initiatives designed to enhance process and technology across CSO
  • Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs
  • 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
  • Degree in pharmacy or related field preferred
  • Master's Degree preferred or
  • 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.