Associate Director, Clinical Supply Operations

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position is responsible for enabling 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 SP&L support to ensure clinical supplies for assigned programs are manufactured, packaged, labeled and distributed on time to support Phase 2 - 4 trials and required stability studies, with no supervision. This includes but is not limited to assuring availability of drug product, interpreting clinical protocols, development of complex Supply Plan Agreements (SPA), and generation and maintenance of numerous study-level budgets.
This position is also responsible for significant budget development and control given the comparator sourcing and GMP processing costs associated with later stage program support.

Responsibilities:

• Understands the overall Compound Development Plan (CDP) and critical longer term deliverables for CSO. Makes recommendations for strategic placement of work to CSO management based on CDP requirements. Manages the planning and execution of CSO work streams in close collaboration with SP&L support.
• Actively participates in the design of overall clinical plans and study protocols by ensuring CSO strategies are incorporated into the final output. Recommend comparator sourcing strategies and optimal method of packaging, labeling, and distribution. Translates protocol requirements and study milestones into an actionable Supply Plan Agreement
• Collaborate with clinical teams on forecasting and delivering supply assessments to the appropriate planning functions within Global-PT. Develop both detailed program and study-level budgets frequently involving high value comparator products.
• Recommend matching placebo and comparator drug sources. Develop appropriate blinding strategies and coordinate team efforts for analytical method development, stability studies and regulatory CMC filing (domestic and international).
• Identify emerging trends, technologies, and best practices and work with CSO management to implement change as appropriate.
• Drive the development or enhancement of Standard Operating Procedures (SOPs) and guidelines related to production planning and scheduling, inventory management, distribution, transportation, disposition of returned/unused materials, etc.

Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

• BS/BA required. Degree in pharmacy or related field preferred. MS or PharmD highly beneficial.
• Minimum 9 years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. Oncology experience is preferred. Creation of Supply Planning tools is preferred.

Ability to travel up to 10%

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.
Job Title
Associate Director, Clinical Supply Operations

City
Basking Ridge

Functional Area
Pharma Technology

State
New Jersey