Manager (m/f/x) Project Lead, Program Management

Daiichi Sankyo, Inc.; Doderhof; On-site; EUR 90,000 - 120,000; Full time

Job summary

Daiichi Sankyo, Inc. in Germany seeks a Manager (m/f/x) Project Lead, Program Management to ensure on-time clinical supplies for studies across the portfolio, from manufacturing to labeling and distribution for Phases 1-4.

The role requires a Pharmacy degree and 7+ years' experience, with oncology exposure preferred. Responsibilities include budgeting, planning, and collaboration with SPandL and Global-PT to drive seamless clinical supply operations.

Qualifications

• University Degree in Pharmacy BS/BA
• MS or PharmD highly beneficial
• 7+ 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

Responsibilities

• Evaluate, select, and implement contract manufacturing, packaging, and labeling operations
• Negotiate work orders/proposals, in collaboration with SPandL oversee operations, and act as primary liaison with clinical personnel on assigned projects
• Participate in the design of overall clinical plans and study protocols
• Recommend type and method of packaging, labeling, and distribution
• Translate 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 detailed study-level budgets
• 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 implement as appropriate
• Assist in the establishment of SOPs and guidelines related to production planning and scheduling, inventory management, distribution, transportation, disposition of returned/unused materials

Skills

Project Management

Clinical Supply Management

Pharmaceutical Development

Oncology experience

Supply Planning tools

Education

BS/BA in Pharmacy

MS or PharmD

Job description

Manager (m/f/x) Project Lead, Program Management

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Purpose of the function

This position is responsible for enabling the on-time delivery of clinical supplies for studies across the DSI portfolio. Responsible for ensuring clinical supplies for assigned projects are manufactured, packaged labeled and distributed on time to support Phase 1-4 trials and required stability studies, with minimal supervision. This includes but is not limited to assuring availability of drug product, interpreting clinical protocols, development of Supply Plan Agreements (SPA), and generation and maintenance of study-level budgets. This position also works closely with SPandL support staff to ensure operational tasks and supply plans are executed in a timely manner.

Roles and Responsibilities

• Evaluate, select, and implement contract manufacturing, packaging, and labeling operations
• Negotiate work orders/proposals, in collaboration with SPandL oversee operations, and act as primary liaison with clinical personnel on assigned projects
• Participate in the design of overall clinical plans and study protocols
• Recommend type and method of packaging, labeling, and distribution
• Translate 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 detailed study-level budgets
• 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 implement as appropriate
• Assist in the establishment of Standard Operating Procedures (SOPs) and guidelines related to production planning and scheduling, inventory management, distribution, transportation, disposition of returned/unused materials, etc

Personal skills and professional experience

• University Degree in Pharmacy BS/BA required
• Extensive relevant experience will be considered in lieu of an advanced degree
• University Degree in Pharmacy Degree in pharmacy or related field preferred
• MS or PharmD highly beneficial
• 5 to 8 years Minimum 7 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

Why work with us

Working at Daiichi Sankyo is more than just a job - it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.