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

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