Blueprint Medicines is seeking an exceptional candidate for a Senior Manager of Investigational Supply Operations. This individual will design, develop, and implement the clinical supplies strategy at the program level to ensure appropriate processes are established and in order to achieve clinical supplies key deliverables for each study within the program. This position reports to Head of Investigational Supply Operations. The candidate will have an opportunity to join a rapidly growing Pharmaceutical Sciences organization, manage supply chain activities for Phase I through commercialization and assist in the development and implementation of Investigational Supply Operations processes and procedures.
- Plans, establishes, manages and monitors forecast activities related to drug substance, drug product, and clinical supplies at the program and study level.
- Responsible for all levels of studies, ranging from simple and complex, requiring in-depth understanding of GMPs, project management, IXRS, medication management and/or use of advanced simulation tools.
- Independently responsible for conceptualization, development, and implementation of clinical supply plans, based on CMC and clinical development plans.
- Responsible for scheduling and delivery of CTM including strategies for creating label and packaging design, randomization, packaging, labelling and distribution of clinical supplies.
- Manages external consultants and third party vendors, including vendor selection and agreement development, to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements. Ensures that key project milestones are met, negotiates and communicates supply plan timelines to internal and external customers and partners.
- Develops and manages the forecasting and ordering investigational product, commercial and comparator material in global trials and share best practices with global/local sourcing teams as appropriate.
- Independently creates clinical supply study budgets. Monitors spend to-date compared to the approved study budget. Accountable and responsible for amending budgets through defined change management processes. Manages all finance activities with clinical team including request for proposal for bidding and vendor selection, purchase orders and invoice approval.
- Ensures uninterrupted supplies throughout the duration of a clinical study program. Maintains/tracks inventory of available clinical supplies and tracks expiration dates. Coordinates with CMC, in-licensing and QA partners to manage technical and quality issues to facilitate uninterrupted supplies.
- Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects. Identifies potential system/technology improvements/enhancements.
- Maintains and ensures compliance to all SOPs. Identifies gaps and makes appropriate mitigation recommendations to ensure global compliance. Develops new functional SOPs, as necessary. Provides training to staff.
- B.S. degree in life sciences, chemistry or equivalent and 7 years in the management of CTM packaging and labelling, including CTM for international studies, preferably within the pharmaceutical industry. At least 3 year of project management experience.
- Experience working with CMC Teams.
- Experience managing relationships with CMOs/CROs.
- Strong organizational and forecasting skills.
- Knowledge of Interactive Response Technologies (IRT) for use in clinical studies.
- Ability to effectively prioritize and manage multiple projects and tasks
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk based decisions
- At home in a results-driven, highly accountable environment where you can make a clear impact
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
WHO WE ARE:
Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.
We don’t think in small steps. We think in giant leaps.
We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.
We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.