About the Role:
Supports the planning and organization of the working team and independently plans and organizes tasks to meet specified objectives and timelines. Manage the supply planning and delivery of development products by supporting clinical supply management, IWRS, distribution, logistics planning and clinical supply budget development and tracking. Manage and execute the clinical supply chain for current and new clinical studies and programs.
This is a non-supervisory position
This role oversees vendors and/or contractors
Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Own the coordination and execution of all clinical supply related activities including supply planning, distribution, and logistics for all clinical programs
- Knowledge of clinical production processes and design strategy for patient kits to support the clinical study design.
- Support the IWRS User specifications and UATs.
- Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs
- Coordinate Supplier Relationship Management for all clinical suppliers to which includes maintaining key performance metrics and budget/invoice tracking
- Support Global Supply Chain in all current and future Global Product Teams for clinical supply strategy and execution
- Assist in the management of the governance committee for global clinical operations and global clinical supply chain
- Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results
- Assist in the execution of clinical supply strategy for specific clinical programs
- Understanding of the roles and responsibility of all functions represented on cross functional drug development teams.
- Bachelor's Degree in science or business related field; Masters/MBA in Operations preferred
- Minimum 7 years of experience handling / leading clinical supply chain and logistics; some development experience preferred
- Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams
- Demonstrated ability to work in a highly matrixed environment is essential; ability to develop and lead a high performing team across all levels
- Experience in multi-functional areas (Clinical, Regulatory, Quality) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP.
- Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment
- Extensive in planning and execution of investigational materials supply strategies
- Some travel, both domestic and/or international may be required
- Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
- Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
- Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.