The Manager, Clinical Supply Chain is responsible for planning and support on multiple clinical programs working closely with Supply Chain project leads and Clinical Operations. This includes work on complex programs that may require multinational interactions.
The position will collaborate closely with CMC subject matter experts, quality assurance, regulatory, and clinical operations to ensure compliant and timely supplies of clinical trial material are available to support clinical programs.
The position will manage operational elements of Supply Chain projects/programs in a lead role, will analyze complex sets of data and apply appropriate methods to improve processes, and will influence and guide the Supply Chain team to execute on required activities in order to achieve strategic goals.
May directly manage direct reports, but also operates as an individual contributor. May lead non-complex functional teams and initiatives.
- Review clinical trial protocols and understand impact to identify demand assumptions based on enrollment rate, number of sites, number of countries, etc.
- Create, review, and update clinical supply and demand plans.
- Communicate and update clinical supply requirements on study and program levels to supply chain project leads and ensure seamless coordination of demand and supply.
- Ensure changes in supply configuration, trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered.
- Configure RTSM systems and participate in User Acceptance Testing.
- Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk, and develop risk mitigation plans.
- Communicate with external service providers on project requirements.
- Achieve operational objectives by contributing information and recommendations to strategic plans and budget reviews.
- Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- Other duties as assigned.
- Bachelor’s degree required; Master’s degree or MBA preferred plus 5+ years of relevant experience in the biotechnology / pharmaceutical industry, with a minimum of 3 years in clinical drug supply preferred.
- Strong ability to collaborate and build strategic relationships with internal (clinical operations, quality, product/technical development, R&D…etc.) as well as external (CMO, CRO, etc.) stakeholders.
- Experience working within a cGMP operational or supply chain environment is required.
- Experience in CMO and CRO management, including labeling, packaging, and global distribution is required.
- Proven ability to successfully operate a clinical supply chain partly based on outsourced capabilities, especially the management of contract manufacturing organization is critical.
- Experience with IRT and ERP systems.
- Knowledge of cGMPs and relevant FDA, EU and Global Regulations.
- Familiarity with US and EU regulatory agencies and their guidance.
- Ability to multi-task and work in a fast paced and dynamic environment.
- Strong working knowledge of standard business software, including MS Excel, Word, PowerPoint and Project.
- Strong analytical and organizational skills – Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions.
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org