About this role
Senior Manager, Clinical Supply Chain
This is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., company markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, our company is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. In addition to its clinical pipeline, Agios has multiple investigational therapies in preclinical development and an industry-leading research team with unmatched expertise in cellular metabolism and genetics.
The impact you will make:
This company is searching for a dynamic Senior Manager to join our growing Clinical Supply Chain team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Senior Manager role will be responsible for end-to-end drug supply management activities related to forecasting, planning, label development, packaging & labeling operations, and IMP distribution for clinical trials globally. Will represent Clinical Supply Chain both internally with cross-functional colleagues and externally with our CMO / CRO partner organizations.
What you will do:
Drive clinical supply activities for both on-going and new clinical trials. This includes demand forecasting, trial monitoring & resupply planning, label design, packaging vendor management activities, IRT set-up and distribution activities
Manage label development and production planning / operations with established CMO vendors
Partner & build relationships with Clinical Research Organizations (CRO’s) for effective utilization of drug supply materials
Work collaboratively with Clinical Operations, Quality Assurance, CMC and Regulatory Affairs to efficiently deliver clinical supplies as needed while ensuring compliance to all applicable laws and regulations
Support both Program and Protocol level leadership across all functional areas and levels of the organization
Develop risk mitigation plans to proactively identify any potential issues that may impact drug supply
Provide leadership in the development and implementation of continuous improvement initiatives to improve lead-times, accelerate speed to customer, and reduce supply chain risks
What you bring:
B.S in pharmaceutics, chemistry, biology, material science, chemical engineer or related disciplines with 3-5 years of hands-on clinical supply experience in the pharmaceutical industry
Excellent project management, organization, and communication skills
Experience working with CMOs and CROs
Experience working with Investigator Sponsored Trials (IST’s), Expanded Access Programs (EAP) and Single Subject IND / Named Patient requests
Exposure to Signant Health SmartSupplies Forecasting and PMD (Planning, Materials & Distribution) software as well as various IRT vendors / systems is a plus
Ability to navigate and be successful in a fast-paced, highly matrixed work environment
Experience with clinical label design & execution
A desire to be part of a highly innovative company with the focus on helping patients
Opportunity for travel (10-15%)
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.