Senior Manager, Clinical Supply Chain

Planet Pharma; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Agios is seeking a dynamic Senior Manager to join our Clinical Supply Chain team. You will lead end-to-end drug supply activities for clinical trials globally, including forecasting, labeling, packaging, IRT setup, and distribution in collaboration with CMOs/CROs.

You will partner with Clinical Operations, QA, CMC and Regulatory Affairs to ensure compliant, timely delivery while driving continuous improvement and risk mitigation. Travel about 10-15% is expected.

Qualifications

• B.S. in pharmaceutics, chemistry, biology, material science, chemical engineering 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 with ISTs, EAPs, and Single Subject IND / Named Patient requests.
• Travel 10-15% and ability to navigate a fast-paced, matrixed environment.

Responsibilities

• Drive clinical supply activities for ongoing and new clinical trials, including forecasting, monitoring, resupply planning, label design, packaging vendor management, IRT setup and distribution.
• Manage label development and production planning with established CMO vendors.
• Partner with CROs for efficient utilization of drug supply materials.
• Collaborate with Clinical Ops, QA, CMC and Regulatory Affairs to ensure compliant delivery of clinical supplies.
• Develop risk mitigation plans to address potential supply issues and support leadership across functions.
• Lead continuous improvement initiatives to reduce lead times and supply risks.

Skills

Project management

Communication skills

Cross-functional collaboration

Experience with CMOs/CROs

ISTs/EAPs/IND

Matrixed environment

Education

B.S. in Pharmaceutics, Chemistry, Biology or related field

Tools

Signant Health SmartSupplies

PMD software

IRT vendors/systems

Job description

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%)