- 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.
- B.S in pharmaceutics, chemistry, biology, material science, chemical engineer or related disciplines.
- 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%)
- Deliberate Development. Your professional growth as one of our top priorities.
- Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best.
- Premium benefits package. We invest in the health, wellbeing and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
- Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
- Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
- Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.
- Commitment to community. We're an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
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Senior Manager, Clinical Supply Chain - Cambridge, United States - Agios Pharmaceuticals
Description
Senior Manager, Clinical Supply Chain
Who we are:
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 rare diseases – and make a bigger difference in their lives. In the U.S., Agios 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, Agios 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.
The impact you will make:
Agios Pharmaceuticals 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:
What you bring:
Work Location:
Location Agnostic : Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
