Manager, Vendor Outsourcing, Clinical Operations

Who we are:

Agios 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 Manager of Clinical Vendor Outsourcing to join our growing Clinical Operations 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 Manager of Clinical Vendor Outsourcing will be responsible for creating, building, and maintaining long-lasting, mutually respectful and trusting partnerships while enabling our vendors to understand our critical business needs and contribute solutions to help deliver our life-changing therapies to patients more quickly and efficiently. In addition to successful relationship management, we want the Manager of Clinical Vendor Outsourcing to leverage their in-depth industry knowledge and authentic self for vendor governance, strategic insight and tactical support and execution of end-to-end activities required to successfully execute clinical studies in a fast-paced and dynamic environment. Responsibilities include but not limited to identification of need, request and review of RFIs/RFPs, negotiation, selection of key study vendors, contract and amendment execution, and management of study budgets. This position will work collaboratively with Clinical Operations, Clinical Development, Legal, Compliance, Finance, and other key functions.

What you will do:

• Execute end-to-end contracting activities including the development of MSAs, Work Orders, Change Orders, and approvals to ensure appropriate pricing, timely execution, and adherence to Agios requirements
• Negotiate budget, contract, and payment schedules for CROs, Central Laboratories, Imaging, ePRO and other critical study vendors for identified services to achieve maximum contract value and meet tight timelines
• Partner with Clinical Operations, Finance, Legal, Biostatistics, Pharmacovigilance, Quality Assurance, Data Management, and Clinical Development to identify vendors, conduct RFPs and Bid Defense meetings, lead cross-functional vendor selection meetings, and ensure decisions are in alignment with overall outsourcing strategy
• Lead the facilitation and management of Tier 2 and Tier 3 vendors according to defined governance and oversight processes – KPI review, periodic governance meetings, escalation pathways and relationship management 
• Manage Tier 2 and Tier 3 vendor budget to actuals to ensure compliance with annual budget targets
• Collaborate with QA and compliance to ensure quality management of vendors 
• Is the SME for resolving complex issues relating to contract negotiation and management 
• Ensure compliance with vendor selection SOPs throughout life of study 
• Request and track contracts through contract database 
• Identify and lead improvement initiatives including processes and tools development
• Participate in Corporate or Clinical Development initiatives outside of Vendor Outsourcing

What you bring:

• Bachelor’s degree required. MBA or advanced degree preferred 
• 5 years’ experience in the biotechnology/pharmaceutical industry with at least 3 years of direct experience in vendor analysis, selection, and budget negotiation across early and late phase clinical studies in both the US and internationally 
• Exceptional understanding of the broad landscape of vendors involved in successful delivery of clinical studies 
• Strategic & critical thinking supported by proven experience in negotiations, vendor management and conflict resolution 
• Ability to collaborate externally and internally
• Excellent analytical and problem-solving skills; ability to think on your one’s feet and act with a consistent sense of urgency 
• Stress resistant in a fast-paced, dynamic, and growing environment with the ability to work in the grey space and pivot as needed
• Attention to detail, and excellent organizational skills with the ability to multi-task, prioritize needs and manage a high volume of tasks within tight clinical deadlines 
• Ability to take ownership of own development & success
• Ability to work both independently and within a team environment
• Clinical Operations/Development experience with a thorough understanding of relevant regulatory requirements such as GCP, relevant ICH standards, and FDA/EMA guidelines. 
• Excellent communication (oral and written) and presentation skills. 
• Experience and proven skills with study budget and project management 
• Proficiency in Microsoft Office 

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:

• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.