Manager, Clinical Vendor Outsourcing

Manager, Clinical Vendor Outsourcing

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, Clinical Vendor Outsourcing to join our growing Clinical Operations team. We want someone who cares about this important work and is driven to connect to our mission of helping our patient communities. The Manager, Clinical Vendor Outsourcing is responsible for relationship management, strategic insight, tactical support and execution of end-to-end outsourcing activities required to successfully execute clinical studies in a fast-paced and dynamic environment. They will partner cross-functionally to lead the selection, contracting, and ongoing management of the vendors who help make our trials successful. This role will report to the Associate Director, Clinical Outsourcing.

 What you will do:

• Leveraging vendor knowledge and experience, individual will lead vendor selection activities through collaboration with Clinical Operations and others on the study team. Includes but is not limited to: identifying vendors, gathering business needs, leading RFPs, proposal reviews and bid defense meetings, scoring and award discussions, contract reviews, negotiating budgets and payment schedules, and executing contracts through the company’s Contract Management System. 
•  Manage contracting activities including preparation, finalization, and administration of CDAs, Service Agreements, Work Orders, Change Orders, and Amendments for assigned studies and/or program(s).
• Facilitate study kickoff meetings to clarify timelines, statements-of-work, roles and responsibilities, and budgets.
• Support the management of vendor relationships, ensuring Agios expected outcomes are met or exceeded
• Monitor the outsourcing environment to keep current on providers and industry trends.
• Collaborate effectively with all relevant functional departments (e.g., Legal, Quality Assurance) to ensure appropriate review and approval of clinical vendors and vendor contracts.
• Identify, lead, and participate in vendor outsourcing and other Clinical Operations process improvement projects
• Collaborate with QA and compliance to ensure quality management of vendors
• Management and oversight of study budgets for assigned studies including:
• Maintaining established tools/trackers for management and oversight of study budgets for contract tracking purposes, and tracking budget to actual metrics
• Proposing trade-offs within the study budget portfolio
• Scheduling and leading study team financial reviews
• Upon request work with Outsourcing leaders to contribute to annual budget review and Long-Range Planning (LRP) processes

What you bring:

• Bachelor’s degree required. MBA or advanced degree preferred
• Minimum 5 years’ experience in the biotechnology/pharmaceutical industry with 3 to 5 years of direct experience in clinical vendor selection and budget/contract negotiation across early and late phase clinical studies in both the US and internationally
• Working knowledge and understanding of clinical trials budgeting software
• Experience and proven skills with study budget and project management
• Excellent 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
• Excellent analytical and problem-solving skills; ability to think on your feet and act with a consistent sense of urgency
• 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
• 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.
• Ability to create and collaborate with vendors and internal stakeholders
• Ability to work both independently and in a team environment.
• 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.
• We are all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you are at your best, we are 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 are continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We are 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 often overlooked.

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