Associate Director, Clinical 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 is seeking a dynamic, independent, and highly motivated Associate Director (AD), Clinical Outsourcing to join our Clinical Operations team. The AD, Clinical Outsourcing, with minimal supervision, will lead and manage the successful delivery of the end-to-end clinical outsourcing lifecycle, including vendor identification, RFIs, RFPs, service providers evaluation & selection, contract & budget negotiation, change orders, performance monitoring, contract closeout, and vendor governance. This role is also responsible for the ongoing management of the study budget portfolio and the development and growth of their direct report(s).

This role reports to the Senior Director, Clinical Vendor Strategy & Partnerships, and will have many opportunities to work on cross-functional team initiatives, including process optimization supporting the goals of Clinical Operations.

What you will do:

• Accepted internally as the Vendor Outsourcing SME
• Lead the development and ongoing execution of Agios’ overall clinical outsourcing strategy
• Guide the development and implementation of contracting plans, strategies, and budgets to ensure harmonization among project teams for outsourced services
• Leveraging extensive vendor knowledge and deep experience, steer vendor selection decisions through collaboration with individual Clinical Operations teams and other Clinical Development functions. Includes but is not limited to identifying vendors, conducting RFPs, and bid defense meetings, leading proposal reviews leveraging vendor scorecards, negotiating service descriptions, budgets, and payment schedules, and executing contracts through the company’s Contract Management System.
• Manage all contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments.
• Conduct and support the qualification and evaluation process for new service providers
• Support teams in the resolution of study specific service provider performance issues. Facilitate and/or attend lessoned learned meetings as necessary to incorporate improvements in new projects.
• Facilitate study kickoff meetings to clarify timelines, statements-of-work, roles and responsibilities, and budgets
• Manage 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
• Leverage company processes to manage vendors according to defined governance and oversight processes – establish KPIs, conduct periodic governance meetings, establish escalation pathways
• Identify, manage, and participate in both vendor outsourcing and other Clinical Operations process improvement projects
• Collaborate with QA and compliance to ensure quality management of vendors
• Lead the management and oversight of the Clinical Operations and Data Management study budgets portfolio including:
• Building and maintaining close working relationships with Accounting and Financial partners
• 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 directing bi-monthly study team financial reviews
• Key participant in quarterly CRO Financial Reviews and Quarterly JOCs
• With Sr Director, and Finance Partners, provide quarterly and ad hoc updates to Clinical Forums and Leadership meetings
• Key participant and contributor to annual operating budget and Long-Range Planning (LRP) processes
• Identify and steer improvement projects within Clinical Operations and the broader Clinical Development team
• Develop and grow direct reports through discussion and identification of areas of focus to support their career ambitions
  
  

What you bring:

• Bachelor’s degree in business or scientific discipline required; MBA or advanced degree preferred
• At least 8 years of experience working within a pharmaceutical/biotech company, CRO, or similar organization
• At least 5 years of experience in clinical trial finance management (tracking, forecasting, and reporting)
• Expertise with Phase I-IV CROs, technical service providers, and consultants in end-to-end clinical contracts lifecycle management, contract and budget analysis, negotiation, and conflict resolution
• Business/financial acumen and thorough understanding of CRO cost models and budget as well as services and costs associated with functional service providers (e.g., IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, ECG, ePRO)
• Excellent written and oral communication skills
• Flexible and proactive
• Excellent analytical and problem-solving skills with an eye for detail
• Strong understanding of financial and compliance standards
• Able to work with minimal supervision
• Highly organized with strong negotiation skills
• Strong leadership and project management skills
• Thorough knowledge of GCP, relevant ICH standards , and FDA/EMA Guidelines
• Maintain current knowledge of outsourcing industry trends and provide ongoing support and training to key stakeholders on best outsourcing practices
• Ability to build networks and collaborate with external vendors and internal stakeholders
• Proficiency in MS Office Suite
  
  

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.