Associate Director, Site Budgets and Contracts

Associate Director, Site Budgets and Contracts 

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:

A dynamic, independent, and highly motivated Associate Director (AD), Site Budgets and Contracts to join our Clinical Operations team. The AD, Site Budgets and Contracts, with minimal supervision, will lead and manage the successful delivery of the end-to-end clinical site contracting lifecycle. This role will coordinate activities across CROs, study sites, study teams, and internal stakeholders (Legal, Finance, Compliance) to effectively deliver negotiated site agreements that balance risk and budget, while understanding and achieving key deadlines. This role is also responsible for contribution to the ongoing management of the study budget portfolio and the development and growth of their direct report(s). This role reports to the 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.

Essential Functions:

• Accepted internally as the Site Budgets and Contracting SME
• Lead the development and ongoing execution of Agios’ overall site contracting strategy
• Lead and manage a team of clinical site contracts members, including training and mentoring staff on department process and standards
• Develop and grow direct reports through discussion and identification of areas of focus to support their career ambitions
• Develop, lead, and manage clinical site contracts processes, standards and benchmarks
• Partner and build cross-functional relationships with legal, compliance, privacy, information security and other internal Agios stakeholders to deliver clinical site contracts to meet operational clinical study goals
• Work with internal Agios stakeholders to facilitate resolution of escalated issues, acting as first point of contact for team escalations
• Involvement and guidance over some aspects of HCP contracting/payment/tracking
• Evaluate requests for clinical trial contracts support, ensuring workforce planning and budgets to meet lifecycle of clinical study
• Collaborate with and manage external partners and other key vendors to ensure timely delivery of clinical site contracts book of work
• Lead strategic efforts, with internal and external stakeholders, to streamline operations and tools to improve contracting cycle times and reduce costs
• Develop, negotiate, track, and analyze internal and external KPIs to measure health of site contracting/payments
• Lead process improvement initiatives that impact clinical site contracts and the broader department and train key stakeholders
• Lead and/or oversee trial cost forecasting process and provide support and expertise for clinical trial budgeting
• Represent the department in cross-functional R&D initiatives
• Undertake additional projects, as assigned, in support of Agios R&D

What you bring:

• At least seven (7) years of experience working within a pharmaceutical/biotech company, CRO, or similar organization
• At least six (6) years of experience in clinical trial site budget and contract management (tracking, forecasting, and reporting)
• At least two (2) years of experience leading and developing direct reports in a remote or hybrid work environment
• Bachelor’s degree in business or scientific discipline required. MBA or advanced degree preferred
• Demonstrated excellent verbal, written, and interpersonal communication skills.
• Flexible, proactive, and able to work with minimal supervision.
• Excellent analytical and problem-solving skills with an eye for detail.
• Demonstrated understanding of clinical operations and study start-up
• Proficient with common budget development and data tools (e.g. Grant Plan, GrantsManager)
• Demonstrated understanding of regulatory / legal issues related to clinical trials conduct
• Demonstrated experience with driving global site contracting negotiations using proven methods for contract strategy and a clear understanding of anticipated challenges
• Extensive experience with site payments management and escalations
• Strong relationship building, negotiation, and conflict resolution skills
• Thorough knowledge of GCP, relevant ICH standards, and FDA/EMA Guidelines
• Maintain current knowledge of industry trends and provide ongoing support and training to key stakeholders on best site contracting practices
• Proficiency in MS Office Suite

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 three (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’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.