Manager, Site Budgets and Contracts

Manager 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 genetically defined 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, Site Budgets and Contracts to join our growing Clin Ops 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, Site Budgets and Contracts is responsible for executing all aspects of the clinical site contracting, negotiation and execution of required budgets and agreements in support of clinical studies. The 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 reports into the Head, Clinical Development Operational Excellence and Operations and may occasionally be asked to work on other vendor-related contracts/budgets or investigator-sponsored trials as identified

What you will do:

Site Budgets

• In close partnership with the CROs and leveraging their regional and local expertise, and working with internal Agios colleagues, develop standard site budget templates using industry grant benchmarking software and leveraging budget precedent whenever possible
• Oversee and partner with CRO on site negotiations while ensuring fair market value (FMV). Proactively identify risks with clinical site budgets, develop risk mitigation plans, and escalate appropriately during the negotiation process including direct negotiation with sites as needed.
• Maintain oversight of CROs to ensure compliant and timely execution of budget amendments
• Meet tight study deadlines ensuring sites/PI contracts are able to meet Ready to Enroll (RTE) Targets
• Ensure consistent approach to site budgets across studies/programs.
• Resolve site budget inquiries from stakeholders, i.e., Study Teams, CRO team members and Site/PIs with a sense of urgency and understanding importance of deadlines

Clinical Trial Agreements, Amendments and Ancillary Agreements

• Work with the CRO and Agios Legal to generate approved study agreement templates. Leverage existing master and historical site agreements and CRO expertise wherever possible.
• Act as the first level of support for contract language escalations. Leverage Agios-approved fallback language and positions to expedite execution of an approved agreement. Escalate to and work with Legal to identify alternatives for any contract language that falls outside of approved language
• Coordinate and track the contracting activities across Agios studies during startup. Act as single point of contact for the CROs and conduit between Legal, CROs and sites.
• Maintain oversight of CROs to ensure compliant and timely execution of site contracts and contract amendments.
• Develop and manage the overall CTA timeline, track progress and provide regular updates to key stakeholders. Provide a portfolio level view across all studies.

General

• Able to work in a fast-paced, highly visible role
• Provide high level of customer service to PIs, Sites, CROs and Agios internal colleagues
• Excellent oral, written and presentation communication skills to ensure stakeholders are informed of budget and contract status in a timely fashion
• Excellent time management skills, ability to prioritize with deep understanding of study timelines and milestones to achieve corporate goals.
• Identify process improvements and innovative approaches to the site contract/budget process.
• Support negotiation of other vendor agreements or investigator-sponsored trials if requested

What you bring:

• Bachelor’s degree required
• Five (5) years’ experience in the biotechnology/pharmaceutical industry with at least 3 years of direct experience negotiating site budgets and contracts across late phase clinical studies in both the US and internationally
• Deep experience in negotiations, managing CROs and creative and compliant conflict resolution and problem solving
• Thorough understanding of Clinical Operations, GCP, relevant ICH standards, and FDA/EMA guidelines.
• Deep understanding of site budget structure, including key cost drivers and common negotiation sticking points
• Knowledge of and experience working with site contracts and common legal terms and conditions
• Experience using outputs from trial cost benchmarking software
• Ability to prioritize needs and handle a high volume of tasks within tight clinical timelines
• Ability to build networks and collaborate with CRO and internal stakeholders

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’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.