Manager/Sr. Manager, Clinical Outsourcing

Manager/Sr. Manager, 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 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. In addition to its clinical pipeline, Agios has multiple investigational therapies in preclinical development and an industry-leading research team with unmatched expertise in cellular metabolism and genetics.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Manager/Sr. Manager, Clinical Outsourcing to join our growing Clinical Development Operations (ClinDev 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/Sr. Manager, Clinical Outsouring will be responsible for outsourcing and relationship management activities across our clinical vendor landscape:

• vendor selection (conducting RFPs, proposal review, budget negotiations)
• vendor governance (conducting periodic business/quality reviews, relationship management, team building)
• informing and supporting overall outsourcing strategy

This role reports into the Director, Clinical Outsourcing and will have the opportunity to work on diverse team initiatives supporting the goals of ClinDev Ops.

What you will do:

• Work with individual study teams and other functions to set sourcing strategy, identify vendors, conduct RFPs and bid defense meetings, and coordinate vendor selection decisions
• Negotiate new proposals and change orders to ensure Agios is paying fair and competitive costs
• Inform and support global outsourcing strategies and ensure alignment and implementation
• Ensure compliance with vendor selection SOPs throughout life of study
• Manage Tier 1 and Tier 2 vendors according to defined governance and oversight processes – establish KPIs, conduct periodic governance meetings, establish escalation pathways
• Implement creative activities to improve vendor working relationships with Agios stakeholders
• Review, ensure cross functional alignment and propose prioritization of any outsourcing process improvement projects
• Collaborate with QA and compliance to ensure quality management of vendors
• Identify and participate in other ClinDev Ops initiatives outside of clinical 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 selection and budget negotiation across late phase clinical studies in both the US and internationally
• Clinical Operations/Development experience with a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
• Excellent understanding of the broad landscape of CROs and other vendors involved in conducting clinical studies
• Deep experience with negotiations, managing CROs, conflict resolution
• Excellent communication (oral and written) and presentation skills.
• 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

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.

Agios requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC) on or before their first day of work.  Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief, observance, or practice that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.