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Senior Manager, Clinical Vendor Contracts & Alliance Management, Clinical Operations

$110k - $165k

Agios

Manager/Senior Manager, Clinical Vendor Contracts & Alliance Management, Clinical Operations Agios Pharmaceuticals is searching for a Manager/ Senior Manager, Clinical Vendor Contracts and Alliance Management, to join our growing Clinical Business Operations team, part of the larger Clinical Operations group. The (Sr.) Clinical Vendor Contracts Manager 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. Leveraging vendor knowledge and experience, individual will lead vendor selection activities through collaboration with Clinical Operations and the larger study team. Includes, but is not limited to contributing to service needs discussions in Clinical Trial Working Group (CTWG), identifying vendors, gathering business needs, and leading RFPs, bid defense meetings, scoring and award discussions. Lead contract reviews, negotiate terms, budgets, and payment schedules. Manage contracting activities including preparation, finalization, and administration of CDAs, Work Orders, Change Orders, and Amendments for assigned studies and/or program(s). Facilitate study kickoff meeting preparation and participate in kickoffs 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, and plans are discussed and implemented when expectations are not met. Monitor the outsourcing environment to keep current of providers and industry trends and suggest new vendors and/or services where opportunities arise and strategy aligns. (Sr.) Identify, lead, and participate in Clinical Business Operations and other Clinical Operations process improvement projects. Collaborate with QA and compliance to ensure quality management of vendors. Initiate qualification requests, participation in qualification kick off meetings, and participation in follow‑up meetings and mitigation discussions where needed. (Sr.) Work with QA and compliance on quality issue management activities including participation in meetings and ownership of applicable actions. Management and oversight of study budgets for assigned studies including: Creating and 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

  • Sr.) Contribute to annual budget review and Long‑Range Planning (LRP) discussions.
  • Sr.) Mentor and/or manage junior team members.
Bachelor's degree required. MBA or advanced degree preferred. At least five (5) years’ for Manager / eight (8) years’ for Sr. Manager 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.
  • Sr.) At least two (2) years’ experience mentoring and/or managing team.
  • Sr.) Working knowledge and understanding of clinical trials budgeting software.
Experience and proven proficiency with study budget and project management. Excellent understanding of the broad landscape of vendors involved in successful delivery of clinical studies. 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. 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 of 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. Competitive and equitable performance‑based compensation. This includes base salary and both short‑ and long‑term incentives that are connected to our business strategy and vary based on individual and company performance. The current base salary range for this position at the Manager is expected to be between $110,000 and $165,000 annualized and the current base salary range for this position at the Senior Manager is expected to be between $131,000 and $196,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. #J-18808-Ljbffr Agios

Vacancy posted 13 hours ago
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