Associate Director, Clinical Outsourcing (REMOTE)

Why Seres Therapeutics

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Position Summary

Reporting to the Vice President of Clinical Operations, the Associate Director will be jointly accountable for the identification, onboarding, oversight, and partnership of vendors supporting the Seres clinical studies. Individual will provide leadership in developing internal requirements associated with these services, and assure that strategic sourcing and relationship management best practices are employed throughout the project life cycle to assure best-in-class services are maintained. The AD will also participate in the development, negotiation, review and lifecycle management of global Phase I-III clinical vendor and related ancillary contracts and the management of 3rd party functional service providers/vendors involved in the contract management process.

What You'll Do

• Design and analyse KPIs in line with Seres' outsourcing strategy in order to drive continuous improvement


• Supports clinical operations with accruals tracking, budget development, and financial reporting tools, supporting VP with overall study budget oversight


• Acts as key partner to Clinical Trial Managers to execute successful vendor contracts and long-term partnerships as part of an outsourced service model; supports clinical study team in oversight of delegated responsibilities to vendors


• Supports clinical operations in execution of the oversight activities outlined in the Clinical Oversight Plan for CROs and other vendors


• In concert with legal and finance, negotiates directly with vendors for clinical trial services' optimal pricing


• Manages contract activities for multiple clinical development programs


• Jointly responsible for management of all global clinical development agreements (work orders, amendments, creation and management of purchase orders, confidentiality, ancillary and vendor master service agreements, single-service and subcontractor agreements)


• Identifies and manages contracts risks. Ensures appropriate mitigation plans are in place and in use and risks are communicated appropriately to stakeholders


• Provides information to stakeholders and management on contract statuses and contract/finance issues


• Responds and resolves complex issues associated with domestic and international contracts with support from the appropriate department(s)


• Assists staff working on contracts in resolving complex issues relating to contract negotiation or management


• Establishes and manages vendor relationships in conjunction with Clinical Operations, and other internal departments as required


• Establishes a robust performance management process and ensures vendor/supplier performance is understood and measured (eg cost control, simplification, best practice procurement)


• Ensures agreements comply with company requirements, regarding risk assessment and liability


• Partners with relevant staff to manage vendor/supplier bidding and proposal development (RFP creation and bid analysis). Coordinates and manages vendor bid defense meetings and associated follow up


• Leads contract life cycle management process related to vendor/supplier and collaborative agreements


• May also assess new vendors/technologies for use in our clinical studies and assess their capabilities with team(s) input to make sure we are staying current on trends/innovations in our clinical trials


• Develops and implements policies, procedures and standardized tools based on identified needs for standardizing SOW, bid grids, accruals, forecasting and invoicing


• Participates in function's budget development and periodic budgeting exercises for the organization

What You'll Bring

• BA/BS degree in business or related filed


• 6+ years clinical contract negotiation experience within pharma/biotech required


• Comprehensive experience with request for proposal process (RFP), evaluation/comparison of proposals, bid analysis and strong negotiation skills


• Mentoring/training experience a plus


• Strong understanding of regulatory and legal issues pertinent to clinical contracts


• Excellent analytical and customer service skill are essential

Candidates should be aware that Seres Therapeutics currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date.

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

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