Benjamin G.

Build and lead the Clinical Outsourcing strategy and manage the Clinical Contracting function, with responsibility for clinical development supplier management, process development and improvement, and management of clinical budgeting and forecasting

Oversee the strategy for implementation as well as the execution of all clinical trials at SQZ . Responsible for leading all operational aspects of SQZ’s clinical trials from study concept through report writing and support of regulatory submissions. Lead strategic study planning to enable success in clinical programs; inclusive of site selection and start-up, core functional oversight of data management, medical writing, PVG, site monitoring, as well as support the review and submission of regulatory filings. In addition to oversight of Clinical Operations, and in collaborating with key stakeholders, lead supplier strategies and selection aligned with business objectives. Supporting a growing pipeline portfolio, leads cross-functional teams through all aspects of strategic sourcing in Clinical Development, delivering high quality, cost effective business results. Leads and executes the sourcing process including, but not limited to, preparing and issuing RFIs/RFPs, analyzing supplier responses, facilitating the supplier evaluation and selection process, negotiating agreements for outsourced activities with clear and comprehensive scope of work and competitive pricing. Manages key supplier relationships and conducts supplier governance meetings to achieve outsourcing excellence. Leads financial planning process for responsible functions and long range plan. Fosters an environment of continuous improvement through effective team management and collaboration with stakeholders and external service providers.

Develop supplier strategies and establishes a sustainable supplier network aligned with business objectives. Directs the continuous development and maintenance of procurement systems and tools. Supporting a growing pipeline portfolio, leads cross-functional teams through all aspects of strategic sourcing in Early Discovery Research, Pre-Clinical, Clinical Development, delivering high quality, cost effective business results. Leads and executes the sourcing process including, but not limited to, preparing and issuing RFIs/RFPs, analyzing supplier responses, facilitating the supplier evaluation and selection process, negotiating agreements for outsourced activities with clear and comprehensive scope of work and competitive pricing. Manages key supplier relationships and conducts supplier governance meetings to achieve outsourcing excellence. Fosters an environment of continuous improvement through effective team management and collaboration with stakeholders and external service providers.

Partnering with the Clinical Operations, Legal and Finance teams to lead outsourcing, contract negotiations, and vendor management of vendor/site agreements; as well as lead the financial planning process for responsible functions. Manage outsourcing of development and related tasks in cooperation with project teams throughout the lifecycle of a project. Lead financial planning process for responsible functions (budget, forecast, long range plan) in order to provide forward-looking direction, to develop key scenarios, and to identify key risks/uncertainties and plans for potential mitigation. Facilitate the process of vendor selection for the Clinical Organization, as required. Propose potential vendors, ensure that Contract Owner/Teams clearly define the work specifications required from the vendor and develop requests for proposal (RFPs). Create proposal comparison documents to facilitate Curis’ analysis and critique of vendor proposals and result in optimal vendor selection. Negotiate contract terms and conditions in collaboration with the Legal Department, functional teams, and vendors. Ensure that the scope of work is clear and comprehensive. Negotiate costs with the vendor and ensure that pricing is reasonable and justified. Develop and ensure that contract payment schedules financially protect the company and promote work progress. Partner with Director, Clinical Operations and CROs/applicable vendors to ensure that study conduct is on track and quality/timeline metrics are met. This person will work to actively address or escalate (per quality standards) issues as they arise. Lead efforts to benchmark industry best practices. Ensure alignment/integration with CRO partners, including development and oversight of key performance and quality indicators. Develop, lead and implement strategic initiatives to simplify and improve the contract administration process.

Provide outsourcing coordination (Contract Management), communication and escalation support (Vendor Management) and financial management support for current and planned clinical studies and related activities. Coordinate all outsourcing activities under the supervision of Senior Director, Clinical Outsourcing. Apply complete understanding and application of industry principles, concepts, practices and standards. Provide regular communication with respective area management, review of interdependent timelines and financial requirements and providing strategic recommendations (solutions) to the teams.

As a Contracts Analyst at Shire; I manage, negotiate, review, interpret and process various agreements for commercial industry research. I am responsible for internal and external vendor and project management, and collaboration amongst different divisions and departments within Shire in order to advance clinical programs. I also oversee different sourcing events and initiatives over multiple categories.

When working for the Beth Israel Deaconess Medical Center a Harvard-affiliated teaching hospital, I was responsible for reading, negotiating and drafting 1/2 of the hospitals sponsored clinical trials. Coming from a business development background, I am knowledgeable in many aspects of the pharmaceutical/biotechnology/drug industry with experience in intellectual property, commercial partnerships, licensing and research.

Working closely with the Deputy Director of Business Development, I identified and researched future partnerships for MBL. I was also in charge of overseeing and revising outgoing and incoming business contracts, in the areas of research, licensing, confidentiality and clinical trials.