Opportunity Details

Job Summary

• General resource for internal and external stakeholders regarding the approach to Clinical Development & Operations and other areas of Research & Development in support of flexible resourcing and sourcing strategies, and contract management, and applicable Sponsor policies and procedures.
• Helps ensure the protection of Sponsor's business interests. Accountable for minimizing Sponsor's business risk and maximize research dollars in each contract. Acts as a central point of contact for business-related issues and facilitates contractual/financial conflict resolution.
• Manages sourcing and contracting efforts for assigned areas of support (study and/or functional level). Provides situational contracting consultation and guidance, as required, and collaborates with other BVSM Functions, Procurement, Finance, Legal when appropriate.
• Implements current established sourcing and contracting strategies on an engagement-by-engagement basis.
• Creates business terms and the scopes of service with all types of service providers, for medium complexity engagements.

Job Responsibilities

• Responsible for the independent preparation, commercial terms & conditions review, and finalization of medium complexity contract execution by conducting final review to ensure accuracy and completeness as well as coordinating and obtaining all necessary signatures of assigned non-MSA agreements across BVSM-assigned groups.
• Works on most/all assignments using knowledge and work experience in contracting to achieve desired results at a high rate of accomplishment.
• Liaises frequently with stakeholders to ensure they understand and have realistic expectations of contracting process and systems.
• Partners with internal customers to identify and evaluate available sourcing and contracting options to support decision making relative to service/resourcing need at a global and local level.
• Directly negotiates proposed changes to standard contract language within guidelines provided by the Legal Division; escalates requested changes that fall outside of guidelines to the Legal Division and other stakeholders, as required
• Participates in special projects and/or initiatives to help achieve business objectives. Ensures compliances with BVSM Compliance & Business requirements

Qualifications:

• BA or BS degree and recognized amount of work experience in a related discipline.
• 5 years of Sponsor experience, CRO operational and/or proposal development/contract management experience, or other related experience, including significant experience negotiating and drafting vendor agreements is required.
• General knowledge of all phases of drug development (pre-clinical, phase I-IV, post-marketing/approval activities)
• Finance/Clinical Budgeting Experience
• Demonstrate clear understanding of clinical trial and related functional/service area costing
• Demonstrate clear understanding of various contracting and budget models
• Knowledge of clinical trial study execution and related functional/service area activities (e.g. study start-up, maintenance and closeout activities)
• Understanding of the operational impact of proposed scope changes to study/project timelines, budget, and performance.
• Knowledge and experience of negotiating and contracting with CROs and/or other technical service providers