Contracts Associate, Dev Sci Ops
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Development Sciences Business Operations (Business Operations) group is the center of excellence for providing industry best practice operational support for the conduct of BioMarin’s global clinical trials, including clinical vendor and site contract management, strategic vendor oversight, and clinical financial spend analysis and management. The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in clinical vendor and trial site spend, by managing the development, negotiation and execution of vendor and clinical site budgets and contracts, and managing the financial and resource projections across clinical projects and trials.
Key Responsibilities of Business Operations include:
- Aligning with Global Clinical Development on the clinical trial strategy in order to successfully contribute to trial execution;
- Portfolio and program-level vendor selection and contracting strategy, including negotiation of scope and budget for proposed vendor services in line with clinical trial assumptions, program drivers and milestones;
- Quantitative analysis of vendor bids and proposals;
- Drafting and negotiating vendor and clinical site contract and budget documents;
- Liaising with clinical development teams regarding all aspects of financial strategy and management;
- Supporting vendor contract management and performance oversight.
The Associate position is responsible for supporting a variety of activities within the Business Operations department including but not limited to supporting the execution of consulting agreements and non-disclosure agreements, the drafting and approval of vendor contracts, developing key contract templates and ensuring that new contracts and change orders are properly executed, and the development and implementation of functional projects focused on improving effectiveness or efficiency of processes.
Vendor Contract Management
- Facilitate the contracting process thru to execution of the entire contract, including all exhibits.
- Draft self-authored contracts and the QC of documents for non-self-authored contracts
- Update scope and/or budget, including business/payment terms
- Include any unique business terms to be added/negotiated
- Facilitate the review and approval of the contract including internal review, vendor review, vendor final negotiations within specified legal parameters, and escalation of any approval issues
- Ensure all contract types (MSAs, SOWs, COs, NDAs, consulting agreements and other assigned contracts) that originate in Development Sciences are efficiently managed through the Legal contract review and financial approval systems and entered into the department tracking system.
- Collaborate with Legal and other identified business areas, as appropriate, to ensure contracts are progressed on a timely basis
- Proactively communicate with key stakeholders on the status of contract review and approval
- Assist stakeholders with tracking of terms, PO funding, scope, and necessary changes
- Record all appropriate contract activities in department tracking system (BOARD)
- Partner with clinical service owners, Finance, Global Strategic Sourcing (GSS), Legal and Business Operations team member through the duration of the vendor contract to:
- Understand impact of identified changes on: study scope, vendor scope, budget and forecasts
- Understand accruals and forecast updates associated with contracted services
- Identify contract documentation requirements (e.g., CNF or CO) or whether a new category of services requiring a new vendor is required
- Request and receive Change Order proposals from vendor(s)
- Negotiate vendor scope/budget, including business/payment terms
- Communicate CO expectations to ensure all parties are made aware of any contract, budget and relationship impacts
- Prepare and speak to vendor contracting updates in study team meetings
- Resolve any contract execution, PO funding, and vendor payment issues as they arise
- Support contract close-out, as per department processes
- In collaboration with GSS, Sourcing Team or Functional Area, provide input to RFI/RFP content for bids, review proposals, and perform/present quantitative analysis for responses to RFP. Quantitative analysis to include:
- Comparison of budget with study assumptions
- Comparison of bids against previous contracts
- Comparison of bids against each other
- Attend and participate in bid defense meetings, as appropriate
- Leverage budget analyses and existing vendor performance data to inform selection
- Negotiate budget and scope with vendors, as appropriate
Site Contract Management Support
- Creation of NDAs including managing the process thru execution
- Assist Business Operations Program Site Managers:
- Draft Clinical Trial Agreement Amendments
- Request Clinical Trial Agreement (CTA) and CTA Amendment templates in internal contracts management system
- CTA total contract value records
- Track CTA and CTA Amendments negotiations in internal clinical trial management system
- Update and maintain site-specific record in internal clinical trial management system
- Customize site specific budgets based on master template
- Experience using Coupa/PO management systems and contract management systems (e.g., SpringCM, Ariba) is a benefit.
Education / Experience
- BA/BS in finance, accounting, legal, health sciences, or related degree. Experience in lieu of education is considered.
- 2 years of relevant experience working in the pharmaceutical industry or with CROs
- 1 year of relevant technical experience working with contracts and business operations
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.