Description
As a Sr. Manager, Outsourcing and Vendor Governance team member, you will be responsible for managing outsourcing needs for current and future Phase I to IV clinical trials, including vendor identification, RFPs, vendor selection, contract and budget negotiations, budget management, audit readiness, and supporting the vendor governance process. You will work closely with the Clinical Operations study team, Legal, Finance, and other key internal stakeholders to resolve vendor contract and business-related issues. This role will report to an Associate Director in Outsourcing and Vendor Governance.
Responsibilities:
- Manages the clinical outsourcing activities with CROs and other ancillary clinical service providers.
- Independently manage all outsourcing activities including (but not limited to) - supplier assessment, RFP/RFQ/RFI, selection, contract budget, payment schedule, payment terms & scope negotiation through to contract execution and contract life cycle management.
- Manage global clinical development agreements (work orders, amendments, CDAs/NDAs, ancillary, single-service, HCP agreements, and subcontractor agreements).
- Negotiate new and amended work specifications, budgets, payment schedules, payment terms, ensure service providers adhere to contract terms and conditions.
- Guide project teams through the sourcing process and give appropriate suggestions and advice on the best approach/industry best practices.
- Partners with study team members to manage supplier bidding and proposal development (RFP creation and bid analysis). Facilitates and manages supplier bid defense meetings and associated follow-up.
- Leads contract related communication with suppliers. Respond to questions from internal stakeholders. Interact with suppliers on standard contract terms. Appropriately escalates issues and conflicts.
- Demonstrate expanded understanding of procurement/strategic sourcing principles and supplier selection criteria.
- Demonstrate expanded understanding of legal language to lead contract review and negotiation.
- Identify and manage contract risks. Ensures appropriate mitigation plans are in place and communicate risks to stakeholders.
- Provide information to stakeholders and management on contract statuses and contract/finance issues.
- Ensure agreements comply with company requirements regarding risk assessment and liability.
- Responds and resolves complex issues associated with contracts with support from the appropriate department(s).
- Establishes and manages supplier relationships in conjunction with Clinical Development functions, and other internal departments, as required, including participation in financial health meetings.
- Develop and manage tools to analyze changes between contract versions and change orders.
- Measures and reports service provider outsourcing task-related performance using metrics and KPIs to ensure compliance against agreed upon expectations such as timelines, cost, and quality (e.g., cycle time between joint review meeting and delivery of bid).
- Assist/Lead in the development, improvement, and implementation of processes and tools related to outsourcing activities.
- Support internal and external outsourcing process training.
- Support audit-readiness efforts.
- Use outsourcing systems in compliance with expectations and enter data in a timely manner.
- Manage purchase order process in support of Clinical Development stakeholders and functions.
- Support and manage general and ad-hoc projects as required.
- May be responsible for administrative tasks in support of new vendor onboarding.
- Direct supervision and/or provide mentorship and guidance to colleagues within the function/department.
Qualifications:
- B.A./ B.S. is highly preferred.
- At least 8+ years equivalent related business/ industry experience.
- Experience in pharmaceutical, biotech, academia, CROs (Clinical Research Organizations).
- Experience in Life Science, Finance, Strategic Sourcing, and/or Business Strategy.
- Solid understanding of drug development process including outsourcing for Phase I to IV clinical trials in a global setting.
- Experience in RFP development, proposal evaluation, and contract and budget management.
- Must be an initiative-taker with minimal supervision.
- Exhibit high self-motivation and ability to work and plan independently as well as in a team environment (virtual or in person).
- Work with cross-functional team members and facilitate communication with internal/external stakeholders.
- Excellent organizational and time management skills to accomplish multiple tasks efficiently and effectively in a demanding environment.
- Diligent and detail-focused with ability to expedite quick turn-around.
- Critical thinking, analyze and synthesize information to understand issues, identify alternate options, and support sound decision making.
- Excellent computer skills including advanced knowledge in use of MS Excel, Word, PowerPoint, and Outlook.
- Strong verbal and written communication skills.
- Execute time-sensitive matters while maintaining accuracy and confidentiality.
- High degree of professionalism, punctuality, deliver commitments on-time, understanding of the culture, and positive interactions with others.
- Display sound business judgement.
- Exercise independent judgement in methods, techniques, and evaluation of criteria for obtaining results.
- Ability to travel, including overnight stays.
Physical Requirements: Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $165,000- $182,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
EOE
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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