Associate Director, Development Business Operations, Vendor Outsourcing

Location
Foster City, CA, United States
Posted
Jul 04, 2021
Ref
2337325
Required Education
Bachelors Degree
Position Type
Full time
Associate Director, Development Business Operations, Vendor Outsourcing
United States - Remote

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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Note: This position can be located in: Foster City, CA or Morris Plains, NJ or Remote

Gilead Sciences is currently seeking an industry leader for Associate Director, R&D Outsourcing within our Development Business Operations department. The Associate Director will have the opportunity to provide category management, sourcing and contracting leadership in clinical outsourcing of global Phase 1b-Phase 3 clinical trials. The Associate Director will lead the entire life cycle including vendor selection, RFI, RFP, vendor selection decision, contracting, monitoring performance, change orders and ensuring proper closeout of clinical agreements, with a focus on Clinical Research Organizations (CRO). The position will have the opportunity to work in a matrix environment and regularly collaborate with Senior Management and cross functional teams.

The core responsibilities and skills required for this position include but is not limited to:

Key Responsibilities
  • Develops global clinical development vendor strategy
  • Advises team on RFP matters and removes roadblocks based on understanding of business requirements
  • Accountable for executing against the cost saving strategies at the category level (cost avoidance)
  • Develops and manages new standards supporting vendor governance that can apply across the portfolio for a category
  • Leads contract negotiation in partnership with functional leaders, and manages vendor relationships throughout the RFP process (e.g., MSA negotiations, amended MSAs)
  • Implements the inspection readiness strategy for the department (e.g., provides input for inspection preparation and responses)
  • Provides delivery excellence training and operational guidance to key internal and external stakeholders
  • Supports Category Review Processes within individual categories as a key group member and subject matter expert
  • Owns and maintains the departmental outsourcing standards which establish parameters for clinical outsourcing across the organization
  • Develops, leads and maintains departmental and cross functional policies and procedures
  • Responsible for developing departmental tools and driving continuous improvement
  • Assists with organizational strategy development and provides internal and external (vendor) training as necessary
  • Owns the departmental training plan to ensure internal and external stakeholders are unpdated on contract budgeting, development and administration
  • Proactively leads in process analysis/review with focus on improving efficiency and departmental harmonization


Leadership and Management
  • Provides leadership to senior managers and experienced employees
  • Is accountable for the performance and results of multiple related groups
  • Translates overall direction and strategy; communicates across organizational levels and departments
  • Manages operational functions including, supervising other staff who contribute to clinical contract management
  • Participates in establishing departmental and cross-functional policies and procedures
  • Impacts the business results of related teams by setting priorities, allocating resources, and developing policies and plans
  • Is accountable for the performance and results of a team
  • Interprets, executes and recommends modifications to operating policies and procedures
  • Adapts group plans and priorities to address resource and operational challenges
  • Accountable for developing talent through on-going performance feedback and career management coaching
  • Contributes to the development of new concepts, techniques, and standards; considered an "expert"
  • Accountable for building high-performing team by setting the right performance metrics and acquiring/retaining talent based on skill requirements
  • Lead a diverse and / or virtual team


Delivery Excellence
  • Develops global clinical development vendor strategy for a program or therapeutic area
  • Manages contract and sourcing activities for Phase 1b-3 clinical development programs providing consistent customer service and delivering quantitative value through cost savings and transformation/innovation
  • Develops and implements sourcing strategies to support given scope
  • Manages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings
  • Ensure the vendor selection process is compliant by managing risks through benchmarking, rate negotiations, implementing the sourcing strategy, collaborating with cross functional teams such as Compliance, Legal and Regulatory
  • Collaborates with internal customers in vendor bidding, specification gathering and proposal development (RFP creation and analysis)
  • Translates business requirements into vendor capabilities and develops recommendations for vendor selection for a program or therapeutic area
  • Leverages existing tools to benchmark costs and best practices
  • Is an SME in resolving complex issues relating to contract negotiation and management
  • Oversees the identification, selection and management of global external service providers
  • Leads Vendor bid defense meetings
  • Manages the contract negotiation process for complex or high value contracts
  • Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development


Strategic Thinking
  • Ability to understand, analyze and develop recommendations from multiple complex sources such as financial and operational perspectives
  • Influence vendor selection with stakeholders at the project team level


Innovation
  • Identifies, develops, and deploys best practices in vendor selection, cost containment, and category management practices
  • Leverages prior experience with external benchmarking, industry best practices, and technology for continuous improvement
  • Evaluates existing process and determines recommendations to improve cycle time, quality and increase overall value


Problem Solving
  • Develops solutions to a wide range of complex problems which require the regular use of ingenuity and innovation
  • Takes ownership of issues from problem identification to successful resolution, testing recommendations for reasonableness
  • Triages study-level vendor management issues; escalates high-risk issues to appropriate stakeholders
  • Translates trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up


Influence and Partnership
  • Engage with clinical operations leadership to drive sourcing strategy, compliance, and continued partnership
  • Exhibits competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance
  • Partners with internal stakeholders working on contracts in resolving complex issues relating to contract negotiation or management
  • Manages study level vendor relationships in conjunction with Clinical Operations


Decision Making
  • Delivers value by developing business solutions by translating requirements into effective sourcing solutions, contractual terms and process improvements
  • Demonstrated ability to make critical decisions related to clinical vendor agreement negotiations and escalations
  • Pulls data across functions according to business requirements and recommends global development vendors to senior leadership for endorsement for a project
  • Asks probing questions to uncover business needs and recommends solutions (e.g., negotiating timelines while maintaining standards)
  • Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols
  • Identifies operational and systematic issues, including frequency and escalates to the appropriate level


Communication
  • Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members
  • As necessary, trains internal stakeholders in contract budgeting, development, and administration


Capabilities and Requirements
  • Process harmonization / standardization
  • Talent management
  • Risk modelling
  • Experience in providing thought leadership and consistent customer service
  • Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and management
  • Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions
  • Demonstrated leadership skills while working in fast paced and changing environment
  • Financial acumen to review, analyze and understand cost drivers of complex budgets
  • Strong negotiations skills
  • Legal, clinical operations and regulatory acumen
  • Travel may be required

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Knowledge, Experience and Skills:
  • 10+ years of experience with a BA in a relevant discipline.8+ years of experience with a MS in a relevant discipline.
  • Relevant experience with a BA or MS in a relevant discipline
  • MBA or JD preferred
  • PMP/CPSM certification or equivalent a plus


For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans\' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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