Clinical Outsourcing Lead - La Jolla, CA | Biospace
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Clinical Outsourcing Lead

Pfizer Inc.

La Jolla, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description


  • Works independently to negotiate contractual budgets, business terms and the scopes of service with CRO's and other service providers
  • Ensures the protection of Pfizer's clinical outsourcing business interests. Accountable to minimize Pfizer's business risk and maximize research dollars in each contract.
  • Provide expert contracts and outsourcing guidance to internal and external stakeholders
  • Acts as a central point of contact for business-related issues and facilitates contractual/financial conflict resolution.
  • Leads study, program, and asset level outsourcing efforts. Provides situational outsourcing consultation and guidance, as required.
  • Provides support and/or oversight for key areas within Sourcing Operations (i.e. PSC Development, FCPA Process, etc.).
  • Embrace and drive forward the current outsourcing model with CRO and other Preferred Providers.


  • Works independently on most assignments using knowledge and work experience in outsourcing to achieve desired results at a high rate of accomplishment.
  • Liaises frequently with stakeholders to ensure they understand and have realistic expectations of Sourcing Operations contracting process, systems, compliance requirements and contracting cycle times.
  • Partners with Sourcing & Vendor Management colleagues and study teams to identify and evaluate available outsourcing and resourcing options to support decision-making relative to clinical trial execution at a global and local level.
  • Understands and utilizes cloud-based tool (COST) to effectively and efficiently support CRO competitive bids, bid analysis, budget negotiations, lifecycle management (e.g. change requests/change orders) and reporting.
  • Manages the outsourcing process as an agent of Sourcing Operations:
    • In collaboration with study teams, gains an in-depth understanding of study requirements in order to secure appropriate level and type of resources and services from Contract Research Organizations (CROs) and other service providers
    • identifies and brokers appropriate outsourced study execution options
    • requests competitive bids/proposals from CRO Preferred Providers & other technical service providers
    • independently pressure tests and analyzes complex budget proposals and provides recommendations and analysis to study teams for decision making
    • facilitates the vendor selection process in collaboration with study teams and Sourcing & Vendor Management
    • negotiates budgets with vendors and challenges costs when not appropriate. Proactively escalates issues that may become contentious to line management.
  • Responsible for the preparation of Request for Proposals and bid analyses.
  • Responsible for the preparation, negotiation and finalization/execution of full-service CRO Preferred Provider Work Orders, Vendor Services Agreements, Change Orders, Consultant Agreements, Master Services Agreements and other types of ad-hoc agreements.
  • 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
  • Designs creative and risk-averse payment schedules in order to drive vendor performance, protect Pfizer's financial interests and complies with vendor-specific MSA terms as well as Sarbanes-Oxley, Generally Accepted Accounting Principles and other regulations.
  • Oversees Per Subject Cost (PSC) development process and supports the PSC escalation process.
  • Oversees and/or supports the development, negotiation and execution of Clinical Study Agreements (CSAs), as required.
  • Communicates impact of significant scope changes and associated budget to BUs/RUs and other stakeholders proactively to ensure funding availability.
  • Provides oversight and leadership as a subject matter expert within Sourcing Operations in one or more key areas (e.g. COST, SOX Compliance, etc.).
  • Lead or participate in special projects and/or initiatives to help achieve business objectives.
  • Actively supports Pfizer's OWN IT culture.
  • Applies extensive working knowledge and subject matter expertise to identify and advance business improvements with processes, systems, etc. Works with Sourcing Operations Group Lead to drive the creation and implementation of best practices.
  • Actively participates in Portfolio Review Meeting. Clearly present and articulate any business, contractual and/or financial risks related to assigned assets to Leadership team.



  • BA or BS degree and/or recognized amount of work experience in a related discipline.
  • Clinical trials Sponsor experience, CRO operational and/or proposal development experience, or other trial related experience, including significant experience negotiating and drafting clinical trial-related agreements is required.
  • Excellent oral/written communication skills and proficiency with MS Office applications (Word/PPT/Excel) is required.
  • Experience with Ariba Contract Workbench, ClearTrial, SalesForce, Grants Manager and / or other industry cost and planning tools is desired.
  • Finance/Clinical Budgeting Experience
    • Demonstrate clear understanding of clinical trial-related costing
    • Understands components of per subject costing & use of industry benchmarking
  • Operational knowledge of clinical trial study execution activities (e.g. study start-up, maintenance and closeout activities)
  • Knowledge of clinical trial outsourcing
  • Understanding of the operational impact of proposed scope changes to study timelines, budget, and performance.
  • Knowledge and experience of negotiating and contracting with CROs and/or other technical service providers
  • Demonstrated ability to apply Enterprise-level contracting and outsourcing strategies
  • Demonstrated internal and external influencing skills for expectation and timeline management


Some travel required (approximately 5-10 business days per year)


Not eligible for relocation benefits

Eligible for employee referral bonus

Posting Expiration Date: August 23, 2017

Grade 12

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.