Associate Director, Clinical Outsourcing

Location
San Francisco, CA, United States
Posted
Sep 12, 2020
Ref
5239-814-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for an Associate Director, Clinical Outsourcing to join their procurement team.

Responsible for the identification, selection, contracting and fiscal management of third-party vendors, clinical sites and clinical study investigators required to conduct clinical studies in compliance with Nektar's policies and procedures. Collaborates with Clinical Trial Leads to ensure contracted services are aligned with operational requirements, clinical study assumptions and budgets and analyzes the budgeted costs to ensure Nektar is charged appropriately. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Work on complex problems or data that requires an in-depth evaluation of various factors. Establish and assure adherence to budgets, schedule, work plans, and performance requirements. Manage operational risks by making sound judgments, developing business solutions and applying a comprehensive cross-functional and industry understanding.

Sourcing through Payment Process
  • Implement strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
  • Manage and perform clinical contracting activities to ensure contracts are executed on time.
  • Assist in development and implementation of a Source-to-Pay process that provides consistency and visibility to the methods and strategies used to identify, select, manage, contract and analyze the financial and service provider resources utilized to achieve the R&D objectives.
  • Operate within a rigorous and consistent strategy, methodology, and tools (e.g., forms, templates, checklists, etc.) for provider identification, qualification, selection, management and relationship governance, ensuring adherence to global compliance expectations.
  • Collaborate with Legal, Finance and other internal stakeholders on continuous improvement of processes and methodology for contracting with all clinical vendors.
  • Evaluates and analyzes tools and processes to support outsourcing efforts.
Identification, Selection, Engagement and Management of Vendors:
  • Guide clinical study teams in the selection of qualified providers that complement Nektar Clinical Operations' strategic core competencies and allow the team to focus on internal operational excellence while relying on external providers for efficient and flexible execution of clinical trials.
  • Document selection process in compliance with Nektar policies and procedures.
  • Apply strategic sourcing methodology to assure attainment of best service and value and assuring vendor performance against agreed upon expectations.
  • Effectively manage vendor agreements, support the oversight of transferred obligations, and ensure that clinical trial budgets are based on current operational assumptions.
  • Monitor, control, and report performance metrics established for vendors.
Negotiation and Financial Management of Contracts
  • Analyze vendor or clinical site budgets to ensure costs are within expectations based on study assumptions and costs are reasonable in relation to value and services provided by vendor or clinical site.
  • Provide accurate and timely plans and forecasts for clinical trial cost estimates and budgets; ensuring efficient and compliant contracting of providers; validating of monthly expense accruals; and providing insightful analyses used to improve future planning.
  • Implement effective provider relationship management and governance practices, where appropriate, with external providers.
  • Interact with relevant Development Team members, and Functional Leaders to ensure appropriate providers are identified and managed efficiently.
  • Monitor, control, and report expenditures against established contracts and budget.
Compliance with Nektar's Policies and Procedures
  • Partner with colleagues in R&D to ensure the team is using consistent and efficient business processes and tools for outsourcing and vendor management that are compliant with GCP, SOPs, and corporate financial controls.
Additional Responsibilities
  • Sign documents for activities as authorized and described by company policies, procedures and job descriptions.
  • May mentor and develop junior clinical staff.
  • May manage full-time employees, temporary resources or consultant resources providing development, coaching and regular performance feedback.
  • Other duties as requested.
Education & Professional Experience:
  • A Bachelor's degree in clinical, biological or mathematical sciences or related field, or nursing qualification. A master's degree is preferred. Equivalent experience may be accepted.
  • A minimum of 8 years previous management experience is preferred.
  • Previous people management experience is preferred.
Industry Experience:
  • A minimum of 10 years or Pharmaceutical development experience with at least 4 years managing clinical trial vendors and/or clinical site contracting is required.
  • Experience and understanding of ICH, and GCP is required.
  • Solid understanding of clinical drug development processes is required.
Skills:
  • Must possess excellent project management skills.
  • Must have demonstrated problem solving abilities and strong organizational skills.
  • Excellent written and verbal communication skills are required.Must be a demonstrated self-starter and team player with strong interpersonal skills.
  • Must have effective problem-solving skills.
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.