Associate Director, Clinical Outsourcing (Clinical Site Contracting & Budgeting)

Location
San Francisco, CA, United States
Posted
Jan 08, 2021
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 (Site Contracting & Budgeting) to join their procurement team.

Nektar has an exciting opportunity for an Associate Director, Clinical Outsourcing (Site Contracting & Budgeting) to join their procurement team.

Description:

Responsible for the contracting, budgeting, assessment of Fair Market Value (FMV), and fiscal management of 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 clinical study assumptions and budgets are accurate and analyzes the budgeted costs to ensure Nektar is compliant with FMV and health care professional policies and regulations. 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.

Contract 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.
  • Operate within a rigorous and consistent strategy, methodology, and tools (e.g., forms, templates, checklists, etc.) for clinical site contracting, 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 sites.
  • Evaluates and analyzes tools and processes to support clinical site contracting efforts.
Negotiation and Financial Management of Contracts:
  • Analyze 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 clinical site.
  • Provide accurate and timely plans and forecasts for clinical trial cost estimates and budgets; ensuring efficient and compliant contracting of clinical sitess; validating of monthly expense accruals; and providing insightful analyses used to improve future planning.
  • Monitor, control, and report expenditures against established contracts and budget.
Identification, Selection, Engagement and Management of Vendors:
  • May assist in the identification, selection, engagement and management of some vendors related to clinical site engagements.
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 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 site contracting is required.
  • Experience and understanding of ICH, and GCP is required.
  • Solid understanding of clinical drug development processes is required.
Skills:
  • Must have demonstrated problem solving abilities and strong organizational skills.
  • Must possess excellent project management 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.