Sr. Director, Clinical Outsourcing

Location
San Francisco, CA, United States
Posted
Sep 02, 2020
Ref
5232-814-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Sr. Director, Clinical Outsourcing to join their team.

Leads the Clinical Outsourcing function, including managing the team and process to identify, select, engage and manage third party vendors, clinical sites and investigators to execute clinical studies in compliance with Nektar's policy and procedures. Key responsibilities include: Development and ownership of sourcing through payment process for Nektar's clinical operations. Identification, selection, engagement and management of third-party vendors. Defining scope of outsourced services through facilitation of cross-functional requirement gathering and review & ensuring contracts align with internal expectations. Manage vendor performance against agreed upon expectations. Ensuring process and documentation is compliant with Nektar's policies and procedures. Developing and managing the clinical outsourcing team. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues, providing strategy and direction for major functional areas. Requires in-depth knowledge of the functional area, business strategies, and the company's goals. Leads the Clinical Outsourcing function, including managing the team and process to identify, select, engage and manage third party vendors, clinical sites and investigators to execute clinical studies in compliance with Nektar's policies and procedures.

Sourcing through Payment Process Ownership
  • Manage high volume of clinical contracting activities to ensure contracts are executed on time.
  • Develop and manage 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 development objectives.
  • Develops corporate and/or organizational policies and procedures and authorizes their implementation.
  • Collaborates with internal stakeholders (Clinical Operations, Legal, Finance) and third-party vendors on continuous improvement of processes and methodology for contracting with all clinical vendors.
  • Present contracts for executive signers and approvers, providing description of activities, key terms, negotiation strategy, alignment to program goals and budget, and other relevant interdependencies.
Identification, Selection, Engagement and Management of Vendors
  • Establish strategic collaborations and provider pool with qualified vendors and established relationships that will allow Company to realize shortened start-up time and cost savings.
  • Apply strategic sourcing methodology to assure attainment of best service and value.
  • Implement and coordinate strategic and effective provider relationship management and governance practices with external providers.
  • Develop sourcing strategies and methodologies to effectively manage vendors, support the oversight of transferred obligations, and ensure that clinical trial budgets are based on current operational assumptions.
  • Monitor vendor performance against agreed upon expectations.
  • Participate as a key strategic member of governance teams with CROs and other vendors, leading interactions to address issues and strengthen partnerships.
  • Facilitate cross-functional endorsement of selected vendors and scope Interact with other R&D leaders, relevant Project Team members, and Department Heads to ensure appropriate providers are identified and managed efficiently.
  • Ensure vendor selection process is documented to support GCP requirements.
Negotiation and Financial Management of Contracts
  • Ensures 3rd party outsourcing contracts & arrangements are aligned with internal requirements. Proactively manage and resolve issues that may impact program timelines with the development team.
  • Collaborates with Clinical Study team to define scope of services and align study assumptions to vendor contract scope.
  • Collaborates with Finance to align operational and budgetary study assumptions to identify out of budget activities & facilitate the correct approval process.
  • Manage high-level risks by making complex judgments, developing innovative solutions and applying a comprehensive cross-functional and industry understanding.
  • Works with Finance and Clinical Study team to develop and manage program operating budgets vs. actual.
Compliance with Nektar's Policies and Procedures
  • Maintain and optimize 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 (GCP standards, SOP's and Sarbanes-Oxley controls).
  • Ensure vendor selection documentation, third party vendor contracts, and fair market valuation documentation is filed for each study in compliance with company SOP's and GCP standards.
  • Communicate all third-party activities and contracts to Finance for all clinical studies to ensure complete and accurate clinical trial expense accruals.
  • Partner with Finance by providing 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 budget analyses used to improve future planning.
Management of Clinical Outsourcing Function
  • Establish and communicate strategic goals and objectives set for Clinical Outsourcing, including identification and monitoring of key performance indicators to allow identification of opportunities for continuous improvement.
  • Provide leadership and guidance to clinical study and clinical outsourcing teams to ensure they are operating as effective business partners to external service providers.
  • Provide direction to direct reports and clinical study teams to manage, in collaboration with Finance, a cradle-to-grave process/system for budget and contract planning and management.
  • Ensure a positive work environment focused on continuous improvement to meet the growing demands of the complex, global pipeline of clinical development activities.
  • Recruit, develop and supervise Clinical Outsourcing personnel to support the functions and objectives.
  • Provides regular performance feedback, development and coaching to direct reports.
Additional responsibilities
  • Consistently works on abstract problems across functional areas of the business.
  • Interacts internally and externally with executive level management and third parties, requiring negotiation of extremely critical matters.
  • Perform any other tasks as requested by Senior Management to support the organization's goals and objectives.
  • Through assessment of intangible variables, identifies and evaluates fundamental issues, providing strategy and direction for major functional areas.
  • Other duties as assigned.
Minimum Qualification Requirements
  • A minimum of a Bachelor's degree is required. An advanced degree, such as an MBA is preferred. Equivalent experience may be accepted.
  • A minimum of 15 years of experience in drug development business support including financial planning, contracts, and vendor management.
  • A minimum of 12 years of management experience.
  • Previous experience with increasing responsibilities in clinical outsourcing and operations required.
  • A solid understanding of clinical trial principles, design, and analysis.
  • Must have broad and deep understanding of contracts and outsourcing for Global Clinical Trials, including a basic understanding of legal, regulatory, GCP, and SOX, components of the process and understanding of clinical trial management principles
  • Must have experience in clinical operational planning in areas such as resource and budget forecasting, operational scenario planning and contract management, strategic agility and business acumen.
  • Excellent leadership, organizational and project management, communication, negotiation and influencing skills, contracting and legal knowledge/experience pertinent to geography, and experience with clinical research / clinical research organizations essential.
  • Strong influence and communication abilities across a diverse culture.
  • Ability to provide direction with cross-functional teams in highly matrixed team environment, interact with a wide variety of internal customers and relate effectively to people at all levels of the organization.
  • Requires in-depth knowledge of the functional area, business strategies, and the company's goals.
  • Must have a proven track record of successfully interacting with both internal and external executive levels.
  • Express strong leadership cross-enterprise to help advance Company's objectives.
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.