Sr. Clinical Outsourcing Manager

Location
San Francisco, CA, United States
Posted
May 04, 2018
Ref
3252-520-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

Responsible for outsourcing and contracting services provided throughout Drug Development. Provides direction, oversight and expertise to the organization in order to bring operational excellence to the business planning and financial management of clinical trials; and to the identification, selection and management of global external service providers. Oversees and maintains the relationship with contract research organizations. Evaluates and analyzes tools and processes to support outsourcing efforts. Contracts investigators for studies and ensures compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature. Typically travels to field sites to supervise and coordinate clinical studies, by monitoring schedules and clinical evaluation projects. Selects, develops and evaluates personnel to ensure the efficient operation of the function. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques. Manage operational risks by making sound judgments, developing business solutions and applying a comprehensive cross-functional and industry understanding.
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. 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. 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. Collaborate with Legal, Finance and other internal stakeholders on continuous improvement of processes and methodology for contracting with all clinical vendors.
Guide clinical development teams in the selection of qualified providers that complement Drug Development's 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.
Apply strategic sourcing methodology to assure attainment of best service and value, and assuring vendor performance against agreed upon expectations. Implement effective provider relationship management and governance practices, where appropriate, with external providers. 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. Effectively manage vendor agreements, support the oversight of transferred obligations, and ensure that clinical trial budgets are based on current operational assumptions. Interact with relevant Development Team members, and Functional Leaders to ensure appropriate providers are identified and managed efficiently. Perform any other tasks as requested by Senior Management to support Drug Development goals and project objectives. Monitor, control, and report expenditures against established contracts and budget. Monitor, control, and report performance metrics established for vendors.
Sign documents for activities as authorized and described by company policies, procedures and job descriptions. May mentor and develop junior clinical staff.

Requirements:

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 9 years Pharmaceutical development experience with at least 5 years managing CROs is required. A minimum of 5 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred. Previous people management experience is preferred. 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.