General Scope and Summary
This position provides overall leadership, management and guidance for Global Clinical Outsourcing across Development. Ensures internal alignment on principles and approaches to management, oversight and governance of vendors contracted to deliver program and study level clinical trials. Establishes, manages and leads Global Clinical Outsourcing function; develops and implements policies and procedures as well as tracking and reporting up to Senior Management.
Roles and Responsibilities
- Establish the Global Clinical Outsourcing function at Sage
- Create global outsourcing strategies and ensure alignment and implementation
- Define the global vendor selection process and developing appropriate tools and guidance documents to support the study teams
- Ensure compliance with vendor selection process throughout life of study
- Work with the individual study teams to create appropriate proposals and drive the RFP process for outsourced work
- Define the vendor management, oversight and governance process (as applicable) including requirements for documentation, analysis and performance trends across individual functions and across multiple projects/programs
- Organize bid selection, defense and decision making within Sage
- Focus on performance management and delivery of contracted work by vendor and across vendors (as applicable)
- Review, ensure cross functional alignment and propose prioritization of any outsourcing process improvement projects
- Establish benchmark metrics and performance improvement initiatives
- Identify and establish any essential committees to ensure vendor management is approached consistently across the Development organization
- Collaborate with QA and compliance to ensure quality management of vendors
- Collaborate and ensure alignment with key stakeholders across the organization with responsibilities impacting vendor management
- Provide leadership, management and guidance to direct reports.
- Recruit and hire staff and contractors as needed; conduct performance management, career development, compensation planning
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, and resourceful. This leadership position requires enhanced change management skills and the ability to guide appropriate strategic discussions across the organization.
- 12+ years experience in clinical research and development
- Extensive experience with cross functional operational and business management
- Extensive experience with vendor management best practices
- Track record of establishing effective business relationships with internal and external customers
- Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe
- Excellent written and verbal communication skills
- Excellent project management, leadership, communication, management and organizational skills, as well as a high level of proficiency with problem solving, conflict resolution, negotiation and team building skills
- Flexibility to adapt to the dynamic needs of a growing biotech company
- Willingness to embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of SAGE.
- Bachelor’s degree required. Advanced degree preferred (MS/MA/MBA)