Senior Manager, Business Strategy & Operations

Job Description

The Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients.

The Business Strategy & Operations team within the CTC organization is responsible for driving strategic and operational process improvements and/or implementation of processes for Clinical Operations. The Sr. Manager, Business Strategy & Operations role supports and manages new workstreams and initiatives for the Clinical Operations organization within a fast-paced and highly regulated environment. In addition, they will have multi-project responsibilities and serve as a project manager as needed on complex initiatives and working groups.

Job Description:

• Serving as Project Manager, drives assigned initiatives/projects and working groups ensuring progression to achieve timelines
• Working as an execution implementation lead, ensure completed initiatives are adopted and embedded as ClinOps ways of working (office hours, working with learning and development to create/implement training, etc)
• Allocation to new/existing ClinOps and non-ClinOps led workstream/initiative to provide input and drive key processes from a ClinOps perspective
• Reporting on study CRO/Vendor sourcing strategy and headcount resourcing
• Reviews and recommends changes to Clinical Operations process management/improvement and associated procedural documentation in collaboration with business process owners, cross-functional stakeholders, and subject matter experts
• In collaboration with other CTC sub-functions, provides direction to study teams, business process owners, cross-functional stakeholders, and subject matter experts on initiative recommendations
• Drives standardization and the adoption of best practices across the Clinical Operations organization

Required Knowledge/Skills:

Project Management Fundamentals

• Navigate projects amidst ambiguous situations and changing priorities
• Manage multiple projects while monitoring quality work product from self and team
• Align stakeholders, manage project scope, and drive teams to achieving timelines
• Collaborate with key stakeholders to define project objectives, scope, and deliverables for process optimization initiatives.
• Influence leaders from multiple disciplines through a project plan by providing guidance, mentorship, and support to ensure successful project execution
• Implement project/process improvement methodologies such as Lean Six Sigma to drive continuous improvement across the organization (desired, but not required)

Core Technical Skills

• Analyzes problems and logically structure problem-solving strategies to resolve identified/anticipated issues
• Thorough knowledge of FDA, EMA, and other applicable national regulations, such as ICH guidelines and GCP
• Fluency with Microsoft Office suite
• Strong interpersonal and negotiation skills
• Synthesize inputs from various stakeholders into coherent deliverables and outputs

Interpersonal Skills

• Strong change champion with a good understanding of change management strategies
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives
• Demonstrate strategic enterprise thinking to find innovative ways to increase process efficiency
• Supports the organization and key stakeholders on a change journey with discipline, transparency and authenticity

Education & Experience

• 6+ years of relevant experience (Clinical Operations/project management, process improvement) with Bachelor's degree
• 4+ years of relevant experience (Clinical Operations/project management, process improvement) with Master's degree
• Experience working with one or more therapeutic areas (and managing clinical trials) in varying stages of drug development is a strong preference