Responsibilities may include, but are not limited to, the following:
Franchise accountabilities:
•Partner with key internal stakeholders (project leadership, clinical, medical affairs, commercial, finance, franchise head etc.) to understand the business and therapeutic area strategy for the franchise and the portfolio of assets to proactively plan, create and drive operational strategies for the assets under development for the TA or Franchise with an eye towards cost disciplined science.
Command of needs of the franchise and clinical operations and/or strategies to drive proactive and forward looking stakeholder management of key leadership within the franchise, project management and GCRDO.
•Provide strategic and clinical operational input to the franchise on business development and due diligence activities
•Represent study management at the development committees for the respective franchise to provide operational input and contribute to strategy for development of the assets.
•Ownership of the operational delivery and financial control for all clinical studies for assets in the franchise.
Program / Study Oversight
Oversee study management personnel to ensure timely delivery of high quality project deliverables across the portfolio within the franchise, including:
• Overall strategic management for the planning, execution and reporting of multiple clinical studies / programs (phase II –III) needed to support INDs, sNDAs, NDAs, MAAs
• Interact with Study Teams to ensure consistent performance and quality of work.
• Ability to work cross functionally as required to appropriately resource study teams.
• Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables.

Interact with other departments as well as cross-functional teams (i.e. Clinical Development Teams, Project Teams) to ensure timely delivery of high quality project deliverables, including:
• Represent Clinical Operations on assigned Clinical Development and Project Teams
• Identify and recommend solutions to problems and/or issues with personnel and/or processes across departments.
• Provide specific project / study support and operational input
• Work with associated department management in implementing processes to streamline the delivery of study requirements.

Therapeutic / Study Input / Guidance:
• Provide indication specific and operational guidance when needed
• Strategic consulting in relation to projects / studies
• Assess and evaluate studies / processes and support implementation and formulation of appropriate plans for action
• Participate in vendor selection and review process
• Identify new process opportunities, drive and support process improvement initiatives and work with appropriate personnel to implement and re-evaluate processes


Qualifications
Prerequisite:

BA/BS or equivalent degree in life sciences or allied health field
At least 15 years of experience in clinical operations roles, including at least 5 years of multi-national experience. Line management experience required

Skills/Knowledge Required:
 Experienced clinical R& D professional with knowledge of industry trends and experience in leading and driving operational programs and initiatives
 Line management skills and expertise / mentoring and coaching
 Disease / therapeutic knowledge (Immunology and inflammation)/ expertise highly desirable
 Excellence in understanding of business and commercial strategy
 Excellence in financial forecasting and budgeting skills & resourcing skills
 Excellent oral / written / presentation – communications skills
 Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process
 Leadership skills / negotiation skills
 Effective teamwork and teambuilding skills transferable across functional levels
 Time management - ability to effectively multi-task and prioritize in matrix environment
 Cross functional and cross-cultural awareness

Key Competencies:
• Show Drive & Initiative: Establishes aggressive goals and drives for results; readily puts in extra time and effort; tackles problems and works to resolve them without delay; establishes high standards of performance
• Show Adaptability: Responds resourcefully to new demands and challenges; works effectively in ambiguous situations; adapts behavior in response to feedback and experience; deals constructively with own failures and mistakes
• Foster Open Communication: Keeps people up-to-date with information; listens attentively and with empathy to concerns expressed by others; encourages others to express their views, even contrary ones; speaks clearly and concisely.
• Make Sound Decisions: Makes timely decisions based on accurate logic; looks beyond symptoms to identify causes of problems; makes decisions in the face of uncertainty; takes all important issues into account when making decisions.
• Act Strategically: Balances big-picture concerns with day-to-day activities; stays informed about industry practices and new developments; understands the organization’s mission and strategies.
• Develop Others: Attracts high caliber talent; gives clear, motivating and constructive feedback; provides challenging assignments to facilitate individual development; willingly shares expertise and experience with others.
• Planning: Develops short and long-range plans that are appropriately comprehensive, realistic and effective in meeting goals; integrates planning efforts across work units.
• Displays Organizational Savvy: Develops effective give and take relationships with others; understands the agenda and perspectives of others; recognizes and effectively balances the interest and needs of one’s own group with those of the broader organization.
• Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality.
• Recognizes Global Implications: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one’s own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches.
• Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.
• Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new of modified approaches; brings perspectives and approaches together combining them in creative ways.
• Leadership: Exemplary leadership/influence management skills with ability to foster partnerships in the matrix organization across functions and geographies. Ability to balance multiple and often conflicting priorities and making difficult decisions. Experience in leading change in a dynamic fast paced environment.