• Drives operational strategy and planning for assigned portfolio of work across BMS and/or non-BMS programs.

• Provides oversight of all clinical studies within assigned portfolio, via effective matrix management.

• Represents the GDO Strategy organization as a participating member of the Development and/or Medical Teams.

• Participates and provides input to the vendor selection and review process.

• Participates in the program/portfolio reviews with CRO partners, as applicable.

• Strategically assesses study/program metrics and ensures implementation of appropriate measures to support project or program targets/deliverables.

Position Responsibilities:

Study Planning and Conduct:

• Drives business strategy from an operational perspective.

• Accountable for study execution, within established timelines, budget and quality parameters.

• Acts as primary escalation point for all operational issues.

• Participates in necessary governing forums.

• Identifies improvement opportunities and brings forward best practices to support study execution within the portfolio, and across the broader organization.

• Proactively partners with cross functional counterparts and external vendors to address issues/concerns.

• Accountable for financial stewardship of programs, while working in close partnership with Finance.

Operational Leadership / Decision Making:

• Drives and/or develops project standards and ensures consistency and efficiency across the studies within the program.

• Consistently makes operational decisions in a timely manner.

• Uses expert judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities.

• Acts decisively to address study team challenges.

• Proactively identifies and manages risks and issue escalation across the assigned portfolio.

• Flags potential process improvement opportunities and support execution.

Communications

• Builds effective partnerships across functional area leadership.

• Drives issues to resolution and communicates to ensure that issues have been worked through to completion.

• Applies change management principles to support communication and implementation of integrated change.

• Frequently communicates program status to different levels of stakeholders, including Sr. Leadership.

Requirements:

• Minimum 8 years of global experience in clinical drug development or other related experience.

• Experience in Neurology TA required

• Broad clinical operational experience (registration and/or post-approval is a plus).

• BA/BS or equivalent degree in relevant discipline

• Strong knowledge of GCP/ICH, drug development process, and other relevant guidelines for clinical research activities.

• Experience leading global clinical research activities.

• Therapeutic Area knowledge.

• Proficient project management skills.

• Strong presentation skills.

• Financial acumen.

• Effective oral and written communication skills to influence, inform and guide a global operational team.

• Consistently demonstrates positive attitude about the team’s ability to deal with challenges.

• Strategic Thinking: Formulates objectives and priorities and implements plans consistent with the long-term interest of the organization in a global environment, capitalizes on opportunities and manages risks.

• Enterprise Mindset: The ability to make decisions, set priorities and share resources based on what will benefit the whole organization. Capable of building and maintaining networks within and outside of the organization to both strengthen the understanding of the big picture and leverage diverse perspectives, experiences and expertise to maximize performance.

• Change Agility: Capable of constantly thinking ahead and scanning the environment for opportunities. The ability to navigate ambiguity for themselves by demonstrating smart risk taking and personal resilience. Lead others through change by continuously creating the context and engaging individuals.

• Authentic Leadership: Capable of building legitimacy through cultivating honest relationships. Ability to generate trust by demonstrating the highest level of consistency between their words and their actions and maintaining integrity, especially under pressure. They are role models and promote an environment of openness.

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