Responsibilities:
- Partner across Development study teams and cross-functional partners to drive strategic operational planning (approaches, assumptions, timelines, risk management, delivery frameworks).
- Develop portfolio-level tracking mechanisms, dashboards, KPIs, and performance analytics for transparency and data-driven decisions.
- Drive prioritization and scenario planning across TA/s to align to the critical path and deploy resources effectively.
- Represent the portfolio in leadership and governance forums to ensure continuity, alignment, and clear decision pathways.
- Develop and continuously refine best practices, operating models, playbooks, and standards to reinforce planning rigor and predictable execution.
- Ensure operational plans are documented, actively managed, and responsive to risks, external changes, and portfolio dependencies.
- Collaborate to support operational readiness, including inspection readiness, vendor oversight frameworks, and compliance.
- Establish/evolve operating rhythms and governance structures to streamline communication and enable timely decisions.
- Serve as a strategic thought partner to challenge assumptions, integrate lessons learned, and drive continuous improvement.
- Partner with CROs and external vendors to ensure proactive execution, scope adherence, and high-quality delivery; establish oversight best practices.
- Assist with financial oversight (forecasting, budget management, investment planning, and long-range portfolio planning).
- Partner with SM&H, GTO, CPS, and other clinical operations groups to align strategies and drive portfolio delivery.
Qualifications:
- Bachelorβs degree in Life Sciences or related field required; advanced degree preferred.
- 15+ yearsβ experience in global clinical trial execution (biopharma or CRO) with deep operational leadership across the full study lifecycle.
- Experience in one or more therapeutic areas: Cardiovascular, CNS, or Hematology/Blood Disorders.
- Proven success partnering with senior executives to translate strategy into operational execution.
- Track record influencing without direct authority across senior leadership.
- Expertise in clinical operations strategy, program planning, risk management, trial delivery models, and cross-functional execution.
- Experience developing/implementing operational frameworks, governance models, or delivery standards.
- Strong communication skills (written, verbal, presentation) and ability to synthesize complex information.
- Strong understanding of global regulatory expectations and clinical trial compliance.
- Ability to travel up to 30%.