Role Summary
The Head of Clinical Excellence & Innovation – I&I will be a pivotal leader driving the company’s clinical innovation and excellence across Pfizer’s global I&I portfolio. Based in Cambridge, Massachusetts, this role sets and executes a vision for clinical program performance, leveraging technology, data, and industry-leading strategies to accelerate the development of transformative therapies in I&I.
Responsibilities
- Strategic Oversight & Vision: Shape and drive the strategic direction for I&I clinical programs, championing the adoption of innovative trial designs while upholding rigorous scientific and regulatory standards.
- Team Leadership & Culture: Inspire, mentor, and develop clinical leaders and scientists in I&I drug development, fostering innovation, accountability, and continuous learning, with direct responsibility for physicians and clinical scientists not reporting to other I&I heads.
- Technology & Data Leadership: Lead integration of AI, digital health solutions, and advanced analytics to transform trial operations, improve data integrity, and enable data-driven decision-making.
- Process Optimization: Identify, implement, and scale best practices to streamline processes, boost operational efficiency, and build a flexible clinical infrastructure to support Pfizer’s growth.
- External Engagement: Represent Pfizer at scientific conferences, regulatory forums, and partner/investor engagements; cultivate relationships with KOLs, CROs, academic collaborators, and regulators.
- Cross-Functional Partnership: Collaborate with Medical Affairs, Regulatory, Safety, Operations, and Business Development to harmonize and advance I&I clinical strategies and standards.
- Industry Foresight: Monitor evolving scientific and competitive landscapes, leveraging new technologies to inform Pfizer’s I&I clinical strategy.
Qualifications
- Required: M.D. with at least 10 years’ experience leading development I&I clinical trials.
- Required: Proven success in I&I clinical project/program management, with experience in both large pharma and nimble biotech environments.
- Required: Deep understanding of I&I drug development, protocol writing, study conduct, data analysis, and regulatory submissions.
- Required: Strong leadership and interpersonal skills, with ability to manage and mentor teams and collaborate with diverse stakeholders.
- Required: Expertise in process improvement, change management, and digital transformation within clinical research.
- Required: Experience with global I&I regulatory submissions and interactions with major regulatory agencies.
- Required: Demonstrated experience engaging with CROs, KOLs, regulatory authorities, and the broader I&I research community.
- Required: Track record of leveraging data, technology, and innovative approaches to scale clinical operations and deliver value for patients.
Skills
- Leadership and people management
- Strategic thinking and program management
- Digital health, AI, and advanced analytics literacy
- Cross-functional collaboration and stakeholder engagement
- Regulatory strategy and submissions
- Process optimization and change management
- Data quality and governance
Education