Clinical Development Scientist, Director--Inflammation and Immunology (I&I) Non MD

Position Summary

Lead and coordinate the development of multiple clinical studies for novel biologic and small molecule therapies across various stages of clinical development within a given therapeutic area. Lead clinical protocol development and participate as an individual contributor on clinical study teams to support enrollment and study delivery timelines. Work closely with cross-functional partners to ensure the full scope and perspective of I&I are represented within clinical study teams, including Research Unit Clinicians, Global Clinical Leads/Medical Monitors, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine.

Position Responsibilities

• Provide scientific leadership for the design, execution, and interpretation of clinical studies, delivering innovative study designs, high-quality trial execution, safety assessments, and clinically meaningful study outcomes.
• Lead and support the development and execution of clinical development programs, operating independently within project teams.
• Serve as a technical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and contractors.
• Support the development of publications, abstracts, presentations, and scientific communications.
• Participate on project teams to support clinical development strategy, study implementation, and achievement of key development milestones, including the startup, conduct, and delivery of clinical studies.
• Lead preparation of clinical protocols and lead or contribute to other key study documents, including informed consent forms, study training materials, investigator brochures, statistical analysis plans, and regulatory documents.
• Lead clinical data review activities, including the collection, analysis, and interpretation of safety and efficacy data for safety review meetings and ongoing data review activities conducted in accordance with data review plans.
• Collaborate with study teams to maintain open and transparent communication and support successful study execution and completion.
• Foster a transparent environment that encourages strong partnerships and mutual trust across teams, sub-teams, and therapeutic areas.
• Develop effective partnerships with project leaders and cross-functional colleagues across Pfizer, including Biostatistics, Regulatory Affairs, Clinical Pharmacology, Clinical Operations, and other relevant functions.
• Be accountable to multiple project teams, core study teams, and clinical sub-teams while effectively managing priorities to support the startup, conduct, and closeout of clinical studies.
• Develop expertise in Pfizer clinical processes, checklists, and Standard Operating Procedures (SOPs) to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, Institutional Review Boards (IRBs), and Pfizer standards.
• Apply learnings to support continuous process improvement within the I&I organization.
• Develop expertise in Pfizer compliance systems, registries (e.g., GDMS, pTMF, Clinical Trial Registries), and other study systems (e.g., CORD, JReview, Signal Management), and apply lessons learned to improve study execution across the I&I organization.
• Partner with relevant functional lines to ensure biomarker strategies are incorporated into therapeutic area programs to support patient stratification, efficacy assessments, and clinical development objectives.
• Establish and maintain relationships with external experts, consultants, key opinion leaders (KOLs), regulators, and disease-specific investigator networks to ensure that evolving scientific and clinical insights are appropriately incorporated into development plans and study designs and to support study conduct, data interpretation, and dissemination of results.
• Maintain current knowledge of scientific and clinical literature relevant to I&I therapeutic areas and associated clinical development strategies.

Minimum Qualifications

• PhD/PharmD and 5+ years of relevant industry experience in clinical development, clinical research, or a related drug development role, with a demonstrated track record of supporting development programs through key milestones OR MS and 7+ years of relevant industry experience in clinical development, clinical research, or a related drug development role, with a demonstrated track record of supporting development programs through key milestones OR BSc and 8+ years of relevant industry experience in clinical development, clinical research, or a related drug development role, with a demonstrated track record of supporting development programs through key milestones.
• Deep understanding of the biopharmaceutical environment and clinical drug development, with familiarity across related disciplines including Biostatistics, Regulatory Affairs, Clinical Pharmacology, and Pharmaceutical Sciences.
• Experience developing and coaching others, guiding cross-functional teams, and driving meaningful business impact.
• Strong scientific writing, presentation, and verbal communication skills.
• Experience building consensus, influencing stakeholders, and driving change across all levels of the organization, including senior leadership.
• Strong experience reviewing clinical data listings and interpreting study data.

Preferred Qualifications

• Experience in Immunology clinical development
• Experience supporting Phase 2, Phase 3, and/or late-stage clinical development programs
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Physical/Mental Requirements

Ability to perform complex data analysis

Non-Standard Work Schedule, Travel or Environment Requirements

Occasional Travel 5-10%. Relocation support available. Work Location Assignment: Hybrid--Will work on-site an average of 2.5 days per week and must be commutable to the site.