Director, I&I Clinical Development (Non-MD)

Pfizer; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

Pfizer seeks a seasoned clinical development leader to oversee the design, execution, and interpretation of multiple studies across therapeutic areas. You will drive protocol development, contribute as an IC on study teams, and coordinate with cross-functional groups to ensure enrollment and delivery timelines are met.

You will lead activities across the development continuum, manage study documents, and ensure compliance with GCP, IRBs, and Pfizer standards while fostering strong partnerships

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.
• 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.
• 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

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.

Skills

Clinical development

Education

PhD/PharmD

MS

BSc

Job description

Pfizer seeks a seasoned clinical development leader to oversee the design, execution, and interpretation of multiple studies across therapeutic areas. You will drive protocol development, contribute as an IC on study teams, and coordinate with cross-functional groups to ensure enrollment and delivery timelines are met.

You will lead activities across the development continuum, manage study documents, and ensure compliance with GCP, IRBs, and Pfizer standards while fostering strong partnerships