Senior Clinical Development Lead – Inflammation & I&I

Pfizer Inc.; Cambridge (MA); Hybrid; USD 139,000 - 232,000; Full time

Job summary

Pfizer Inc. in Cambridge, MA seeks a Senior Manager to provide scientific and clinical oversight of inflammatory therapy programs, ensuring data integrity across early and late-stage trials.

As an individual contributor, you will collaborate with Clinical Operations, Biostatistics, Regulatory Affairs and others, author essential documents, and lead data review. The role emphasizes ethical standards and the use of AI tools to enhance efficiency, while supporting site training and Health Authority

Qualifications

• Advanced degree in a relevant scientific discipline (PhD, PharmD, MS) required.
• PhD/PharmD with 2+ years of clinical research experience or MS with 5+ years of clinical research experience.
• Experience in clinical development within the pharmaceutical/biotechnology industry is required.
• Experience in the Inflammation & I&I therapeutic area is preferred but not required.
• Strong understanding of the drug development process, clinical trial design, and execution.

Responsibilities

• Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Authors and reviews key clinical and regulatory documents including, but not limited to, protocols, study-level informed consent forms (ICFs), Investigator's Brochures (IBs), clinical study reports (CSRs), and regulatory submission components.
• Leads the clinical data review strategy, including the ongoing review of emerging clinical data for safety and efficacy trends. Presents relevant data to internal teams, governance bodies, and other stakeholders.
• Collaborates with cross-functional team members (e.g., Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology) to ensure trial objectives are met and activities are executed seamlessly.
• Provides scientific and clinical input for site training materials and supports responses to questions from investigators and site personnel regarding the protocol and study conduct.
• Ensures compliance with relevant SOPs, regulations, and Good Clinical Practice (GCP); seeks opportunities to improve quality and efficiency of clinical development procedures and may participate in process improvement workgroups.
• Contributes to the preparation for Health Authority meetings and may participate as appropriate.
• May mentor junior team members.

Skills

Clinical development

Scientific writing

Cross-functional collaboration

Data integrity

AI tools

Education

Advanced degree in scientific discipline (PhD/PharmD/MS)

Tools

AI tools

Job description

Pfizer Inc. in Cambridge, MA seeks a Senior Manager to provide scientific and clinical oversight of inflammatory therapy programs, ensuring data integrity across early and late-stage trials.

As an individual contributor, you will collaborate with Clinical Operations, Biostatistics, Regulatory Affairs and others, author essential documents, and lead data review. The role emphasizes ethical standards and the use of AI tools to enhance efficiency, while supporting site training and Health Authority