AI-Driven Senior Clinical Development Lead (I&I)

Regulatory Jobs; Cambridge (MA); Hybrid; USD 139,000 - 232,000; Full time

Benefits offered by this job

401(k) plan with Pfizer Matching

Pfizer Retirement Savings Contribution

Paid vacation

Holiday and personal days

Paid caregiver/parental and medical-le

Health benefits

Job summary

Pfizer seeks an experienced Senior Manager to provide scientific and clinical oversight of clinical trials in the Inflammation & Immunology portfolio. As an individual contributor, you ensure data integrity and quality across early and late-stage development, aligning with the development strategy.

You will partner with clinical, medical, operations and regulatory teams to execute trials with high scientific and ethical standards.

Qualifications

• PhD/PharmD with 2+ years of relevant experience in clinical research.
• MS with 5+ years of relevant experience in clinical research.
• Experience in clinical development within the pharmaceutical/biotechnology industry.
• Knowledge of ICH guidelines and Good Clinical Practice (GCP).
• Excellent scientific writing and strong verbal communication skills.

Responsibilities

• Maintains current scientific and clinical knowledge in assigned therapeutic areas.
• Authors and reviews clinical/regulatory documents (protocols, ICFs, IBs, CSRs).
• Leads the clinical data review strategy and presents data to stakeholders.
• Collaborates across Clinical Operations, Biostatistics, Regulatory Affairs, and Clinical Pharmacology.
• Provides input for site training materials and responds to investigator questions.
• Ensures compliance with SOPs, regulations, and GCP; seeks quality improvements.

Education

PhD

PharmD

MS

Job description

Pfizer seeks an experienced Senior Manager to provide scientific and clinical oversight of clinical trials in the Inflammation & Immunology portfolio. As an individual contributor, you ensure data integrity and quality across early and late-stage development, aligning with the development strategy.

You will partner with clinical, medical, operations and regulatory teams to execute trials with high scientific and ethical standards.