Clinical Development Scientist, Senior Manager

Responsible for the scientific and clinical oversight of clinical trials in support of the development strategy for programs within the Inflammation & Immunology (I&I) portfolio. As an individual contributor, this role focuses on ensuring data integrity and quality for clinical trials across both early and late-stage development, based on portfolio and resourcing needs. The Senior Manager partners with other clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. The role is also expected to leverage AI tools and other innovative technologies to improve ways of working, enhance efficiency, reduce work redundancy and improve quality.

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 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 ongoing review of emerging clinical data for safety and efficacy trends, and 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; 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) and seeks opportunities to improve quality and efficiency of clinical development procedures; Contributes to the preparation for Health Authority meetings; May mentor junior team members

Requirements

Advanced degree (PhD, PharmD, MS) in a relevant scientific discipline is required; Non-MD role; PhD/PharmD with 2+ years of relevant experience in clinical research, or MS with 5+ years of relevant experience in clinical research; Demonstrated experience in clinical development within the pharmaceutical/biotechnology industry is required; Strong understanding of the drug development process, clinical trial design, and execution; Excellent knowledge of clinical procedures, ICH guidelines, and Good Clinical Practice (GCP); Proven scientific writing skills and strong verbal communication skills; Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate; Strong analytical, organizational, and project management skills with the ability to manage multiple projects and priorities; Candidates must be authorized to be employed in the U.S.; U.S. work visa sponsorship is not available for this role now or in the future; This position requires permanent work authorization in the United States

Nice to have

Experience in the Inflammation & Immunology (I&I) therapeutic area

Benefits

401(k) plan with Pfizer Matching Contributions and additional Pfizer Retirement Savings Contribution; Paid vacation, holiday and personal days; Paid caregiver/parental and medical leave; Health benefits including medical, prescription drug, dental and vision coverage; Eligibility for Pfizer's Global Performance Plan with a bonus target of 17.5% of base salary; Eligibility for share-based long term incentive program; Relocation assistance may be available based on business needs and/or eligibility