Senior Manager, Late-Stage Oncology Clinical Development

Pfizer; Bothell (WA); Hybrid; USD 139,000 - 232,000; Full time

Benefits offered by this job

401(k) plan with matching

Retirement savings contribution

Paid vacation and holidays

Relocation assistance

Job summary

Pfizer in Bothell, WA is seeking a highly experienced Clinical Scientist to oversee scientific integrity and data quality for Late-Stage Oncology programs. You will collaborate with clinical operations and medical colleagues to execute trials, author key study documents, and drive data-driven decision making across complex, pivotal studies.

You will partner with safety and regulatory teams to monitor emerging data, provide strategic input, and ensure adherence to ICH/GCP guidelines in a global

Qualifications

• PhD/PharmD in a relevant science with minimum 2 years clinical research experience in industry/CRO.
• MS in a relevant science with minimum 5 years clinical research experience in industry/CRO.
• BA/BS in a relevant science with minimum 7 years clinical research experience in industry/CRO.
• Experience in oncology clinical trial development, solid tumor and/or heme.
• Phase 3/pivotal oncology experience with regulatory submissions, inspections, and approvals.
• Excellent knowledge of ICH, GCP, FDA/EMA regulations and global regulatory landscape.
• Experience leading cross-functional teams and communicating results to diverse stakeholders.

Responsibilities

• Clinical development expert for assigned studies, maintaining current scientific and clinical knowledge.
• Partner with clinical operations and other functions for successful trial execution.
• Responsible for scientific oversight, data integrity and quality of trials.
• Represent study team in governance meetings and support strategy discussions.
• Author protocols, informed consent documents, and contribute to regulatory documents and submissions.
• Set data review strategies and lead data quality reviews and trend analyses.
• Analyze emerging safety data and keep team informed of safety profile changes.
• Follow SOPs and regulations; lead or participate in process improvement initiatives.

Skills

Effective communication

Presentation skills

Organizational skills

Cross-functional collaboration

Scientific productivity

Education

PhD/PharmD

MS in science

BA/BS in science

Tools

Microsoft Office

Scientific software

Clinical data software

Job description

Pfizer in Bothell, WA is seeking a highly experienced Clinical Scientist to oversee scientific integrity and data quality for Late-Stage Oncology programs. You will collaborate with clinical operations and medical colleagues to execute trials, author key study documents, and drive data-driven decision making across complex, pivotal studies.

You will partner with safety and regulatory teams to monitor emerging data, provide strategic input, and ensure adherence to ICH/GCP guidelines in a global