Oncology Late Stage Clinical Development Scientist (Non MD, Director)
Pfizer
2 days ago
Remote friendly (South San Francisco, CA)
United States
$176,600 - $282,900 USD yearly
Clinical Research and Development
Key Responsibilities:
- Serve as clinical development expert for assigned studies, maintaining current scientific and clinical knowledge in the relevant therapeutic/disease areas.
- Partner with clinical/medical colleagues, clinical operations, and other functional lines to implement and execute clinical trials within the assigned program.
- Provide scientific oversight and ensure data integrity and quality for clinical trials.
- Represent the study team in governance meetings and submissions; partner with/support the Development lead/Medical Director on study and disease area strategy.
- Author protocols and study-level informed consent documents; contribute to IBs, site training materials, clinical study reports, regulatory responses, and other clinical/regulatory documents; support Health Authority meeting preparations.
- Define clinical data review strategy; lead collection and review of quality data and emerging clinical trends; review/query data; present/discuss data with relevant internal/external stakeholders.
- In partnership with medically qualified colleagues, analyze emerging drug safety and keep clinical/safety teams informed of safety changes.
- Follow applicable SOPs and regulations; comply with required trainings; continuously seek quality/efficiency improvements; lead/participate in workgroups to optimize clinical development procedures; act as SME/business process owner for relevant SOPs/procedures.
Minimum Qualifications:
- PhD/PharmD in relevant science with 5+ years Clinical Research experience in industry/CRO, OR MS with 7+ years, OR BA/BS with 10+ years.
- Phase 3/pivotal Oncology clinical research experience; ideally sponsor-side with successful regulatory submission, inspection, and approval track record.
- Strong knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA/EMA and global regulations.
- Broad understanding of related functions (Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance).
- Experience working on large data sets.
- Proficiency with Microsoft Office and relevant scientific software.
- Strong communication, presentation, and organizational skills; collaborative problem-solving; conflict resolution.
- Track record of scientific productivity (publications/posters/abstracts/presentations).
- Ability to work proactively and independently; manage tasks, time, and priorities.
- Experience building internal partnerships to meet program needs.
Preferred Qualifications:
- Oncology experience, specifically Genitourinary Cancer.
- Experience leading direct reports and/or contract employees.
- Serve as clinical development expert for assigned studies, maintaining current scientific and clinical knowledge in the relevant therapeutic/disease areas.
- Partner with clinical/medical colleagues, clinical operations, and other functional lines to implement and execute clinical trials within the assigned program.
- Provide scientific oversight and ensure data integrity and quality for clinical trials.
- Represent the study team in governance meetings and submissions; partner with/support the Development lead/Medical Director on study and disease area strategy.
- Author protocols and study-level informed consent documents; contribute to IBs, site training materials, clinical study reports, regulatory responses, and other clinical/regulatory documents; support Health Authority meeting preparations.
- Define clinical data review strategy; lead collection and review of quality data and emerging clinical trends; review/query data; present/discuss data with relevant internal/external stakeholders.
- In partnership with medically qualified colleagues, analyze emerging drug safety and keep clinical/safety teams informed of safety changes.
- Follow applicable SOPs and regulations; comply with required trainings; continuously seek quality/efficiency improvements; lead/participate in workgroups to optimize clinical development procedures; act as SME/business process owner for relevant SOPs/procedures.
Minimum Qualifications:
- PhD/PharmD in relevant science with 5+ years Clinical Research experience in industry/CRO, OR MS with 7+ years, OR BA/BS with 10+ years.
- Phase 3/pivotal Oncology clinical research experience; ideally sponsor-side with successful regulatory submission, inspection, and approval track record.
- Strong knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA/EMA and global regulations.
- Broad understanding of related functions (Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance).
- Experience working on large data sets.
- Proficiency with Microsoft Office and relevant scientific software.
- Strong communication, presentation, and organizational skills; collaborative problem-solving; conflict resolution.
- Track record of scientific productivity (publications/posters/abstracts/presentations).
- Ability to work proactively and independently; manage tasks, time, and priorities.
- Experience building internal partnerships to meet program needs.
Preferred Qualifications:
- Oncology experience, specifically Genitourinary Cancer.
- Experience leading direct reports and/or contract employees.