Oncology Late Stage Clinical Development Scientist (Non MD)--Multiple Openings- Director
About The Position
The Oncology Late Stage Clinical Development Scientist provides scientific oversight, data integrity, and quality for clinical trials supporting development strategies within the Late-Stage Oncology portfolio. The role serves as a clinical development expert for assigned studies and works closely with clinical and medical colleagues, clinical operations, and other functions to implement and execute trials. The scientist represents study teams in governance meetings and submissions and supports the Development Lead or Medical Director on study and disease-area strategy. The position authors protocols and study-level informed consent documents and contributes to investigator brochures, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents. It establishes clinical data review strategies, leads review of emerging data and trends, and partners with medically qualified colleagues to monitor and communicate the drug's evolving safety profile. The role also follows applicable procedures and regulations and may lead or contribute to initiatives that improve clinical development processes. This is a hybrid role requiring residence within commuting distance and on-site work an average of 2.5 days per week. The position is eligible for a performance bonus with a target of 20% of base salary and participation in a share-based long-term incentive program. Candidates must be authorized to work in the United States; U.S. work visa sponsorship is unavailable.
Requirements
- PhD or PharmD in a relevant science discipline and at least 5 years of clinical research experience in industry or a CRO; or an MS in a relevant science discipline and at least 7 years of such experience; or a BA/BS in a relevant science discipline and at least 10 years of clinical research experience in a similar industry or CRO role.
- Clinical research experience in Phase 3 or pivotal oncology studies, ideally on the sponsor side, with a track record of successful regulatory submission, inspection, and approval.
- Solid tumor or hematology clinical trial experience.
- Experience leading a team.
- Excellent knowledge of clinical procedures, ICH guidelines, and GCP, and familiarity with FDA, EMA, and global regulations.
- Extensive understanding of related disciplines, including Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, and Quality Assurance.
- Experience working with large data sets.
- Proficiency with Microsoft Office and relevant scientific software.
- Effective communication, presentation, and organizational skills to support coordinated and timely delivery.
- Experience using a variety of communication tools and techniques to communicate results.
- Experience solving problems collaboratively and handling conflict constructively.
- Track record of scientific productivity demonstrated through publications, posters, abstracts, or presentations.
- Ability to work proactively and independently and organize one's own and others' tasks, time, and priorities.
- Experience building partnerships across a company to meet program needs.
- Ability to adapt to a changing work environment while maintaining integrity and quality.
- Ability to deliver autonomously, solve problems, and make agile decisions in clinical responsibilities.
- Ability to leverage knowledge and support from others, exercise judgment in complex decisions, and promote innovation and appropriate risk-taking.
- Ability to work effectively in diverse, global teams and embrace evolving technologies and best practices.
- Must be authorized to work in the United States by any employer and have permanent U.S. work authorization; U.S. work visa sponsorship is not available.
Nice To Haves
- Clinical research experience on the sponsor side.
- Experience supporting successful regulatory submissions, inspections, and regulatory approvals.
Responsibilities
- Maintain current scientific and clinical knowledge in the assigned therapeutic and disease areas and provide clinical development expertise for assigned studies.
- Partner with clinical and medical colleagues, clinical operations, and other functional teams to implement and execute clinical trials.
- Provide scientific oversight and ensure data integrity and quality for clinical trials.
- Represent the study team in governance meetings and submissions, and support the Development Lead or Medical Director on study and disease-area strategy.
- Author protocols and study-level informed consent documents, and contribute to investigator brochures, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents.
- Support preparation for Health Authority meetings and participate as appropriate.
- Set the clinical data review strategy and lead collection of quality data and review of emerging clinical data and trends.
- Review and query data, and present and discuss relevant findings with teams, governance bodies, and internal and external stakeholders.
- Partner with medically qualified colleagues to analyze the emerging safety profile of the drug and keep clinical and safety colleagues informed of changes.
- Follow applicable SOPs, regulations, and training requirements, and seek opportunities to improve the quality and efficiency of clinical procedures.
- Lead or actively participate in portfolio- and enterprise-level workgroups to optimize clinical development procedures; may serve as a subject matter expert or business process owner for a relevant SOP or procedure.
- Influence and collaborate with peers, develop and coach others, and oversee and guide colleagues' work to achieve outcomes and business impact.
Benefits
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
- Paid vacation, holiday, and personal days.
- Paid caregiver, parental, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
- Participation in Pfizer's Global Performance Plan with a bonus target of 20% of base salary.
- Eligibility to participate in a share-based long-term incentive program.
- Relocation assistance may be available based on business needs and/or eligibility.
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What This Job Offers
Job Type
Full-time
Career Level
Director
