Scientist Jobs

About The Position

Requirements

• PhD or PharmD in a relevant science discipline and at least 2 years of Clinical Research experience in industry or a CRO; or an MS in a relevant science discipline and at least 5 years of such experience; or a BA/BS in a relevant science discipline and at least 7 years of Clinical Research experience in a similar industry or CRO role.
• Experience in oncology clinical trial development, including solid tumors and/or hematologic malignancies.
• Clinical Research experience in Phase 3 or pivotal oncology trials.
• Knowledge of clinical procedures, ICH guidelines, GCP, and FDA, EMA, and global regulations.
• 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.
• Collaborative problem-solving skills and the ability to handle conflict constructively.
• Experience working proactively and independently and organizing personal and team tasks, time, and priorities.
• Experience building partnerships across a company to meet program needs.

Nice To Haves

• Phase 3 or pivotal oncology trial experience on the sponsor side, with a track record of successful regulatory submission, inspection, and approval.
• A track record of scientific productivity evidenced by publications, posters, abstracts, and/or presentations.

Responsibilities

• Maintain current scientific and clinical knowledge in assigned therapeutic and disease areas.
• Partner with clinical and medical colleagues, clinical operations, and other functions to implement and execute assigned clinical trials.
• Provide scientific oversight and ensure the data integrity and quality of clinical trials.
• Represent study teams 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 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 data with appropriate 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 relevant SOPs, regulations, and applicable training requirements.
• Identify 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.
• Potentially serve as a subject matter expert or business process owner for a relevant SOP or procedure.

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
• Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 17.5% 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