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 such experience in a similar industry or CRO role.
• Experience in oncology clinical trial development.
• Solid tumor and/or hematologic oncology Clinical Research experience in Phase 3 or pivotal trials; sponsor-side experience and a record of successful regulatory submission, inspection, and approval are ideally sought.
• 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 ensure 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, evidenced by publications, posters, abstracts, and/or presentations.
• Ability to work proactively and independently and organize tasks, time, and priorities for oneself and others.
• Experience building partnerships across a company to meet program needs.
• Demonstrated ability to make complex decisions, exercise judgment, solve problems, and make decisions autonomously in clinical work.
• Ability to adapt to a changing work environment while maintaining integrity and quality.
• Ability to work effectively in diverse teams across cultures, backgrounds, and geographies, both as a leader and contributor.
• Breadth of leadership experience and capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing or guiding colleagues' work.
• Must be authorized to work in the United States for any employer; U.S. work visa sponsorship is unavailable.
• Requires permanent work authorization in the United States.

Nice To Haves

• Sponsor-side experience in Phase 3/pivotal oncology trials.
• A track record of successful regulatory submission, inspection, and regulatory approval.
• Experience leading or participating in portfolio- and enterprise-level workgroups to improve clinical development procedures.
• Experience as a subject matter expert or business process owner for an SOP or procedure.

Responsibilities

• Maintain current scientific and clinical knowledge in the therapeutic and disease areas relevant to assigned studies.
• Partner with clinical and medical colleagues, Clinical Operations, and other functional teams to implement and execute assigned clinical trials.
• Provide scientific oversight and ensure the data integrity and quality of 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; 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 the team in collecting quality data and reviewing emerging clinical data and trends.
• Review and query data, and present and discuss relevant data 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 relevant SOPs and regulations and comply with applicable training requirements.
• Identify opportunities to improve the quality and efficiency of clinical procedures.
• Lead or participate in portfolio- and enterprise-level workgroups aimed at optimizing clinical development procedures.
• Potentially serve as a subject matter expert or business process owner for a relevant SOP or procedure.
• Collaborate across the company, influence peers, and guide or develop colleagues to achieve program outcomes.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• Paid vacation, holidays, 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 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