Oncology Late Stage Clinical Development Scientist (Non MD, Director) Full-time

Late-Stage Oncology Clinical Trial Scientist

You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.

Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.

Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program.

Responsible for scientific oversight, data integrity and quality of the clinical trial(s).

Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.

Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.

Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.

In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).

Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.

PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR

MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR

BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO

Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval

Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations

Extensive understanding of related disciplines, e.g., 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

Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery

Experience leveraging a variety of communication tools and techniques to communicate results

Experience solving problems collaboratively and handling conflict constructively

Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations

Experience working proactively and independently, organizing tasks, time and priorities of self and others

Experience building partnerships across the company to achieve the needs of the program

Experience in Oncology, specifically Genitourinary Cancer

Experience leading direct reports and/or contract employees

Demonstrates passion for helping patients with cancer and for the science of oncology

Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned

Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities

Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes

Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies

Demonstrates foresight and judgment to make complex decisions

Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes

Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development

Has a global perspective and mindset. Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

The annual base salary for this position ranges from $176,600.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.