Oncology Late Stage Clinical Development Scientist (Non MD)--Multiple Openings- Director at Pfizer | CT, US | Rezi

Oncology Late Stage Clinical Development Scientist (Non MD)--Multiple Openings- Director at Pfizer

Oncology Late Stage Clinical Development Scientist (Non MD)--Multiple Openings- Director

Pfizer · CT, US

2 days ago

Oncology Late Stage Clinical Development Scientist (Non MD)--Multiple Openings- Director

Pfizer · CT, US

2 days ago
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About the Role

Responsible for scientific oversight, data integrity, and quality of clinical trials in support of the development strategy for programs within the Late-Stage Oncology portfolio.

Responsibilities

  • Serve as the clinical development expert for assigned studies, maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s).
  • Partner effectively with other clinical and medical colleagues, clinical operations, and other functional lines for successful clinical trial implementation and execution.
  • Represent the study team in governance meetings and submissions, supporting the Development Lead/Medical Director regarding study and disease area strategy.
  • Author protocols, study-level informed consent documents, and contribute to IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents.
  • Support preparations 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, presenting and discussing relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
  • Analyze the emerging safety profile of the drug in partnership with medically qualified colleagues, keeping clinical and safety colleagues informed of changes.
  • Follow relevant SOPs and regulations, ensuring compliance with applicable trainings.
  • Seek opportunities to improve the quality and efficiency of clinical procedures.
  • Lead or actively participate in portfolio- and enterprise-level workgroups aimed at optimizing PFE clinical development procedures.
  • May act as a subject matter expert or business process owner for a relevant SOP or procedure.

Requirements

  • PhD/PharmD 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 from the sponsor side with a track record of successful regulatory submission, inspection, and regulatory approval.
  • Solid tumor or hematology clinical trial experience.
  • Experience leading a team.
  • 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 program needs.
  • 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.
  • 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 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.
  • 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.
  • Permanent work authorization in the United States is required.
  • U.S. work visa sponsorship is not available for this role now or in the future.

Skills

  • Clinical development
  • Data integrity
  • Data quality
  • Clinical trial management
  • Scientific knowledge
  • Clinical knowledge
  • Therapeutic area expertise
  • Disease area expertise
  • Cross-functional collaboration
  • Protocol authoring
  • Informed consent document authoring
  • Investigator Brochure (IB) authoring
  • Site training material development
  • Clinical Study Report (CSR) authoring
  • Regulatory document authoring
  • Health Authority meeting preparation
  • Clinical data review
  • Quality data collection
  • Emerging clinical data analysis
  • Safety profile analysis
  • Regulatory compliance
  • ICH guidelines
  • GCP
  • FDA regulations
  • EMA regulations
  • Global regulations
  • Microsoft Office proficiency
  • Scientific software proficiency
  • Communication skills
  • Presentation skills
  • Organizational skills
  • Problem-solving
  • Conflict resolution
  • Scientific productivity
  • Proactive work ethic
  • Independent work
  • Time management
  • Priority management
  • Partnership building
  • Leadership
  • Coaching
  • Influencing
  • Collaboration

Location

  • Hybrid

Work Type

  • Hybrid
  • Full-time

Experience Level

  • 5 years Clinical Research experience
  • 7 years Clinical Research experience
  • 10 years Clinical Research experience
  • Experience leading a team
  • Experience working on large data sets
  • Experience leveraging a variety of communication tools and techniques
  • Experience solving problems collaboratively
  • Experience handling conflict constructively
  • Experience working proactively and independently
  • Experience organizing tasks, time and priorities of self and others
  • Experience building partnerships across the company
  • Breadth of diverse leadership experiences and capabilities

Education Level

  • PhD/PharmD in a relevant Science discipline
  • MS in a relevant Science discipline
  • BA/BS in a relevant Science discipline

Salary/Compensations

  • $176,600.00 - $294,300.00
  • Bonus target of 20.0% of the base salary
  • Eligibility to participate in share based long term incentive program

Benefits

  • Comprehensive and generous benefits and programs
  • 401(k) plan with Pfizer Matching Contributions
  • Additional Pfizer Retirement Savings Contribution
  • Paid vacation, holiday and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits to include medical, prescription drug, dental and vision coverage
  • Relocation assistance may be available

About the Company

  • Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
  • Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
  • Pfizer is an E-Verify employer.
  • Pfizer endeavors to make www.pfizer.com/careers accessible to all users.
  • To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Equal Opportunity

  • Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
  • Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
  • Pfizer is an E-Verify employer.