Pfizer

Late-Stage Oncology Clinical Scientist, Director, Non MD

Pfizer

full-time

Posted on:

Origin:  • 🇺🇸 United States • California, Massachusetts, New York, Washington

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Salary

💰 $169,700 - $282,900 per year

Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • 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.
  • You may have managerial responsibility for one or more direct reports and/or contingent worker(s).
  • 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, partner with/support 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 lead the team in the collection of quality data and review of emerging clinical data and trends; review and query data; present and discuss 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.
  • May have managerial responsibility for other Clinical Scientists or contingent workers assigned to the project; may supervise, mentor, and/or develop others.

Requirements

  • Relevant PhD or PharmD and a minimum of 7 years of experience in a similar role in industry/CRO, OR MS and a minimum of 9 years of experience in a similar role in industry/CRO, OR BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
  • Clinical Research experience in the Phase 3/pivotal space in Oncology, on the side of the sponsor leading studies
  • Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations.
  • Strong scientific writing skills and communication skills (written and verbal)
  • Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations.
  • Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance.
  • Experience building consensus and driving change across all levels of the organization including senior management.
  • Data listing review experience
  • Experience working collaboratively in a fast-paced, team-based matrix environment as well as independently
  • Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform
  • PREFERRED QUALIFICATION Experience leading a team
  • 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.