Hybrid Oncology Late Stage Clinical Scientist – Senior Manager

Posted 6 days ago

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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.
  • 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.

Requirements

  • PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO
  • OR MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry/CRO
  • OR BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO
  • Clinical Research experience in the phase 3/pivotal space in Oncology
  • 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

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
  • health benefits to include medical, prescription drug, dental and vision coverage

Job title

Oncology Late Stage Clinical Scientist – Senior Manager

Job type

Experience level

Senior

Salary

$135,100 - $225,100 per year

Degree requirement

Postgraduate Degree

Location requirements

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