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Pfizer · 3 hours ago

Oncology Late Stage Clinical Scientist (Senior Manager, Non MD)

La Jolla, CA

Full-time

Hybrid

Mid, Senior Level

$135K/yr - $225K/yr

2+ years exp

Pfizer is a leading pharmaceutical company focused on innovative health solutions. They are seeking a Senior Manager to oversee scientific integrity and quality in late-stage oncology clinical trials, ensuring effective collaboration and regulatory compliance.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

U.S. Citizen Only

Responsibilities

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

Qualification

Clinical Research experienceOncology expertiseRegulatory submission experienceICH guidelinesMicrosoft Office proficiencyData analysis skillsEffective communicationProblem-solving skillsOrganizational skillsTeam collaboration

Required

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, 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