Description
You will be 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.
Key Responsibilities
- Provide clinical development expertise for assigned studies, maintaining current scientific and clinical knowledge in specific therapeutic and disease areas.
- Partner with clinical and medical colleagues, clinical operations, and other functional lines for successful implementation and execution of clinical trials.
- Ensure scientific oversight, data integrity, and quality of clinical trials.
- Represent the study team in governance meetings and submissions, and support the Development lead/Medical Director regarding study and disease area strategy.
- Author protocols, study-level informed consent documents, and contribute to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents.
- Set the clinical data review strategy, lead the team in collecting quality data, and review emerging clinical data and trends.
- Analyze the emerging safety profile of the drug, keeping clinical and safety colleagues informed of changes.
- Follow relevant SOPs and regulations, and seek opportunities to improve quality and efficiency of clinical procedures.
Minimum Qualifications
- 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.
- Experience in oncology clinical trial development, solid tumor and/or heme.
- 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.
Competencies for Success
- Demonstrates passion for helping patients with cancer and for the science of oncology.
- Flexibility to adapt and navigate through an ever-changing work environment.
- Demonstrates autonomous delivery, problem-solving, and agile decision-making.
- 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.
Work Location Assignment This is a Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.
Salary and Benefits The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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.