You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within our 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; PhD / Pharm D 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 2 - 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
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
Track record of scientific productivity as evidenced by publications, posters, abstracts and / or presentations
Experience building partnerships across the company to achieve the needs of the program
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 in the work assigned
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
Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes
Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development
Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. 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
In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% 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. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.Pfizer compensation structures and benefit packages are aligned based on the location of hire. Relocation assistance may be available based on business needs and / or eligibility.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. 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. This position requires permanent work authorization in the United States.
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Clinical Scientist • Collegeville, PA, US