Job SummaryThe Sr. Manager, Clinical Development Scientist is accountable for the scientific integrity of the study and the well‑being of patients enrolled in one or more clinical trials. The role applies technical and clinical skills to ensure the design of efficient and high‑quality clinical trials, employing quantitative design principles and clinical best practices to deliver both clinical and operational excellence.ResponsibilitiesProvides clinical input to support development of the protocol design document (PDD).Leads or supports development of the protocol from the approved PDD and ensures efficient protocols that maximize operational efficiency, trial quality and participant/site engagement while minimizing the likelihood of amendments or quality issues.Provides clinical input to develop data collection tools and responsible for SAP, TLFs, and BDR.Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.Reviews, reports and manages protocol deviations.Reviews patient level and cumulative data per the data review plan across one or more studies.Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (e.g. ICD) are updated as required. Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.Ensures TMF compliance for clinical documents.Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection.May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, Periodic Safety Update Reports and Regulatory authority responses) if required.May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs).Contributes to continuous improvement/process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.QualificationsBasic QualificationsBA/BS or equivalent qualification with 6+ years of experience in biopharmaceutical industry in clinical research and development.MBA or MS equivalent with 5+ years of experience.Advanced Degree with 1+ years of experience.Demonstrated clinical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English, in relating to individuals both inside and outside Pfizer.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.Preferred QualificationsClinical research experience in phase 3/pivotal space highly preferred.Cardiometabolic disease experience highly preferred (e.g., cardiology, obesity, endocrinology, nephrology etc).Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.TravelGlobal travel may be required.Legal & ComplianceSunshine Act – 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. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer 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,, 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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