Clinical Development Scientist, Manager

Summary

The Clinical Development Scientist (Manager) provides support of scientific oversight, data integrity, and quality of clinical trials in support of the development strategy for programs within the Internal Medicine portfolio

Job Responsibilities

• Content Creation

  • Contributes to and supports other clinical colleagues with development of efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Supports the Global Development Lead in governance review and approval process

  • Contributes to and supports other clinical colleagues with development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters

  • Contributes to and supports other clinical colleagues with development of Informed Consent Documents (ICDs)

• Clinical & Safety Oversight

  • Contributes to and supports other clinical colleagues with development of data collection tools.

  • Contributes to and supports other clinical colleagues with establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.

  • Contributes to and supports other clinical colleagues with Risk Management and Safety Review Plan. Supports activities consistent with the approved plan and implementation of risk mitigations.

  • Contributes to and supports clinical colleagues with review and approval of country selection, site selection criteria, and 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, and DME’s, and contributes to and supports clinical colleagues with safety data review meetings and clinical document (eg ICD) updates as required.

  • Contributes to and supports clinical colleagues with TMF compliance for clinical documents.

• Clinical Reporting

  • Contributes to and supports clinical colleagues with authoring clinical sections of regulatory documents (e.g., Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports, Clinical trial applications, and responses to regulatory requests) if required.

  • Contributes to and supports clinical colleagues with authoring and review of the Clinical Study Report including the review of safety narratives; disclosure of safety and efficacy data and trial conclusions; and publication of clinical trial results.

  • Provides clinical support to the study team or clinical program in response to audits or inspections

Basic Qualifications

• Years of experience in biopharmaceutical industry in clinical research and development:

  • BA/BS with 4+ years of experience

  • MA or MS with 2+ years of experience

  • PhD with 0+ 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.

• Demonstrates a passion for helping patients

• Proven analytical skills with the ability to work on large data sets

• Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery

• Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English

• Has a global perspective and mindset works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor; works effectively with internal and external partners and investigators/medical professionals

• Proficient with basic IT; efficiently using a computer and telecommunications (voice and video)

• Has the flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned

• Must have the relevant personality features and competencies supporting the responsibilities:

  • Demonstrates effective problem-solving, and agile decision-making in execution of clinical responsibilities

  • Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and p