Clinical Development Scientist, Director

Clinical Development Scientist, Director

United States - Washington – Bothell
United States - Pennsylvania - Collegeville
United States - New York - New York City
United States - Massachusetts - Cambridge

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

The Clinical Development Scientist (Director) ensures scientific integrity and participant safety in clinical trials, designs and executes high‑quality studies, maintains compliance, manages risks and emerging clinical issues, and supports interpretation and communication of clinical data. This role is the primary contact for internal and external stakeholders for clinical aspects of the protocol, supports strategic development, and may provide matrix management.

• Leadership
  • Autonomously and independently leads clinical execution of one or more studies of medium–high complexity and significant business impact. May be accountable for program‑level clinical deliverables.
  • Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
  • May provide matrix management support to one or more clinical colleagues.
• Content Creation
  • Provides clinical input to support development of the protocol design document (PDD).
  • Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with / supports the Global Development Lead in governance review and approval process.
  • Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
  • Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Clinical & Safety Oversight
  • Provides clinical input to the development of data collection tools.
  • Responsible for providing clinical input to statistical analysis plan (SAP), tables, listings, figures (TLFs) and blinded data review (BDR).
  • Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
  • Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
  • Inputs to, reviews and approves, Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc.) to develop and implement any risk mitigations.
  • Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
  • Serves as the primary contact with external investigators and internal study team for questions relating to clinical aspects of protocol.
  • 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, serious adverse event (SAE) reports, targeted medical events (TMEs), designated medical events (DMEs) and ensures clinical documents (e.g. ICD) are updated as required.
  • Tracks and reconciles SAEs across a study and leads presentation of data during Safety Review Team meetings.
  • Ensures trial master file (TMF) compliance for clinical documents.
• Clinical Reporting
  • May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator…