Pfizer · 19 hours ago
Director, Clinical Development Scientist (Non-MD)
Bothell, WA
Full-time
Hybrid
Lead/Staff, Director/Executive
$177K/yr - $283K/yr
5+ years expPfizer is a leading biopharmaceutical company, and they are seeking a Director, Clinical Development Scientist to ensure the scientific integrity of clinical trials and the well-being of patients. The role involves leading the execution of clinical studies, maintaining compliance with standards, and collaborating with various teams to deliver high-quality clinical trial outcomes.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
No H1B
U.S. Citizen Only
Responsibilities
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
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
Provides clinical input to the development of data collection tools. Responsible for providing clinical input to SAP, TLFs and BDR
Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions
Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes
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, SAE reports, TME’s, DME’s and ensures clinical documents (eg 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, and 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
May provide matrix management support to one or more clinical colleagues
Qualification
Required
Advanced degree or professional certification in a health care related, scientific or technical discipline required
5+ years of experience and track record of success in biopharmaceutical industry in clinical research and development
Clinical research experience in phase 3/pivotal space
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
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
Demonstrated experience establishing, managing, and training teams in clinical development
Preferred
Cardiometabolic Disease experience highly preferred (ie; cardiology, obesity endocrinology, nephrology, etc)
Benefits
Participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary
Eligibility to participate in our share based long term incentive program
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
Health benefits to include medical, prescription drug, dental and vision coverage
Company
Pfizer
Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$38BKey Investors
Starboard Value
2025-11-21Post Ipo Debt· $6B
2024-10-07Post Ipo Equity· $1B
2023-05-16Post Ipo Debt· $31B
Leadership Team
Albert Bourla
Chief Executive Officer
Ian Read
Chief Executive Officer
Recent News
2026-01-24
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2026-01-24
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