Clinical Development Scientist, Director
Pfizer
4 hours ago
Remote friendly (Andover, MA)
United States
$176,600 - $282,900 USD yearly
Clinical Research and Development
Clinical Development Scientist (Director)
Job Responsibilities
- Leadership: Independently leads clinical execution of one or more medium–high complexity studies with significant business impact (may be accountable for program-level clinical deliverables). Contributes to continuous improvement/process enhancement and innovative approaches to maximize trial execution effectiveness. May provide matrix management support.
- Content Creation: Provides clinical input to support development of the protocol design document (PDD). Leads protocol development from the approved PDD to maximize operational efficiency, trial quality, and participant/site engagement while minimizing amendments and quality issues. Partners with the Global Development Lead in governance review/approval. 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 data collection tools; statistical analysis plan (SAP), tables/listings/figures (TLFs), and blinded data review (BDR). Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees (charters/contracts/provision of data and documentation of outcomes). Provides clinical input to the Integrated Quality Management Plan (IQMP) and reviews/approves the final document. Inputs to/reviews/approves the Risk Management and Safety Review Plan and helps implement risk mitigations. Reviews/approves country selection; develops site selection criteria; contributes to site training materials. Primary contact for clinical protocol questions to external investigators and internal study team. Reviews/reports/manages protocol deviations; reviews patient-level and cumulative data per review plan. Reviews safety data and SAE reports; targeted and designated medical events; ensures clinical documents (e.g., ICD) are updated. Tracks/reconciles SAEs and presents data in Safety Review Team meetings. Ensures trial master file (TMF) compliance for clinical documents.
- Clinical Reporting: May contribute to clinical sections of regulatory filings (as required). May support responses to regulatory queries and Clinical Trial Applications (CTAs). Inputs/reviews the Clinical Study Report (including narratives) to support disclosure of safety/efficacy and trial conclusions; contributes to primary publication. Provides clinical support for audits/inspections.
Basic Qualifications
- Advanced degree or professional certification in a health care related, scientific, or technical discipline.
- Biopharmaceutical clinical research & development experience:
- BA/BS: 8+ years; MBA/MS: 7+ years; PhD/PharmD: 5+ years.
- Clinical research experience in phase 3/pivotal space.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical, administrative, and project management capabilities; excellent verbal and written English communication.
- Demonstrated experience establishing, managing, and training clinical development teams.
Preferred Qualifications
- Oncology experience highly preferred.
- Passion for helping patients.
- Proven analytical skills (large data sets).
- Effective communication/presentation/organization.
- Demonstrated scientific writing skills.
- Global perspective; experience working effectively in diverse teams and with internal/external partners and investigators/medical professionals.
- Solid understanding of related disciplines (clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance).
- Proficient with basic IT and telecommunications (voice/video).
- Ability to adapt to change while maintaining integrity/quality.
- Effective problem-solving/agile decision-making; collaborative leadership; foresight/judgment; proactive independent organization of tasks/time/priorities.
Job Responsibilities
- Leadership: Independently leads clinical execution of one or more medium–high complexity studies with significant business impact (may be accountable for program-level clinical deliverables). Contributes to continuous improvement/process enhancement and innovative approaches to maximize trial execution effectiveness. May provide matrix management support.
- Content Creation: Provides clinical input to support development of the protocol design document (PDD). Leads protocol development from the approved PDD to maximize operational efficiency, trial quality, and participant/site engagement while minimizing amendments and quality issues. Partners with the Global Development Lead in governance review/approval. 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 data collection tools; statistical analysis plan (SAP), tables/listings/figures (TLFs), and blinded data review (BDR). Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees (charters/contracts/provision of data and documentation of outcomes). Provides clinical input to the Integrated Quality Management Plan (IQMP) and reviews/approves the final document. Inputs to/reviews/approves the Risk Management and Safety Review Plan and helps implement risk mitigations. Reviews/approves country selection; develops site selection criteria; contributes to site training materials. Primary contact for clinical protocol questions to external investigators and internal study team. Reviews/reports/manages protocol deviations; reviews patient-level and cumulative data per review plan. Reviews safety data and SAE reports; targeted and designated medical events; ensures clinical documents (e.g., ICD) are updated. Tracks/reconciles SAEs and presents data in Safety Review Team meetings. Ensures trial master file (TMF) compliance for clinical documents.
- Clinical Reporting: May contribute to clinical sections of regulatory filings (as required). May support responses to regulatory queries and Clinical Trial Applications (CTAs). Inputs/reviews the Clinical Study Report (including narratives) to support disclosure of safety/efficacy and trial conclusions; contributes to primary publication. Provides clinical support for audits/inspections.
Basic Qualifications
- Advanced degree or professional certification in a health care related, scientific, or technical discipline.
- Biopharmaceutical clinical research & development experience:
- BA/BS: 8+ years; MBA/MS: 7+ years; PhD/PharmD: 5+ years.
- Clinical research experience in phase 3/pivotal space.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical, administrative, and project management capabilities; excellent verbal and written English communication.
- Demonstrated experience establishing, managing, and training clinical development teams.
Preferred Qualifications
- Oncology experience highly preferred.
- Passion for helping patients.
- Proven analytical skills (large data sets).
- Effective communication/presentation/organization.
- Demonstrated scientific writing skills.
- Global perspective; experience working effectively in diverse teams and with internal/external partners and investigators/medical professionals.
- Solid understanding of related disciplines (clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance).
- Proficient with basic IT and telecommunications (voice/video).
- Ability to adapt to change while maintaining integrity/quality.
- Effective problem-solving/agile decision-making; collaborative leadership; foresight/judgment; proactive independent organization of tasks/time/priorities.