Clinical Development Scientist (Senior Director)
Pfizer
17 days ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Job Responsibilities:
- Independently lead clinical execution of one or more studies; accountable for program-level clinical deliverables.
- Contribute to protocol development (including amendments, Protocol Administrative Change Letters, Dear Investigator Letters) and represent study team in internal review governance.
- Ensure informed consent documents and responses to Health Authority/IEC requests.
- Provide clinical guidance to SAP, and to clinical data collection strategy, instruments, and data review plan; set clinical data review strategy, review/query data, present findings, and ensure clinical queries are resolved for database lock.
- Provide clinical guidance to safety plans (Safety Review Plan/Narrative); review safety data, reconcile SAEs, lead safety discussions with MQI(s), and review safety narratives.
- Guide Risk Management Plan implementation; establish/manage External Data Monitoring and Adjudication Committees.
- Develop site selection criteria, support protocol training, and plan/deliver investigator and ongoing protocol training.
- Serve as primary clinical point of contact for protocol questions; manage clinical response development/curation.
- Manage protocol deviations (categorization, reporting, reconciliation, trend review) and ensure TMF compliance.
- Provide clinical input/review of Clinical Study Report; support audits/inspections and regulatory submissions; support disclosure and may contribute to publications.
- Lead continuous improvement for clinical trial execution; may supervise/mentor others.
Basic Qualifications:
- PhD/PharmD (or equivalent) +7 years; or MA/MS +10 years; or BA/BS +12 years clinical research in biopharma.
Preferred Qualifications:
- Cardiometabolic disease experience; biopharma clinical research across design/start-up/conduct/close-out including regulatory submissions/inspections; clinical development/regulation/ICH-GCP knowledge; leadership/team training experience; publication record.
Benefits/Comp:
- Annual base salary $214,900–$358,100; bonus target 22.5%; 401(k) match and retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision; relocation assistance may be available.
- Independently lead clinical execution of one or more studies; accountable for program-level clinical deliverables.
- Contribute to protocol development (including amendments, Protocol Administrative Change Letters, Dear Investigator Letters) and represent study team in internal review governance.
- Ensure informed consent documents and responses to Health Authority/IEC requests.
- Provide clinical guidance to SAP, and to clinical data collection strategy, instruments, and data review plan; set clinical data review strategy, review/query data, present findings, and ensure clinical queries are resolved for database lock.
- Provide clinical guidance to safety plans (Safety Review Plan/Narrative); review safety data, reconcile SAEs, lead safety discussions with MQI(s), and review safety narratives.
- Guide Risk Management Plan implementation; establish/manage External Data Monitoring and Adjudication Committees.
- Develop site selection criteria, support protocol training, and plan/deliver investigator and ongoing protocol training.
- Serve as primary clinical point of contact for protocol questions; manage clinical response development/curation.
- Manage protocol deviations (categorization, reporting, reconciliation, trend review) and ensure TMF compliance.
- Provide clinical input/review of Clinical Study Report; support audits/inspections and regulatory submissions; support disclosure and may contribute to publications.
- Lead continuous improvement for clinical trial execution; may supervise/mentor others.
Basic Qualifications:
- PhD/PharmD (or equivalent) +7 years; or MA/MS +10 years; or BA/BS +12 years clinical research in biopharma.
Preferred Qualifications:
- Cardiometabolic disease experience; biopharma clinical research across design/start-up/conduct/close-out including regulatory submissions/inspections; clinical development/regulation/ICH-GCP knowledge; leadership/team training experience; publication record.
Benefits/Comp:
- Annual base salary $214,900–$358,100; bonus target 22.5%; 401(k) match and retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision; relocation assistance may be available.