Clinical Development Scientist (Senior Director)
Pfizer
17 days ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
Job Responsibilities
- Independently lead clinical execution of one or more studies; accountable for program-level clinical deliverables.
- Lead protocol development and amendments (including Protocol Administrative Change Letters and Dear Investigator Letters); represent study team in protocol governance.
- Ensure informed consent documents and responses to Health Authority/IEC requests.
- Provide clinical guidance for SAP and TLFs (tables, listings, figures).
- Set and lead clinical data collection/review strategy; review/query data; present data and support database lock.
- Guide safety review planning; track/reconcile SAEs; lead clinical safety discussions; update safety documents.
- Guide risk management plan implementation and risk mitigations.
- Establish/manage External Data Monitoring Committees and Adjudication Committees.
- Develop site selection criteria; ensure protocol training and investigator meeting/training delivery.
- Serve as primary clinical point of contact; manage clinical responses (e.g., FAQs).
- Ensure protocol deviation categorization/reporting and reconciliation; review deviation trends.
- Ensure TMF compliance; provide input/review of Clinical Study Report; support audits/inspections.
- Provide clinical input to regulatory filings; lead continuous improvement/process enhancement.
Basic Qualifications
- PhD/PharmD or equivalent with 7+ years; or MA/MS with 10+ years; or BA/BS with 12+ years clinical research experience (biopharma).
Preferred Qualifications / Skills
- Cardiometabolic disease experience; biopharma clinical research across design/start-up/conduct/close-out (incl. regulatory submissions/inspections).
- ICH/GCP knowledge; clinical/admin/project management and strong communication.
- Experience launching/managing/training clinical teams; demonstrated leadership and ability to manage cross-functional teams and complex projects.
Benefits / Compensation (as stated)
- Annual base salary: $214,900–$358,100; bonus target 22.5% (Global Performance Plan); 401(k) with matching and additional retirement contribution; paid leave and health benefits (medical, dental, vision).
Relocation support may be available (business need/eligibility).
- Independently lead clinical execution of one or more studies; accountable for program-level clinical deliverables.
- Lead protocol development and amendments (including Protocol Administrative Change Letters and Dear Investigator Letters); represent study team in protocol governance.
- Ensure informed consent documents and responses to Health Authority/IEC requests.
- Provide clinical guidance for SAP and TLFs (tables, listings, figures).
- Set and lead clinical data collection/review strategy; review/query data; present data and support database lock.
- Guide safety review planning; track/reconcile SAEs; lead clinical safety discussions; update safety documents.
- Guide risk management plan implementation and risk mitigations.
- Establish/manage External Data Monitoring Committees and Adjudication Committees.
- Develop site selection criteria; ensure protocol training and investigator meeting/training delivery.
- Serve as primary clinical point of contact; manage clinical responses (e.g., FAQs).
- Ensure protocol deviation categorization/reporting and reconciliation; review deviation trends.
- Ensure TMF compliance; provide input/review of Clinical Study Report; support audits/inspections.
- Provide clinical input to regulatory filings; lead continuous improvement/process enhancement.
Basic Qualifications
- PhD/PharmD or equivalent with 7+ years; or MA/MS with 10+ years; or BA/BS with 12+ years clinical research experience (biopharma).
Preferred Qualifications / Skills
- Cardiometabolic disease experience; biopharma clinical research across design/start-up/conduct/close-out (incl. regulatory submissions/inspections).
- ICH/GCP knowledge; clinical/admin/project management and strong communication.
- Experience launching/managing/training clinical teams; demonstrated leadership and ability to manage cross-functional teams and complex projects.
Benefits / Compensation (as stated)
- Annual base salary: $214,900–$358,100; bonus target 22.5% (Global Performance Plan); 401(k) with matching and additional retirement contribution; paid leave and health benefits (medical, dental, vision).
Relocation support may be available (business need/eligibility).