Clinical Development Scientist (Senior Director)
Pfizer
5 hours ago
Remote friendly (Lake Forest, IL)
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/amendments and related documents (Protocol Administrative Change Letters, Dear Investigator Letters); contribute to study design.
- Represent study team in protocol governance; partner with Global Development Lead on study/disease strategy; support KOL/Health Authority interactions.
- Ensure informed consent documents and responses to Health Authority/IEC requests.
- Provide clinical guidance to SAP (tables/listings/figures), data collection strategy/instruments/data review plan; lead review of emerging clinical data, queries, and database lock support.
- Provide clinical guidance to safety review plans/narratives; review safety data, update clinical documents, track/reconcile SAEs, and lead safety discussions.
- Ensure risk management plan consistency; implement risk mitigations.
- Establish/manage External Data Monitoring and Adjudication Committees.
- Develop site selection criteria; ensure protocol training for sites; support investigator meetings and ongoing training.
- Primary clinical point of contact; manage clinical response development and documentation (e.g., FAQ).
- Ensure TMF compliance; manage protocol deviation sub-categories and trend reviews.
- Provide clinical input/review for Clinical Study Report; support audits/inspections and regulatory filings sections.
- Lead continuous improvement/process enhancement; may supervise/mentor others.
Basic Qualifications:
- PhD/PharmD or equivalent + 7 years; or MA/MS + 10 years; or BA/BS + 12 years clinical research experience in biopharma.
Preferred Qualifications/Skills:
- Cardiometabolic disease experience.
- Biopharma clinical research experience across design/start-up/conduct/close-out, regulatory submissions, inspections.
- Publications and strong knowledge of clinical development, ICH/GCP, global/regional regulation.
- Clinical, administrative, and project management; launch/manage/train teams; cross-functional leadership and communication.
Benefits/Compensation (explicitly stated):
- Annual base salary $214,900–$358,100; eligible for bonus (22.5% target) and long-term incentive; 401(k) match and retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
- Global travel may be required; hybrid (on-site ~2.5 days/week).
Application instructions: Not specified.
- Independently lead clinical execution of one or more studies; accountable for program-level clinical deliverables.
- Lead protocol development/amendments and related documents (Protocol Administrative Change Letters, Dear Investigator Letters); contribute to study design.
- Represent study team in protocol governance; partner with Global Development Lead on study/disease strategy; support KOL/Health Authority interactions.
- Ensure informed consent documents and responses to Health Authority/IEC requests.
- Provide clinical guidance to SAP (tables/listings/figures), data collection strategy/instruments/data review plan; lead review of emerging clinical data, queries, and database lock support.
- Provide clinical guidance to safety review plans/narratives; review safety data, update clinical documents, track/reconcile SAEs, and lead safety discussions.
- Ensure risk management plan consistency; implement risk mitigations.
- Establish/manage External Data Monitoring and Adjudication Committees.
- Develop site selection criteria; ensure protocol training for sites; support investigator meetings and ongoing training.
- Primary clinical point of contact; manage clinical response development and documentation (e.g., FAQ).
- Ensure TMF compliance; manage protocol deviation sub-categories and trend reviews.
- Provide clinical input/review for Clinical Study Report; support audits/inspections and regulatory filings sections.
- Lead continuous improvement/process enhancement; may supervise/mentor others.
Basic Qualifications:
- PhD/PharmD or equivalent + 7 years; or MA/MS + 10 years; or BA/BS + 12 years clinical research experience in biopharma.
Preferred Qualifications/Skills:
- Cardiometabolic disease experience.
- Biopharma clinical research experience across design/start-up/conduct/close-out, regulatory submissions, inspections.
- Publications and strong knowledge of clinical development, ICH/GCP, global/regional regulation.
- Clinical, administrative, and project management; launch/manage/train teams; cross-functional leadership and communication.
Benefits/Compensation (explicitly stated):
- Annual base salary $214,900–$358,100; eligible for bonus (22.5% target) and long-term incentive; 401(k) match and retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
- Global travel may be required; hybrid (on-site ~2.5 days/week).
Application instructions: Not specified.