Pfizer
Director, Clinical Development Scientist (Non-MD)
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Director, Clinical Development Scientist (Non-MD)
role at
Pfizer .
Job Summary The Director, Clinical Development Scientist is accountable for the scientific integrity of the study and the well‑being of patients enrolled in one or more clinical trials. The role applies technical and clinical skills to ensure the design of efficient and high‑quality clinical trials, employing quantitative design principles and clinical best practices to deliver both clinical and operational excellence. This position requires effective execution of studies, close partnership with clinical and medical colleagues, clinical operations, and other functional lines, timely delivery of quality protocols, and support in interpreting and communicating clinical trial data.
Job Responsibilities
Autonomously lead clinical execution of one or more studies of medium‑to‑high complexity and significant business impact, with accountability for program‑level deliverables.
Provide clinical input to support development of the protocol design document (PDD) and subsequent protocols, ensuring efficiency, participant/site engagement, and minimal amendments.
Lead development of protocol amendments, Administrative Change Letters, and Dear Investigator Letters.
Provide clinical input to data collection tools, SAP, TLFs, and BDR.
Author and manage approval of Informed Consent Documents (ICDs) and respond to external stakeholder questions.
Contribute to the Integrated Quality Management Plan (IQMP) and review final documents.
Establish Data Monitoring Committees (DMCs) and endpoint adjudication committees, including charters, contracts, and necessary documentation.
Review and approve risk management and safety review plans, ensuring compliance with approved plans and collaborating on risk mitigations.
Review country selection, develop site selection criteria, and contribute to site training material delivery.
Serve as the primary contact with external investigators and internal study teams regarding clinical protocol aspects.
Review, report, and manage protocol deviations.
Review patient‑level and cumulative data as per the review plan across studies.
Review safety data, SAE reports, TME’s, DME’s, and update clinical documents as required.
Track and reconcile serious adverse events (SAEs) and lead presentation of data during Safety Review Team meetings.
Ensure Trial Master File (TMF) compliance for clinical documents.
Input and review the Clinical Study Report, supporting disclosure of safety and efficacy data, trial conclusions, and primary publication of results.
Provide clinical support for audits or inspections.
Participate in regulatory filings and responses, including pediatric investigative plans, investigator brochures, IND/NDA annual reports, and periodic safety updates.
Support development of responses to regulatory queries and audit/inspection findings.
Contribute to continuous improvement and innovative approaches to maximize clinical trial execution effectiveness.
Provide matrix management support to clinical colleagues as needed.
Basic Qualifications
Advanced degree or professional certification in a healthcare related, scientific or technical discipline.
5+ years of experience with a track record of success in biopharmaceutical clinical research and development.
Clinical research experience in phase 3/pivotal studies.
Extensive knowledge of clinical development, global and regional regulation, ICH‑GCP, and adverse event management.
Demonstrated clinical, administrative, and project‑management capabilities and excellent verbal and written communication skills in English.
Experience establishing, managing, and training teams in clinical development.
Preferred Qualifications
Cardiometabolic disease experience (e.g., cardiology, obesity, endocrinology, nephrology) highly preferred.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities, including influencing and collaborating with peers, developing and coaching others, and guiding the work of colleagues to achieve meaningful outcomes and business impact.
Non‑standard Work Schedule, Travel or Environment Requirements
Global travel may be required. This is a hybrid role requiring onsite work approximately 2.5 days per week with a requirement to live within commuting distance.
Salary and Benefits
The annual base salary ranges from $169,700.00 to $282,900.00. The position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of base salary and a share‑based long‑term incentive program. Comprehensive benefits include a 401(k) with matching contributions, paid vacation, holidays, personal days, caregiver/parental and medical leave, and health, prescription, dental and vision coverage.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers in accordance with federal and state transparency laws and regulations. If you are a licensed physician who incurs recruiting expenses reimbursed by Pfizer, your name, address and the payment amount may be reported to the government. Contact your Talent Acquisition representative for questions.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in employment for all employees and applicants, regardless of race, color, religion, sex, sexual orientation, age, gender identity, gender expression, national origin, disability, or veteran status. Pfizer complies with applicable nondiscrimination laws, work authorization requirements, and is an E‑Verify employer. This position requires permanent U.S. work authorization.
Pfizer endeavors to make its careers website accessible to all users. For accommodation requests related to the accessibility of the website, application process, or interviewing, email disabilityrecruitment@pfizer.com.
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Director, Clinical Development Scientist (Non-MD)
role at
Pfizer .
Job Summary The Director, Clinical Development Scientist is accountable for the scientific integrity of the study and the well‑being of patients enrolled in one or more clinical trials. The role applies technical and clinical skills to ensure the design of efficient and high‑quality clinical trials, employing quantitative design principles and clinical best practices to deliver both clinical and operational excellence. This position requires effective execution of studies, close partnership with clinical and medical colleagues, clinical operations, and other functional lines, timely delivery of quality protocols, and support in interpreting and communicating clinical trial data.
Job Responsibilities
Autonomously lead clinical execution of one or more studies of medium‑to‑high complexity and significant business impact, with accountability for program‑level deliverables.
Provide clinical input to support development of the protocol design document (PDD) and subsequent protocols, ensuring efficiency, participant/site engagement, and minimal amendments.
Lead development of protocol amendments, Administrative Change Letters, and Dear Investigator Letters.
Provide clinical input to data collection tools, SAP, TLFs, and BDR.
Author and manage approval of Informed Consent Documents (ICDs) and respond to external stakeholder questions.
Contribute to the Integrated Quality Management Plan (IQMP) and review final documents.
Establish Data Monitoring Committees (DMCs) and endpoint adjudication committees, including charters, contracts, and necessary documentation.
Review and approve risk management and safety review plans, ensuring compliance with approved plans and collaborating on risk mitigations.
Review country selection, develop site selection criteria, and contribute to site training material delivery.
Serve as the primary contact with external investigators and internal study teams regarding clinical protocol aspects.
Review, report, and manage protocol deviations.
Review patient‑level and cumulative data as per the review plan across studies.
Review safety data, SAE reports, TME’s, DME’s, and update clinical documents as required.
Track and reconcile serious adverse events (SAEs) and lead presentation of data during Safety Review Team meetings.
Ensure Trial Master File (TMF) compliance for clinical documents.
Input and review the Clinical Study Report, supporting disclosure of safety and efficacy data, trial conclusions, and primary publication of results.
Provide clinical support for audits or inspections.
Participate in regulatory filings and responses, including pediatric investigative plans, investigator brochures, IND/NDA annual reports, and periodic safety updates.
Support development of responses to regulatory queries and audit/inspection findings.
Contribute to continuous improvement and innovative approaches to maximize clinical trial execution effectiveness.
Provide matrix management support to clinical colleagues as needed.
Basic Qualifications
Advanced degree or professional certification in a healthcare related, scientific or technical discipline.
5+ years of experience with a track record of success in biopharmaceutical clinical research and development.
Clinical research experience in phase 3/pivotal studies.
Extensive knowledge of clinical development, global and regional regulation, ICH‑GCP, and adverse event management.
Demonstrated clinical, administrative, and project‑management capabilities and excellent verbal and written communication skills in English.
Experience establishing, managing, and training teams in clinical development.
Preferred Qualifications
Cardiometabolic disease experience (e.g., cardiology, obesity, endocrinology, nephrology) highly preferred.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities, including influencing and collaborating with peers, developing and coaching others, and guiding the work of colleagues to achieve meaningful outcomes and business impact.
Non‑standard Work Schedule, Travel or Environment Requirements
Global travel may be required. This is a hybrid role requiring onsite work approximately 2.5 days per week with a requirement to live within commuting distance.
Salary and Benefits
The annual base salary ranges from $169,700.00 to $282,900.00. The position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of base salary and a share‑based long‑term incentive program. Comprehensive benefits include a 401(k) with matching contributions, paid vacation, holidays, personal days, caregiver/parental and medical leave, and health, prescription, dental and vision coverage.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers in accordance with federal and state transparency laws and regulations. If you are a licensed physician who incurs recruiting expenses reimbursed by Pfizer, your name, address and the payment amount may be reported to the government. Contact your Talent Acquisition representative for questions.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in employment for all employees and applicants, regardless of race, color, religion, sex, sexual orientation, age, gender identity, gender expression, national origin, disability, or veteran status. Pfizer complies with applicable nondiscrimination laws, work authorization requirements, and is an E‑Verify employer. This position requires permanent U.S. work authorization.
Pfizer endeavors to make its careers website accessible to all users. For accommodation requests related to the accessibility of the website, application process, or interviewing, email disabilityrecruitment@pfizer.com.
#J-18808-Ljbffr