Pfizer
Director, Clinical Development Scientist (Non-MD)
Pfizer, San Diego, California, United States, 92189
Director, Clinical Development Scientist (Non-MD)
Job Summary
Accountable for the scientific integrity of the study and the well‑being of patients enrolled in one or more clinical trials. Applies technical and clinical skills to ensure the design of efficient, high‑quality clinical trials, employing quantitative design principles and clinical best practices to deliver both clinical and operational excellence.
Responsible for effective execution of studies and works in close partnership with clinical and medical colleagues, clinical operations, and other functional lines. Accountable for timely delivery of a quality protocol, clinical execution of large and/or complex trials, and supports appropriate interpretation and communication of clinical trial data.
Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety and protocol deviation review.
Primary contact with external investigators and the internal study team for questions relating to clinical aspects of the protocol and partners with the Global Development Lead regarding study and disease area strategy.
May also provide matrix management support of one or more IM clinicians on one or more clinical studies or across a clinical program.
Job Responsibilities
Autonomously and independently lead clinical execution of one or more studies of medium‑high complexity and significant business impact.
Provide clinical input to support development of the protocol design document (PDD).
Lead development of the protocol from the approved PDD, ensuring efficient protocols that maximize operational efficiency, trial quality and participant/site engagement.
Lead development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Provide clinical input to the development of data collection tools. Responsible for providing clinical input to SAP, TLFs and BDR.
Author and manage approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
Provide clinical input to development of the Integrated Quality Management Plan (IQMP) and review/approve final document.
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
Input to, review and approve Risk Management and Safety Review Plan. Ensure activities are conducted consistent with the approved plan.
Review and approve country selection, develop site selection criteria, and contribute to authoring and delivery of site training materials.
Serve as the primary contact with external investigators and internal study team for questions relating to clinical aspects of the protocol.
Review, report and manage protocol deviations.
Review patient‑level and cumulative data per the data review plan across one or more studies.
Review safety data, SAE reports, TME’s, DME’s and ensure clinical documents (e.g., ICD) are updated as required.
Track and reconcile serious adverse events (SAEs) across a study and lead presentation of data during Safety Review Team meetings.
Ensure TMF compliance for clinical documents.
Input and review the Clinical Study Report, including the review of narratives. Support disclosure of safety and efficacy data and trial conclusions. Contribute to primary publication of clinical trial results.
Provide clinical support to the study team or clinical program in response to audits or inspections.
May contribute to clinical sections of regulatory filings and responses to regulatory queries.
May support development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs).
Contribute to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
May provide matrix management support to one or more clinical colleagues.
Basic Qualifications
Advanced degree or professional certification in a health‑care related, scientific or technical discipline required.
5+ years of experience and track record of success in biopharmaceutical industry in clinical research and development.
Clinical research experience in phase 3/pivotal space.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
Demonstrated clinical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English.
Demonstrated experience establishing, managing, and training teams in clinical development.
Preferred Qualifications
Cardiometabolic Disease experience highly preferred (e.g., cardiology, obesity endocrinology, nephrology, etc.).
Candidate demonstrates a breadth of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, and oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Non‑standard Work Schedule, Travel or Environment Requirements Global travel may be required.
Work Location Assignment This is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week.
Compensation The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share‑based long‑term incentive program. Benefits include a 401(k) plan with Pfizer matching contributions and an additional Pfizer retirement savings contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental and vision coverage).
EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment, as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E‑Verify employer. This position requires permanent work authorization in the United States.
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Accountable for the scientific integrity of the study and the well‑being of patients enrolled in one or more clinical trials. Applies technical and clinical skills to ensure the design of efficient, high‑quality clinical trials, employing quantitative design principles and clinical best practices to deliver both clinical and operational excellence.
Responsible for effective execution of studies and works in close partnership with clinical and medical colleagues, clinical operations, and other functional lines. Accountable for timely delivery of a quality protocol, clinical execution of large and/or complex trials, and supports appropriate interpretation and communication of clinical trial data.
Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety and protocol deviation review.
Primary contact with external investigators and the internal study team for questions relating to clinical aspects of the protocol and partners with the Global Development Lead regarding study and disease area strategy.
May also provide matrix management support of one or more IM clinicians on one or more clinical studies or across a clinical program.
Job Responsibilities
Autonomously and independently lead clinical execution of one or more studies of medium‑high complexity and significant business impact.
Provide clinical input to support development of the protocol design document (PDD).
Lead development of the protocol from the approved PDD, ensuring efficient protocols that maximize operational efficiency, trial quality and participant/site engagement.
Lead development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Provide clinical input to the development of data collection tools. Responsible for providing clinical input to SAP, TLFs and BDR.
Author and manage approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
Provide clinical input to development of the Integrated Quality Management Plan (IQMP) and review/approve final document.
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
Input to, review and approve Risk Management and Safety Review Plan. Ensure activities are conducted consistent with the approved plan.
Review and approve country selection, develop site selection criteria, and contribute to authoring and delivery of site training materials.
Serve as the primary contact with external investigators and internal study team for questions relating to clinical aspects of the protocol.
Review, report and manage protocol deviations.
Review patient‑level and cumulative data per the data review plan across one or more studies.
Review safety data, SAE reports, TME’s, DME’s and ensure clinical documents (e.g., ICD) are updated as required.
Track and reconcile serious adverse events (SAEs) across a study and lead presentation of data during Safety Review Team meetings.
Ensure TMF compliance for clinical documents.
Input and review the Clinical Study Report, including the review of narratives. Support disclosure of safety and efficacy data and trial conclusions. Contribute to primary publication of clinical trial results.
Provide clinical support to the study team or clinical program in response to audits or inspections.
May contribute to clinical sections of regulatory filings and responses to regulatory queries.
May support development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs).
Contribute to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
May provide matrix management support to one or more clinical colleagues.
Basic Qualifications
Advanced degree or professional certification in a health‑care related, scientific or technical discipline required.
5+ years of experience and track record of success in biopharmaceutical industry in clinical research and development.
Clinical research experience in phase 3/pivotal space.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
Demonstrated clinical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English.
Demonstrated experience establishing, managing, and training teams in clinical development.
Preferred Qualifications
Cardiometabolic Disease experience highly preferred (e.g., cardiology, obesity endocrinology, nephrology, etc.).
Candidate demonstrates a breadth of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, and oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Non‑standard Work Schedule, Travel or Environment Requirements Global travel may be required.
Work Location Assignment This is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week.
Compensation The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share‑based long‑term incentive program. Benefits include a 401(k) plan with Pfizer matching contributions and an additional Pfizer retirement savings contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental and vision coverage).
EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment, as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E‑Verify employer. This position requires permanent work authorization in the United States.
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