Pfizer
Sr. Manager, Clinical Development Scientist (Non-MD)
Pfizer, San Diego, California, United States, 92189
Sr. Manager, Clinical Development Scientist (Non-MD)
Job Summary (high-level responsibilities and responsibilities):
Accountable for the scientific integrity of the study and the well‑being of the patients enrolled in one or more clinical trials; applies technical and clinical skills to design efficient, high‑quality trials using quantitative design principles and clinical best practices.
Responsible for effective execution of studies and works closely with other clinical and medical colleagues, clinical operations, and other functional lines; accountable for timely delivery of a quality protocol and for the clinical execution of trials, supporting interpretation and communication of trial data.
Maintains compliance with internal and external standards, proactively mitigates risk, and manages emerging clinical issues through timely, diligent review of clinical data, safety, and protocol deviations.
Primary contact with external investigators and the internal study team for questions regarding the clinical aspects of the protocol, while partnering with or supporting the Global Development Lead regarding disease‑area strategy.
Job Responsibilities
Provides clinical input to support development of the protocol design document (PDD).
Leads or supports development of the protocol from the approved PDD, ensuring efficient protocols that maximize operational efficiency, trial quality, and participant/site engagement, and that minimize likelihood of amendments or quality issues.
Leads or supports development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Provides clinical input to the development of data collection tools and to the SAP, TLFs, and BDR.
Author and manages approval of Informed Consent Documents (ICDs), including responses to external stakeholder questions.
Provides clinical input to development of the Integrated Quality Management Plan (IQMP) and reviews and approves the final document.
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, data provision, and documentation of outcomes.
Inputs to, reviews and approves, the Risk Management and Safety Review Plan; ensures activities are conducted consistent with the plan and partners with key stakeholders to develop and implement risk mitigations.
Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
Serves as the primary contact with external investigators and internal study teams for clinical protocol questions.
Reviews, reports and manages protocol deviations.
Reviews patient‑level and cumulative data per the data review plan across one or more studies.
Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (e.g., ICDs) are updated as required; tracks and reconciles SAEs and leads presentation of data during Safety Review Team meetings.
Ensures TMF compliance for clinical documents.
Inputs and reviews the Clinical Study Report, including the review of narratives; supports disclosure of safety, efficacy data, and trial conclusions; contributes to primary publication of clinical trial results.
Provides clinical support during audits or inspections.
May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, regulatory‑authority responses).
May support development of responses to regulatory queries, audit/inspection findings, and Clinical Trial Applications (CTAs).
Contributes to continuous improvement, process enhancement, and innovative approaches to maximize effectiveness of trial execution.
Basic Qualifications
BA/BS or equivalent qualification with 6+ years of experience in the biopharmaceutical industry in clinical research and development.
MBA or MS equivalent with 5+ years of experience in the same area.
Advanced Degree with 1+ year of experience.
Demonstrated clinical, administrative, and project‑management capabilities, and excellent verbal and written communication skills in English, relating to individuals both inside and outside the organization.
Preferred Qualifications
Clinical research experience in Phase 3/pivotal studies highly preferred.
Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.) highly preferred.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management.
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 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 and Benefits The annual base salary for this position ranges from $135,100.00 to $225,100.00. The position is eligible for participation in the Global Performance Plan with a bonus target of 17.5% of the base salary and for the share‑based long‑term incentive program.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives, including a 401(k) plan with company match, paid vacation, holiday and personal days, paid caregiver/parental leave, medical, prescription drug, dental and vision coverage, as well as benefits available in the U.S. salary range (excluding Tampa, FL and non‑U.S. locations). Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. If you are a licensed physician who incurs recruiting expenses reimbursed by Pfizer, your name, address and the amount of payments made may be reported under the Sunshine Act.
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 expression, national origin, disability or veteran status. Pfizer complies with all applicable laws, uses E‑Verify, and requires permanent U.S. work authorization for this position.
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Accountable for the scientific integrity of the study and the well‑being of the patients enrolled in one or more clinical trials; applies technical and clinical skills to design efficient, high‑quality trials using quantitative design principles and clinical best practices.
Responsible for effective execution of studies and works closely with other clinical and medical colleagues, clinical operations, and other functional lines; accountable for timely delivery of a quality protocol and for the clinical execution of trials, supporting interpretation and communication of trial data.
Maintains compliance with internal and external standards, proactively mitigates risk, and manages emerging clinical issues through timely, diligent review of clinical data, safety, and protocol deviations.
Primary contact with external investigators and the internal study team for questions regarding the clinical aspects of the protocol, while partnering with or supporting the Global Development Lead regarding disease‑area strategy.
Job Responsibilities
Provides clinical input to support development of the protocol design document (PDD).
Leads or supports development of the protocol from the approved PDD, ensuring efficient protocols that maximize operational efficiency, trial quality, and participant/site engagement, and that minimize likelihood of amendments or quality issues.
Leads or supports development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Provides clinical input to the development of data collection tools and to the SAP, TLFs, and BDR.
Author and manages approval of Informed Consent Documents (ICDs), including responses to external stakeholder questions.
Provides clinical input to development of the Integrated Quality Management Plan (IQMP) and reviews and approves the final document.
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, data provision, and documentation of outcomes.
Inputs to, reviews and approves, the Risk Management and Safety Review Plan; ensures activities are conducted consistent with the plan and partners with key stakeholders to develop and implement risk mitigations.
Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
Serves as the primary contact with external investigators and internal study teams for clinical protocol questions.
Reviews, reports and manages protocol deviations.
Reviews patient‑level and cumulative data per the data review plan across one or more studies.
Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (e.g., ICDs) are updated as required; tracks and reconciles SAEs and leads presentation of data during Safety Review Team meetings.
Ensures TMF compliance for clinical documents.
Inputs and reviews the Clinical Study Report, including the review of narratives; supports disclosure of safety, efficacy data, and trial conclusions; contributes to primary publication of clinical trial results.
Provides clinical support during audits or inspections.
May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, regulatory‑authority responses).
May support development of responses to regulatory queries, audit/inspection findings, and Clinical Trial Applications (CTAs).
Contributes to continuous improvement, process enhancement, and innovative approaches to maximize effectiveness of trial execution.
Basic Qualifications
BA/BS or equivalent qualification with 6+ years of experience in the biopharmaceutical industry in clinical research and development.
MBA or MS equivalent with 5+ years of experience in the same area.
Advanced Degree with 1+ year of experience.
Demonstrated clinical, administrative, and project‑management capabilities, and excellent verbal and written communication skills in English, relating to individuals both inside and outside the organization.
Preferred Qualifications
Clinical research experience in Phase 3/pivotal studies highly preferred.
Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.) highly preferred.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management.
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 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 and Benefits The annual base salary for this position ranges from $135,100.00 to $225,100.00. The position is eligible for participation in the Global Performance Plan with a bonus target of 17.5% of the base salary and for the share‑based long‑term incentive program.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives, including a 401(k) plan with company match, paid vacation, holiday and personal days, paid caregiver/parental leave, medical, prescription drug, dental and vision coverage, as well as benefits available in the U.S. salary range (excluding Tampa, FL and non‑U.S. locations). Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. If you are a licensed physician who incurs recruiting expenses reimbursed by Pfizer, your name, address and the amount of payments made may be reported under the Sunshine Act.
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 expression, national origin, disability or veteran status. Pfizer complies with all applicable laws, uses E‑Verify, and requires permanent U.S. work authorization for this position.
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