Director, Clinical Development Scientist (Non-MD)

Director, Clinical Development Scientist (Non-MD)

Job Summary

• Accountable for the scientific integrity of clinical studies and the well‑being of patients enrolled in one or more clinical trials. Applies technical and clinical skills to design efficient, high‑quality trials using quantitative principles and best clinical practices.
• Responsible for effective execution of studies in close partnership with clinical, medical, operations and other functional lines. Delivers quality protocols and clinical execution of large or complex trials while supporting interpretation and communication of trial data.
• Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues through timely review of clinical data, safety and protocol deviations.
• Primary contact with external investigators and the internal study team for questions related to clinical aspects of the protocol. Partners with the Global Development Lead regarding study and disease area strategy.
• May provide matrix management support of one or more IM clinicians on one or more clinical studies or across a clinical program.

Job Responsibilities

• Autonomously leads clinical execution of one or more studies of medium to high complexity and significant business impact. May be accountable for program‑level clinical deliverables.
• Provides clinical input to support development of the protocol design document (PDD).
• Leads development of the protocol from the approved PDD, ensuring efficient protocols that maximize operational efficiency, trial quality and participant/site engagement while minimizing the likelihood of amendments or quality issues.
• Leads development of protocol amendments, Protocol Administrative Change Letters and Dear Investigator Letters.
• Provides clinical input to the development of data collection tools and is responsible for providing clinical input to SAP, TLFs and BDR.
• Authors 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). Reviews and approves final document.
• Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
• 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., ICD) are updated as required.
• Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
• Ensures clinical document TMF compliance.
• Provides clinical support to the study team or clinical program in response to audits or inspections.
• May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports and Regulatory authority responses) if required.
• May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs).
• Contributes to continuous improvement and process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.

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, in relating to individuals both inside and outside Pfizer.
• Demonstrated experience establishing, managing, and training teams in clinical development.

Preferred Qualifications

• Cardiometabolic Disease experience highly preferred (cardiology, obesity endocrinology, nephrology, etc).

Non‑standard Work Schedule, Travel Or Environment Requirements

Global travel may be required.

Key Compensation and Benefits

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. Pfizer offers comprehensive benefits including 401(k) plan with matching contributions, 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, and 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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