Sr. Manager, Clinical Development Scientist

Sr. Manager, Clinical Development Scientist (Non‑MD) Join to apply for the Sr. Manager, Clinical Development Scientist (Non‑MD) role at Pfizer . Job Summary Accountable for the scientific integrity of the study and the well‑being of the patients enrolled in one or more clinical trials, applying technical and clinical skills to design efficient and high‑quality trials. Responsible for effective execution of studies and works in close partnership with clinical and medical colleagues, clinical operations, and other functional lines to deliver a quality protocol and support data interpretation. 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 relating to clinical aspects of the protocol and partners with the Global Development Lead on study 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 while minimizing the 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 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 the final document. Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, and provision of relevant data and documentation of outcomes. Inputs, reviews and approves the Risk Management and Safety Review Plan; 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 the internal study team 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., ICD) are updated as required; tracks and reconciles serious adverse events across a study and leads presentation of data during Safety Review Team meetings. Ensures Trial Master File compliance for clinical documents. Inputs and reviews the Clinical Study Report including narratives; supports disclosure of safety and efficacy data and trial conclusions; contributes to primary publication of clinical trial results. Provides clinical support to the study team or clinical program in response to audits or inspections. May contribute to clinical sections of regulatory filings (e.g., Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, and regulatory authority responses) if required. May support responsible colleagues with development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs). Contributes to continuous improvement, process enhancement activities and innovative approaches to maximize effectiveness of clinical 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. Advanced Degree with 1+ years of experience. Demonstrated clinical, administrative, and project management capabilities, and excellent verbal and written communication skills in English. Preferred Qualifications Clinical research experience in phase 3/pivotal space highly preferred. Cardiometabolic disease experience highly preferred (e.g., cardiology, obesity, endocrinology, nephrology). Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, 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, 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. This is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week. The annual base salary ranges from $135,100.00 to $225,100.00. Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share‑based long‑term incentive program. Comprehensive benefits include a 401(k) plan with Pfizer matching and additional retirement contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and medical, prescription drug, dental and vision coverage. 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, you may be subject to reporting under the Sunshine Act. EEO & Employment Eligibility Pfizer is committed to equal opportunity 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 nondiscrimination laws and work‑authorization requirements. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. For accessibility assistance, contact (used solely for accommodation requests). Seniority level: AssociateEmployment type: Full‑timeJob function: Health Care ProviderIndustry: Pharmaceutical Manufacturing Get notified about new Clinical Development Manager jobs in Milan, Lombardy, Italy. #J-18808-Ljbffr