Director, Clinical Development Scientist - monza-brianza - Pfizer

    Pfizer
    Pfizer monza-brianza

    1 giorno fa

    Descrizione

    Job Summary
    The Director, Clinical Development Scientist:

    • Is accountable for the scientific integrity of the study and the well-being of the 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.
    • Is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines. The Clinical Development Scientist is accountable for timely delivery of a quality protocol, clinical execution of one or more large and / or complex clinical 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
    • Will also be the primary contact with external investigators & the internal study team for questions relating to clinical aspects of the protocol and partners with/supports 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 leads clinical execution of one or more studies of medium - 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 and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with/supports the Global Development Lead in governance review and approval process.
    • Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
    • Provides clinical input to the development of data collection tools. 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). Review 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.
    • Inputs to, reviews and approves, Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc.) to develop and implement any 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 team for questions relating to clinical aspects of protocol
    • 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 (eg 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 TMF compliance for clinical documents
    • Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting 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, including providing support as needed to audit/inspection
    • May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and 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 / 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, 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 (ie; 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, 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.
    The annual base salary for this position ranges from \(176,600.00 to \)282, 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. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered 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 to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
    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 and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
    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.
    Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
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