岗位职责:

Role Summary:

The Development China Clinician is responsible for high quality and timely delivery of one ormore interventional clinical trials for a Global Product Development /Pfizer Essential Health (PEH). They apply technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies (in partnership with Development Operations) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). They ensure compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues. The China Clinician may act as a site liaison and point of contact to expedite study start-up and conduct and to support clinical training, compliance and overall study quality.

Responsibilities:

ClinicalTrials

•Co-chairs clinical study team and works collaboratively with other study team members.

•Point of accountability to the BU for design, conduct, interpretation and reporting of one or more clinical studies (or elements of those studies).

•Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.

•Through application of Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD), ensures the most efficient clinical protocols are developed.

•Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.

•Proactive in authoring efficient protocols that minimize the likelihood of amendments. Identifies and assesses study risks to good clinical practices, subject rights/safety and data integrity throughout protocol development and study conduct; creates, implements and assesses effectiveness of mitigation plans.

•Provides clinical input to Study Team for monitoring guidelines, iqRAMP, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, Regional Medical Monitor - Medical Oversight Plan as needed (ultimately oversees work of Study Team).

•Contributes to CRO / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied (e.g. lab specifications).

•Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost effective manner.

•Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.

•Jointly accountable with study team for study enrollment and adherence to agreed timelines for study deliverables.

•Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities.

•Consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the China Clinical Program Lead or the Global Clinical Lead). For all studies, clinical safety review should be performed in consultation with a designated medically-qualified Medical Monitor.

•Responsible for identifying emerging safety trends and raising them forward for further discussion with the

•Clinical Program Lead and/or Global Clinical Lead; follows up with investigators for specific safety findings (e.g. SAEs).

•Reviews and manages protocol deviations.

•Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.

•Conducts clinical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.

•Responsible for clinical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions.

•Ensures narrative strategy for clinical trial(s) is consistent with program narrative strategy; writes (or oversees writing of) safety narratives.

•Assists in ensuring regulatory compliance for clinical trials and reporting.

•Contributes to primary publication of clinical trial results.

•May act as primary contact with external investigators and internal study team for questions relating to the clinical/medical aspects of the protocol.

•Responsible for keeping the Development China Clinical Program Lead and/or Global Clinical Lead informed of any critical issues relating to benefit:risk evaluation, or study delivery in line with agreed budget, timelines and quality.

•Presents to internal and external advisory committees (e.g. Technical Review Committee, advisory

•boards) on design of clinical trials and data from clinical trials.

Site Liaison Responsibilities (if applicable)

•The China Clinician may have site liaison responsibilities:

•Serve as clinical site liaison to support trial conduct through virtual meetings or teleconferences (as appropriate) and essential face-to-face contact, working directly with site staff. Maintain the ‘Face of

•Pfizer’ at each site. Create and maintain positive relationships and enthusiasm.

•Understand the work environment and key relationships at clinical sites, use analytical and influencing skills to improve communications and collaboration between key stakeholders.

•Ensure site staff have thorough understanding of protocol requirements (technical and logistic), partner with site staff and study team members to overcome feasibility barriers and operational obstacles and ensure successful subject recruitment/enrollment/retention, protocol compliance and clinical trial quality.

•Conduct frank discussions and set clear expectations for site performance and monitor site performance through metrics.

•Identify quality issues and discuss with Pfizer clinical/operations study team members so that corrective actions may be instituted. Escalate protocol-related issues requiring medical expertise to the RCSL or medically-qualified China Clinical Program Lead, if needed. Escalate operational issues to the appropriate operations study team member.

•Identify the need for and provide supportive coaching and/or training to site staff, as appropriate.

•Identify methods, techniques, key relationships and logistic approaches employed by most successful sites and translate/transfer these best practices to aspiring sites.

General

•Motivates and engages colleagues in an understanding of disease and commitment and excitement to an indication and mechanism.

•Coaches and mentors less experienced clinicians; may directly manage clinicians.

•Maintains and enhances knowledge in relevant disease area and/or technical area (e.g. pediatrics, regional clinical trials) and practice guidelines relevant to the regions in which clinical trials are being conducted.

•Interfaces with other Pfizer sites, other BUs and other functions to develop and share best practices, as appropriate.

•May organize expert panel, consultant or advisory board meetings to provide input to protocols, clinical plans or data analysis.

•Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.

•Assists in the development of publications, abstracts, and/or presentations.

•Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).

•Assists in discussions with regulators and with the resolution of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries.

•May support technical review of licensing opportunities, including due diligence activities.

•Ensures compliance with global and local training requirements and adherence to relevant global / local clinical and medical controlled documents (CMCDs).

•Contributes to (or leads) continuous improvement activities, and to education and training of clinical staff in areas of competence/experience.

任职要求:

Qualifications (Training, Education & Prior Experience):

•With Master or M.D. education background in oncology direction

•Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval), IO and GU experience is preferred.

•Practical experience in clinical trial strategies, methods and processes.

•Track record of design, oversight and interpretation of clinical studies. Previous leadership / management experience or training.