Sr. Manager, Clinician (CNS)

Role Summary

The Development China Sr. Manager Clinician is responsible for high quality and timely delivery of one or more interventional clinical trials for a Global Product Development (GPD) or Vaccines Clinical Research and Development (VCRD). They may work as clinician representative in the asset team to provide the input on the asset development strategy and contribute to the strategy planning from program level. 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 CTM) 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.

Responsibility

General

• Contribute to the asset team on the clinical development strategy from the clinical / scientific perspective. Keep the close communication with GCLs to deliver the epi data, the specificity of Chinese patients’ population, the clinical practice and the unmet medical needs etc. in China, as well as to understand the global clinical update and the impact to China.

• Well understand the knowledge in relevant disease and technical area, the mechanism of asset and practice guidelines relevant to the regions in which clinical trials are being conducted.

• Motivates and engages colleagues in understanding of disease, the mechanism of asset and commitment to an indication.

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

• Leads in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, 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).

• Leads continuous improvement activities, and to education and training of clinical staff in areas of competence/experience.

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

• Coaches and mentors less experienced clinicians.

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

Clinical Trials

• Fully competent for below clinical trial related activities.

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

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

• Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, clinical pharmacologists, etc.), internal experts (e.g. clinical program lead, global clinical lead etc.), 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, statistical analysis plans, informed consent documents, safety review plan, data management plan, study monitoring plan (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).

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

• Ensures study is registered on www.ClinicalTrials.gov, study details are kept up-to-date and basic results are disclosed as required.

• Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings.

• 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.

• 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 Development China Category Lead/ 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 Category Lead/ 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. DC Technical Alignment Committee, advisory boards) on design of clinical trials and data from clinical trials.

2). 职位要求：

Education

• Required: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications in neurology or psychiatry background
• Preferred: Certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.)

Experience

• Required: ~3 years clinician experience in CNS products development; Proven track record of clinical trial relevant activities, including practical experience in study design, study preparation, and clinical trial execution.
• Preferred: Track record of practical experience in clinical development strategies and understanding of local / international regulations applicable to clinical trials (pre and post approval)..

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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