职位描述

职位描述： Role Summary:?The China Clinical Program Lead is responsible for high quality and timely delivery of interventional clinical trials for a clinical program (e.g. indication, formulation, regimen) as part of the overall global clinical program 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.??Depending on the program, the China Clinical Program Lead may manage a group of 1-10 study Clinicians, the majority of whom are MDs and/or hold postgraduate degrees in biomedical sciences (PhD, PharmD, DVM, etc.).Organizational Relationships:?Reports to Head of China Clinical Development?Collaborates with Medical, Statistics, Clinical Pharmacology, Portfolio and Project Management, Development Operations, Pharmaceutical Sciences, Safety, Regulatory etc.).Resources Managed (budget and FTEs):?Depending on the program, the China Clinical Program Lead may manage a group of 1-10 study Clinicians, the majority of whom are MDs and/or hold postgraduate degrees in biomedical sciences (PhD, PharmD, DVM, etc.).Responsibilities:?Leads China clinical development strategy and delivery, as part of global development.?Ensures that clinical trials for their program are designed and executed to the highest scientific and quality standards, and are focused on addressing the relevant technical and/or business objectives.?Accountable for negotiating milestones and ensuring delivery of clinical trials in line with agreed timelines.?Identifies and assesses program risks; creates, implements and assesses effectiveness of mitigation plans.?As delegated by the Head of China Clinical Development, may lead development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk 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 Head of China Clinical Developmentand/or medical monitor as appropriate.?In collaboration with Head of China Clinical Development and China Clinical Development colleagues, contributes to clinical preparation for and attends meetings with regulatory agencies and the resolution of clinical queries from drug regulatory agencies.?Maintains disease area knowledge relevant to their program, in particular with regards to design and outcome of clinical trials for competitors. This may include responsibilities for clinical expert panel meetings and advisory boards to give input on clinical plans.?Responsible for operational excellence and timely production and approval of quality clinical deliverables for their program, including protocols, study reports, contributions to the clinical plan and regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR), and manuscripts intended for external publication. The China Clinical Program Lead provides final sign off for documents generated by Study Clinician(s) when supervising their activities.?Through effective collaboration with colleagues in relevant Global Clinical function, ensures appropriate medical and scientific expertise from different countries and regions is consistently brought to all clinical program strategy, design, execution and interpretation activities.?Involves internal experts and consults with relevant technical advisory committee(s) to ensure high quality protocol designs and efficient clinical development plans that reflect Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD) principles, current disease area knowledge, and incorporation of all relevant elements of the Understand and Deliver decision-making framework for their program.?Provides clinical leadership on Phase 3b/4 programs regarding Scientific and Commercialization Support (SCS), co-promotion, product defense and clinical consultation on Epidemiology and Outcomes Research studies.?Maintains a productive, collaborative relationship with a broad group of internal stakeholders (e.g. Medical, Statistics, Clinical Pharmacology, Portfolio and Project Management, Development Operations, Pharmaceutical Sciences, Safety, Regulatory etc.).?Plans resources required for elements of program under his/her responsibility, in order to accomplish the clinical objectives in a timely and resource-efficient fashion.?Responsible for the development, retention and engagement of clinical colleagues reporting to them.?Ensures technical excellence and functional competency of Study Clinicians who report to them, through oversight, coaching, mentoring, performance management and training.?Keeps Head of China Clinical Development informed of clinical progress and any critical clinical issues, especially those impacting the emerging benefit:risk profile.?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) assigned to them and to the clinical colleagues reporting to them.?May present to senior management, governance committees and external audiences on the clinical aspects of compound development, including milestones, strategies and data, as appropriate.?Contributes to (or leads) continuous improvement activities, and to education and training of clinical staff in areas of competence/experience.Technical / Behavioral Competencies:?Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer.?Track record of achievement in clinical development, with a preference for exposure in disease area of relevance; able to independently formulate and execute clinical development or lifecycle strategy.?Demonstrated potential or ability to design, initiate and conduct clinical studies as part of an integrated clinical plan.?Able to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents.?Proven scientific writing skills, with strong interpersonal, written/verbal communication skills, including ability to evaluate, interpret and present complex data.?Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets; sets priorities; able to define and manage appropriate resource requirements (budgets and FTEs) both in-house and vendors / contractors.?Able to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders?Collaborative problem solving (handles conflict constructively).?Creativity and/or ability to put innovative approaches into practice in clinical development.?Able to embody Pfizer leader behaviors and the OWN-IT culture.Qualifications (Training, Education & Prior Experience):Education?Required: M.D., Ph.D., D.V.M., M.S., and/or PharmD or equivalent qualifications.?Preferred: Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).Experience?Required: Proven track record of being a successful Study Clinician (preferably in late phase development, or post-approval, as applicable to role).?Preferred: Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval). Experience in pharmaceutical industry as people manager of clinical colleagues. 职能类别： 医药技术研发管理人员

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