Pfizer Sr. Director, Head of China CDMM in Shanghai, China
Position Purpose The Head of China Data Monitoring & Management is responsible for leading the China Data Monitoring & Management , through management and supervision of Data Management (DM) and Technical Operations (Tech Ops) groups in China and oversight of vendors (CROs and FSPs) to whom these activities may be outsourced. This will include championing of the implementation and use of harmonized, consistent processes and excellence in CDMM deliverables related to cost effective, timely and high quality clinical study data, according to agreed global goals. The head of China Data Monitoring & Management proactively manages resources across the CDMM functions and ensures effective collaborations with the DMM TA's and sub-functions as well as GBDM functions at other sites in order to ensure consistent process, a high standard and full compliance to achieve optimal project deliverables. This role has ultimate accountability for end to end DMM deliverables on all trials allocated to the DMM China team including relevant resourcing, budgeting and planning.
DMM is a critical partner in the advancement of Pfizer's development pipeline, and the Head of China DMM leads an organization with a significant and broad impact on Pfizer's portfolio and overall position in the market. The Head of China DMM is also a key member of the DMM leadership team, and will play an instrumental role in creating and developing a brand new group that will become a major presence for DMM. The role requires experience in establishing and building a large research-focused organization, the development of strong working relationships with the other departmental functions to facilitate open lines of communication regarding project priorities, and strong technical experience with a comprehensive and expert understanding of Data Management, and a perspective on the field's future evolution. The Head will innovate and drive the global DMM future strategy aimed to position Pfizer DMM as best in class in the industry, to ensure the critical advancement of clinical drug candidates.
Resources Managed (budget and FTEs)
Manage direct reports (Data Management TA Leads and Tech Ops Lead) and an organization of up to 200.
Oversee vendors (CROs and FSPs) performing data processing, data management and study start up activities.
Determine headcount needs in conjunction with customers, GBDM Business Operations Head and Global Head of DMM.
Oversee vendors (CROs and partners) performing data processing, data management and study start up, study conduct and study close out activities
Determine headcount needs in conjunction with customers, Global DMM Head
Develop budgets and resourcing plans for China DMM activities, and contribute to similar efforts at Global level
Review annual individual objectives and development plans and perform periodic performance evaluation of direct reports following global or local corporate policy
Act as leader of China DMM across multiple programs and teams
Build a DMM departmental presence that has a strong local culture while being a fully integrated member of the worldwide DMM organization
Drive achievement of trial deliverables and submissions for DMM
Ensure strong partnerships within global DMM and Pfizer colleagues and with external vendors
Implement global clinical data monitoring and management practices and quality guidelines in compliance with regulatory requirements and Pfizer quality standards
Set current and future strategy as a core member of the DMM Leadership Team
Lead clinical and non-clinical special projects aimed to evolve DMM in line with the Pfizer organization and the changing landscape
Build and maintain strong and meaningful linkages with the regional/national Data Management community
Partner with Global Head to define organizational metrics and relevant Key Performance Indicators (KPIs) to drive a high performance organization
Drive, monitor and report on implementation of worldwide DMM initiatives and routine DMM deliverables
Ensure that all staff fully understand the requirements of the job and are clear regarding the DMM deliverables across the Pfizer portfolio.
Ensure development and implementation of site-specific change management based on worldwide strategies and standards; and in collaboration with other local functional heads.
Administer and manage the DMM group in terms of local HR issues, goals development, performance management, application of Pfizer policies / procedures and recruitment.
Ensure staff are qualified to perform their duties and complete training as required by the DMM curriculum
As requested, deputize for the responsibilities of the Global Head of DMM
Key Performance Indicators (Indicate how performance for this job will be measured)
Quality and timeliness of deliverables produced by assigned direct reports
Efficiency of resource usage
Adequacy of resource and estimation
Staff development and retention
Recruitment, retention and development of talent in organization
Technical Skill Requirements
Project management skills that can be used to facilitate efficient resource allocation and ensure adherence to timelines
Excellent verbal and written communication skills in relating to stakeholders and colleagues
Excellent English language skills, both verbal and written
Demonstrated ability to create clear written professional communications
Excellent knowledge of drug development
Knowledge of methodology of clinical trials and the data management discipline
Knowledge/experiences of quality control
Knowledge of ICH guidelines and regulatory requirements
Experiences of clinical study conduct operations (desirable)
Qualifications (i.e., preferred education, experience, attributes)
15 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency and at least 10 years in a leadership position. Understanding of biomedical data and analytics. Advanced degree is a plus.
Strong leadership capabilities including ability to drive strong following in reporting lines.
Experience with Clinical Trial Operations and a clear understanding of clinical data from internal as well as external sources
Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions
Demonstrated experience to manage complex projects and cross-functional teams including
delivering to project and portfolio metrics.
Demonstrated strong communication, interpersonal and negotiating skills in relating to colleagues and
associates internal/external to the organization and leveraging of those competencies to ensure
Strong track record of building successful relations with supervisors, peers, direct reports, suppliers,
customers, partners and stakeholders is essential
Strong strategic experience and business analytics ability to distill research needs and define
business, technical, and operational requirements
Expertise in globalizing functions to operate in a standardized fashion. Sound knowledge and
experience working across international boundaries and cultures. ____________________
Preferred Additional Experience
Previous experience leading a substantial group responsible for clinical data management and database management, or equivalent.
Leadership, project management, resource management (staff and financial), administrative and technical capabilities are required, as well as effective verbal and written communication. International experiences a plus.
Experience supporting the data management and database management components of regulatory submissions required.
Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.