Pfizer Sr. Director, Head of CTM in Shanghai, China
Leads an engaged organization of clinical trial management professionals (clinical operations (clinical trial support, monitoring, study management), clinical project management; and, project planning), and leverages external providers to provide industry-leading program and study level operational support for Pfizer's clinical trials, with priority focus on Pfizer's China Portfolio of Pfizer- r un s tud ies
Partners with other senior leaders/executives in the Research and Business Units (global and country groups), to develop and execute a strategy to ensure successful delivery of Pfizer's Portfolio with priority focus on Pfizer's China Portfolio of Pfizer- r un s tud ies
Provides leadership and expertise in developing strategies to maximize Pfizer's China R&D Center (CRDC)'s value to the Pfizer enterprise, including WRD, Pfizer Medical and Pfizer China
Influences and contributes to Pfizer enterprise and WRD China/ Asia strategies Develops collaborative relationships with all key stakeholders
Reports to VP, General Manager of China R&D Center (CRDC), Head of Development China
Directly manages Monitoring Leads, Study Management Leads, Clinical Project Managers
Serves as a member of the CRDC Leadership Team
Partners with GPD functional lines, and other WRD and Platform Lines, Business Units (global and country groups), Pfizer China and Enabling Functions
Resources Managed (budget and FTEs):
Responsibility for CTM department internal FTEs (representing the full spectrum of clinical trial management disciplines), and oversight external CRO resources for CTM department
Responsible for operational oversight for active and planned clinical protocols
Partners with senior leaders in Pfizer's RU/ BU clinical development units and medical affairs groups to develop a portfolio of development projects/ clinical trials to achieve Pfizer's enterprise development goals in general, with a priority focus on enabling/ delivering robust new product and/ or indication registration/ introduction, as well as maximizing product lifecycle opportunities in China.
Develops an operational strategy to deliver Pfizer's China Portfolio (across the continuum from design through execution, monitoring, data analysis and reporting of clinical studies ) , including:Ensures robust operational feasibility assessments are rigorous, realistic and included as a part of clinical study planning and prior to the development of final clinical program timelinesDevelops and aligns on options for study execution model (e.g., internal vs. external resourcing) that are fit for purpose, maximize efficiency and are strategically aligned with RU/ BU clinical development unitsImplements initiatives to enable rapid, efficient, high-quality and cost-efficient clinical trial conduct
Manages clinical trial operations for a spectrum of clinical studies (e.g., interventional, non-interventional, pragmatic, post-marketing commitments), enabling rapid, efficient and high-quality Phase I to IV clinical trial execution.
Partner with RU/ BU clinical development units to ensure:
Effective transparency, control and predictability of study execution costs
On time operational delivery of clinical programs
Maintenance of acceptable levels of clinical trial quality and compliance
Manage external CRO partners/ providers to ensure reliable study execution Engage with other DC and GPD functions and partner lines, when appropriate, to deliver the portfolio while ensuring human research subject protection, knowledge sharing, global standardization and continuous improvement.
Ensures robust capabilities across the full spectrum of clinical trial management disciplines. For clinical operations to ensure robust operational and quality performance across studies and throughout the lifecycle of clinical studies (e.g., p rotocol feasibility and s ite s election ; s tudy s tart-up a ctivities ; r egulatory/ e thics committee / h ealth a uthority requirements; s tudy c onduct ; site management, m onitoring and follow up; investigational drug accountability and management; i nspection re adiness, c ompliance and a udit r espons ibilit ies ) For clinical project management to a) provide expert input into clinical plans, optimal operational execution and delivery of clinical studies, from study concept through reporting, submission and as needed regulatory defense activities ; b) manage overall clinical project (e.g., budget, cost , quality , resourcing, risk and timeline ), through oversight and matrix leadership of cross-functional/ multi-disciplinary study teams
Provides line management to a group of clinical trial management professionalsEnsure roles are filled with capable individualsEffectively manage performanceEnsure colleague engagementContribute to the career development and performance reviews of staff.
Leads the development and execution of CRDC's strategic agenda; and, in collaboration with the Global Product Development (GPD) Leadership Team members, develop and refine GPD Asia strategy, including influencing and supporting China/ Asia strategic initiatives driven by WRD Research Units (RUs) and Partner Lines, as well as Pfizer Medical and Business Units (BUs)
Training & Education Preferred:
Substantial training and experience in Clinical R&D and/ or Medical-related fields are expected.
Experience in clinical trial program design and oversight of clinical operations
Understanding of GCP and applicability to clinical development
Thorough understanding of local and international regulations applicable to clinical development
Experience in budgetary management and fiscal awareness at team and portfolio level
Advanced degree: PhD / MD or equivalent
Additional training and experience in strategic planning and management consulting are preferred.
Training in leadership skills, supervisory skills and management skills
Prior Experience Preferred
10 to 15 years experience in Pharmaceutical Development
5 years experience in clinical development and/ or operations, including experience and knowledge of external CROs
Strong strategic experience in developing or implementing new clinical operations paradigms
Experienced direct and matrix leader and manager
Skilled negotiator and influencer
Project/Portfolio management experience desired but not required
Experience managing contract research organizations desired but not required
A strategist with exceptional experience of success in leading strategy development and implementation
Participated in strategic planning for Asia, especially China, with comprehensive understanding of China business environment and R&D landscape.
Demonstrated strong business mindset; broad knowledge and perspective; ability to anticipate trends and paint credible pictures of future opportunities.
A successful networker who forged strong relationships and alliances at all levels with excellent stakeholder influencing skills
Proven ability to work across multi-disciplinary groups to ensure business strategies are well communicated and implemented.
Extensive experience with drug R&D, especially in clinical development or medical
History of success in navigating through complex organizational relationships (internal & external) to drive and manage changes in times of ambiguity.
A track record of leading and project managing multiple complex projects
Practical experience in clinical trial strategies, methods and processes; deep knowledge of clinical trial design
Good understanding of Phase I through Phase IV clinical and regulatory operations
Experienced line and people manager
Extensive global experience, especially Asia
Experience in leading (or membership of) a team responsible for clinical study conduct and delivery, am and other team leadership experience
N: Not Applicable - 不适用 (China)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.