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Director / Senior Director, Clinical Protocol Management (Early or Late Development)

  • Job Role: Cancer Research/Oncology
  • Job Hours: Full-Time
  • Sector: Industry
  • Location: CA - California
  • Company:  Pfizer US
  • Salary: Salary commensurate with experience
  • Job reference: 83274
  • Posted Date: Saturday, October 31, 2009 1:30:33 PM
Responsibilities:
1. Developing and implementing an integrated vision of Clinical Protocol Management that enables Clinical Protocol Managers to provide maximal business value, culminating in high quality strategic and operational delivery and maximized cost efficiency.
2. Leads and directs clinical protocol managers to manage and execute clinical trials from First in Human through Phase IV.
3. Devise oncology-specific implementation methods for key activities and processes, i.e., Op Plan, Dev Plan, MIP, Risk Management, etc.
4. Creating oncology-specific systems & data standards for project management activities at study level
5. Support Portfolio Management with reporting, and ensuring data quality and validity; provide contextual interpretation of information to facilitate appropriate interpretation
6. Developing and implementing Clinical Protocol Management metrics to ensure focus on continuous improvement of project management methodology to optimize business value
7. Deliver quality of supervision, performance management, and personal development for clinical protocol management colleagues in oncology BU
8. Accountable for overall clinical trial resource (internal and external FTEs and costs) planning and forecasting
9. Directly manages and is accountable for the overall budget for clinical protocol management and clinical studies
10. Lead vendor selection process and accountable for providing the leadership and guidance for vendor management throughout the life-cycle of study conduct
11. Recruit, retain, and develop appropriate, qualified clinical protocol management staff for BU
12. Devise project management practices that are industry-leading and applicable across the broader organization
13. Partner with Oncology Operations leadership and governance to consistently enhance the effectiveness and efficiency of executions of oncology studies in the oncology business unit
14. Provide support to BU governance as needed to promote effective across functions partnerships.
15. Establishes and maintains effective interfaces among project management, clinical, partner lines, and vendors to support all clinical studies within BU
16. Responsible for leading resource management review and reporting for all studies and partner with Portfolio Manager for resources reporting.

Training & Education Required, and other Job Requirements:
Minimum requirements:
1. Bachelor’s degree, advanced degree is desirable in a discipline relevant to drug development or business. Professional project management certification is highly desirable.
2. 10 -15 years pharmaceutical industry, at least 5 of which are in leadership of or are direct clinical trial management activities.
3. Previous people management experience with strong understanding of the elements of drug development programs and project management
4. Credible Project Management expert, recognized internally and perhaps recognized externally for expertise in the profession

Prior Experience Preferred:
1. Extensive project and program management experience, particularly in oncology clinical development
2. Broad knowledge of project management and planning methodologies, principles, best practices, supporting systems, and tools
3. Direct management experience of clinical project managers (responsible for the execution of clinical studies) which will report into the position
4. Extensive knowledge of team development principles and successful implementation
5. Experience in evaluation and implementation of continuous improvement projects (Lean/Six Sigma)
6. Successful track record in the implementation and execution of clinical studies
7. Successful track record and experience in budgetary management and fiscal awareness
8. Demonstrated effective negotiating and influencing skills, good interpersonal, leadership, and team player skills
9. Record of achievement and delivery for personal and supervisee goals

Throughout our 153 years, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees. Pfizer wants to ensure that employees have resources to help them develop and succeed both in their careers and personal lives. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life.

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.

All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S.

For certain classes of temporary visa, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residence and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.

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