Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
This position is accountable for driving the clinical development of one or more programs in the RCC Franchise.
As Global Clinical Lead (GCL), the candidate will:
• Exercise expertise and in-depth knowledge of clinical research to lead the development of the clinical strategy for the assigned project(s) with focus on innovative clinical trial design, medical execution, data interpretation, registration activities and innovative strategies to solve clinical issues.
• Provide experienced technical, procedural and managerial support to guide Clinical Scientists and other clinical staff members.
• Reports to Franchise Clinical lead, Oncology Clinical Development
• Budget: Through development of the clinical strategy, guides many key program investments
• Staff: Manages direct reports (Pfizer colleagues or contract staff)
• Matrix: Leads project Clinical Sub-Team
• Single point of contact for Clinical Development to the Franchise Clinical Lead/Asset Team Leader/Team Leader
• Chairs the program Clinical Sub-Team.
• Contributes to development strategy, by creating and updating the clinical development plan
• Leads design, implementation, and interpretation of the global clinical program for a drug candidate to deliver a successful regulatory submission worldwide (i.e. from POC to NDA, Regulatory Submission and Approval, i.e. confirmatory Phase 2, Phase 3, and interventional Phase 4 studies).
• Ensures alignment of regional clinical development strategy with global strategies, and oversees medical execution of regional studies for a development drug candidate.
• Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert)
• Leads or assists in discussions with regulators and with the resolution of clinical queries from drug regulatory agencies; leads or contributes to writing and reviewing responses to regulatory queries
• Provides clinical input in the preparation and execution of meetings with Health Authorities
• Maintains and enhances knowledge in relevant therapeutic or technical areas and in global regulations/guidelines
• Provides clinical strategy/input to product teams to support marketing and product enhancement/ differentiations efforts, as needed
• Creates and maintains a network with key opinion leaders
• May organize expert panel, consultant or advisory board meetings to provide input to clinical plans
• May present to senior management, governance committees and external audiences on the clinical aspects of compound development, including milestones, strategies and data, as appropriate
Prior Experience Preferred:
• At least five years experience in Oncology Drug Development in the pharmaceutical and/or biotechnology industry, with a special focus in Hematology
• At least 2 years in late development
• Proven track record of success in an Oncology Drug Development Team environment
• Drug development experience including familiarity with:
• Design & implementation of drug development projects
• Clinical study management and monitoring
• Clinical & regulatory processes
• Regulatory submissions
• Project/process management
• Budget / expense management
• Experience with Vendor Management
• Knowledge and success in managing drug projects & multiple clinical studies.
• Demonstrated knowledge of clinical development and regulatory submission processes and requirements
• Demonstrated ability to manage complex projects and processes
• Proven track record of effective project management of drug development or other projects in a highly matrixed environment.
Developing strategies and translating into executable tactical plans
• Anticipates future consequences and trends accurately.
• Creates strategies to drive near and long-term business growth.
• Demonstrates command of complex business challenges and executes strategies to address at local and regional level.
• Anticipates and proactively manages issues related to the delivery of the project goals
Initiating and Implementing Change
• Flexibility and Resilience
• Courage with Decisiveness to Act
• Problem Solving
• Positive approach, forward thinking, challenge the status quo
• Utilizes and encourages and shares innovative approaches to build and maintain a competitive advantage
• Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
• Develops a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performance
• Responds to changing situations and others’ ideas that differ from own positively and constructively
• Develops and implements short-term and mid-term goals and project plans to achieve goals based on higher level business drivers and strategies; eliminates obstacles to success
• Analyzes and solves problems to make effective decisions
• Consistently takes and encourages actions that are new, or that improve existing approaches and systems
• Has the personal and organizational confidence to communicate difficult messages promptly and in a suitable manner so that appropriate actions can be taken.
Matrix leadership skills
• Collaborative, supportive
• Networking and Alliance Building
• Personal Leadership
• Encourages contributions by generating commitment to and achievement of business objectives; serves as an advocate for others
• Lobbies key internal and external stakeholders to ensure success
• Looks for opportunities for collaboration and acts upon them
• Work with others to ensure close collaboration and support
• Works collaboratively with group members and contributes to positive intra- and inter-team relationships
• Manages a variety of personnel in a highly matrixed environment.
• Provides vision, direction and leadership to team members
• Drives and encourages conversations and proposals within teams and between lines that provide options to deliver the key decision points faster and more cost effectively with respect to the execution of the plan (e.g. pushing the limits of team effectiveness).
Decision Making Skills
• Advocate for a culture of “truth seeking” by encouraging candid dialogue, respectful debate and transparency of facts and assumptions to ensure high confidence in investment decisions
• Value the quality and clarity of the decision-making process, not just the outcome (i.e. recognize quality “no go” decisions as equally as “go” decisions)
• Proactively ensure full understanding of the potential risks and opportunities of investments – fully examine or articulate both the downside and the upside
• Engage in healthy dialogue and debate – ask the "tough" questions, provide the candid answers, and consider all points of view.
• Fully prepare to discuss the decision at hand (e.g. prepare or review background documents, pre-reads to ground and inform all decision makers)
Managing others / Managing performance
• Sets goals, revises goals as projects change and measures performance against those goals.
• Able to manage cross-functional teams and complex projects to deliver milestones according to set budgets/resources
• Provides timely feedback regarding performance
• Ensures the development of individuals with respect to both technical capabilities and personal effectiveness (as individuals and also as team members)
Equal Employment Opportunity
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 visas, 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 residency 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.