Global Clinical Lead, Oncology Clinical Development
Pfizer - La Jolla, CA

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Role DescriptionThis 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.Organizational Relationships: Reports to Franchise Clinical lead, Oncology Clinical DevelopmentResources Managed: Budget: Through development of the clinical strategy, guides many key program investmentsStaff: Manages direct reports (Pfizer colleagues or contract staff)Matrix: Leads project Clinical Sub-TeamResponsibilitiesSingle point of contact for Clinical Development to the Franchise Clinical Lead/Asset Team Leader/Team LeaderChairs the program Clinical Sub-Team.Contributes to development strategy, by creating and updating the clinical development planLeads 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 queriesProvides clinical input in the preparation and execution of meetings with Health AuthoritiesMaintains and enhances knowledge in relevant therapeutic or technical areas and in global regulations/guidelinesProvides clinical strategy/input to product teams to support marketing and product enhancement/ differentiations efforts, as neededCreates and maintains a network with key opinion leadersMay organize expert panel, consultant or advisory board meetings to provide input to clinical plansMay present to senior management, governance committees and external audiences on the clinical aspects of compound development, including milestones, strategies and data, as appropriateQualificationsEducation Required: MD degreePrior Experience Preferred: At least five years experience in Oncology Drug Development in the pharmaceutical and/or biotechnology industry, with a special focus in HematologyAt least 2 years in late developmentProven track record of success in an Oncology Drug Development Team environmentTechnical Competencies: Drug development experience including familiarity with: Design & implementation of drug development projectsClinical study management and monitoringClinical & regulatory processesRegulatory submissionsProject/process managementBudget / expense managementExperience with Vendor ManagementKnowledge and success in managing drug projects & multiple clinical studies.Demonstrated knowledge of clinical development and regulatory submission processes and requirementsDemonstrated ability to manage complex projects and processesProven track record of effective project management of drug development or other projects in a highly matrixed environment.Behavioral Competencies: Developing strategies and translating into executable tactical plansAnticipates 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 goalsInitiating and Implementing ChangeInnovationLearningFlexibility and ResilienceCourage with Decisiveness to ActProblem SolvingPositive approach, forward thinking, challenge the status quoUtilizes and encourages and shares innovative approaches to build and maintain a competitive advantageRespectfully challenges practices, decisions or ideas to uphold integrity and ethical standardsDevelops a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performanceResponds to changing situations and others’ ideas that differ from own positively and constructivelyDevelops 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 successAnalyzes and solves problems to make effective decisionsConsistently takes and encourages actions that are new, or that improve existing approaches and systemsHas the personal and organizational confidence to communicate difficult messages promptly and in a suitable manner so that appropriate actions can be taken.Matrix leadership skillsInfluencingCollaborative, supportiveNetworking and Alliance BuildingPersonal LeadershipTeamworkCommunicationEncourages contributions by generating commitment to and achievement of business objectives; serves as an advocate for othersLobbies key internal and external stakeholders to ensure successLooks for opportunities for collaboration and acts upon themWork with others to ensure close collaboration and supportWorks collaboratively with group members and contributes to positive intra- and inter-team relationshipsManages a variety of personnel in a highly matrixed environment.Provides vision, direction and leadership to team membersDrives 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 SkillsAdvocate for a culture of “truth seeking” by encouraging candid dialogue, respectful debate and transparency of facts and assumptions to ensure high confidence in investment decisionsValue 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 upsideEngage 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 performanceSets 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/resourcesProvides timely feedback regarding performanceEnsures the development of individuals with respect to both technical capabilities and personal effectiveness (as individuals and also as team members) - 5 months ago - save job - block
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