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PFIZER INC Colorectal Cancer Melanoma Clinical in MIDDLETON, Wisconsin

JOB REQUIREMENTS: Role Summary This position will be responsible for vision strategy in colorectal cancer/melanoma and will lead agents within Oncology Clinical Development providing strategic and technical guidance, as well as coordination and support to Medical Monitors and non-MD clinicians in CD&O. Provides therapeutic area clinical expertise to a project(s) and maintains state of the art knowledge in Therapeutic Area. Provides oncology expertise to the project team to enable clinical interpretation of study data. Role Responsibilities Provide Clinical Development Leadership to Asset Teams: Technical: Scientific Expertise & Recognition: high impact publications, key external presentations, recognized as subject matter expert internally and sought out for advice. Contribution to Projects: Accountable to deliver 2 or 3 large studies - related to execution and ability to bring in time lines. Single point of contact for Clinical Development to Medicine Team Leader for one or more indications or assetChairs the Clinical Sub-Team. Leads design, implementation, and interpretation of part of the global clinical program (one or more indications) for a drug candidate to deliver a successful regulatory submission worldwide, working closely with the Clinical Development Leader. Ensures alignment of regional clinical development strategy with global strategies for the indications he or she is responsible for. Contributes to development strategy, by creating and updating the clinical development plan which should integrate well-designed studies with the most efficient use of budget and resources, and risk and quality assessment. Leads 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) under supervision of the Clinical Development Leader. Signs off clinical documents as required by internal Guidances/SOPs. Leads discussions with regulators and with the resolution of clinical queries from drug regulatory agencies; leads or contributes to writing and review 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... For full info follow application link. EEO & Employment Eligibility: 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 work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. ***** APPLICATION INSTRUCTIONS: Apply Online: