MD Clinician Oncology

MD Clinician Oncology - Senior Director/ Director

Org Marketing Statement Pfizer Inc: Working together for a healthier world Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Role Description " The MD Clinician (MDC) is responsible for working collaboratively with the Clinical Team Leader (CTL) and members of the development team to establish the clinical development strategy for one or more compounds from lead development in discovery to Phase I-III clinical trials " The MD Clinician (MDC) is accountable for patient safety and provides medical guidance during the design, execution, and reporting for clinical studies " Clinical background in medical oncology is required and previous experience in the management of breast cancer is desirable Responsibilities Technical responsibilities " Participates in the formulation of clinical development plans, including selection of the proof of concept indication. In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine), is responsible for the design of cost-effective protocols and conduct of data review, analysis and interpretation " Responsible for trial design and supporting the final recommendations on the clinical development plan for one or more compounds, including review of the pre-clinical package after soliciting appropriate input, review and endorsement from key stakeholders for go / no-go development decision criteria " Accountable for safety across the study, including regular review of safety data (including but not limited to SAEs) and response to safety issues " Consistent with Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead or as delegated by the clinical leader. The specific components of safety data review are detailed in the Safety Data Review Guide - for Clinicians and SAF09 SOP. " In conjunction with the CTL, prepares strategy presentations, presents and discusses data at relevant team, governance, external consultant, KOL, and regulatory meetings " Authors clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR) " Participates in the development and delivery of protocol training for investigator site and Pfizer staff " Acts as clinical representative in in-licensing activities such as due diligence reviews and reports " As a key member of the project team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s) " In conjunction with the Study Clinician and Development Operations, or designee, is responsible for the on-time and within-budget execution of protocols " May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues Qualifications " Requires MD and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice or industry setting " Must have minimum three years relevant industry experience " Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences). " Demonstrated scientific productivity (publications, abstracts, etc.) " Proven scientific writing skills and good communication skills 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. *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Pfizer prefers that you apply to this job directly on their site