NJ Employer Senior Manager, Clinician, Biosimilars in Bridgewater, New Jersey

ROLE SUMMARYThe Clinician (Senior Manager) executes the Clinical Development Plan throughout the lifecycle of an asset, is responsible for scientific oversight, data integrity and scientific quality of the clinical trial(s) within the program.ROLE RESPONSIBILITIESThe Clinician leads execution of the Clinical Development Plan throughout the lifecycle of an asset. Is responsible for scientific oversight, data integrity and quality of the clinical trial(s) within the program.In close collaboration with the GCL, executes strategy decisions, presents and discusses data at relevant team, governance and other meetings, often taking the lead or functioning as delegate of the GCL.Is leading the trial design by authoring protocols and amendments, and leading the review and analyzes of emerging study data.Maintains a high degree of awareness of the external environment and ensures external innovations in scientific aspects and operational delivery are applied to the Research portfolio. Builds relationships with external investigators to promote scientific discussions, clinical execution and avid interest in Pfizer's success.Analyzes emerging safety profile of the drug, keeping the GCL and Safety lead (if applicable) informed of changes in the safety profile as they occur in the assigned study(ies). Fully knowledgeable about the safety profile of allocated drugs on which studies are being conducted, or which are called for in the protocol.Authors/contributes to clinical sections of regulatory briefing documents, clinical study reports and regulatory submissions; supporting member of the Rapid Response Team that's responding to queries from regulatory agencies.Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures. Volunteers to actively participate in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures.Occasional travel (10%); mostly national, rarely international.QUALIFICATIONSScience degree (PhD, PharmD, MD) and minimum of 3 year Clinical Research experience in industry/CROClinical Research experience in the phase 3/pivotal space, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspections and regulatory approval.Background in Oncology and/or Inflammation, ideally experience in clinical development of Biosimilars and monoclonal antibodies.Extensive understanding of related disciplines (development operations, safety, biostatistics, regulatory, pre-clinical, pharmacology, pharmaceutical sciences)Demonstrated scientific productivity via publications, posters, abstracts and/or presentations.Demonstrated scientific writing skills and excellent communication skills (written and spoken) in EnglishWORK LOCATIONPosition can be performed remotely, anywhere in the United StatesSunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact y