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CLINICAL RESEARCH PHYSICIAN

Company: ACS Solutions
Location: Princeton
Posted on: January 15, 2022

Job Description:

Position : CLINICAL RESEARCH PHYSICIAN Location : Princeton Pike, NJ - RemoteDuration : 6 Months ContractJob Description:Comments: The position is in immuno-oncology, with a focus on melanoma at least initially.The Clinical Research Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.The Clinical Research Physician:* Serves as a primary source of medical accountability and oversight for clinical trials* Matrix management responsibilities across the internal and external network* Manages Phase 1 - Phase 3 studies, with demonstrated decision making capabilities* Provides medical and scientific expertise to cross-functional colleaguesKey responsibilities include:Medical Monitoring* Conducts medical data review of trial data, including eligibility review* Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)* Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives* Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)* Fulfills GCP and compliance obligations for clinical conduct and maintains all required trainingClinical Development Expertise & Strategy* Provides oversight and medical accountability for a group of studies. Participates in review of clinical study reports (CSRs)* Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists* Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)* Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs* Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area by attending scientific conferences and ongoing review of the literature* Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape* Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and othersRequirements:* MD required (or ex-US equivalent)* 3 or more years of Industry experience and/or clinical trials experience is requiredJob Requirements:Position : CLINICAL RESEARCH PHYSICIAN Location : Princeton Pike, NJ - Remote Duration : 6 Months Contract Job Description: Comments: The position is in immuno-oncology, with a focus on melanoma at least initially. The Clinical Research Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. The Clinical Research Physician: --- Serves as a primary source of medical accountability and oversight for clinical trials --- Matrix management responsibilities across the internal and external network --- Manages Phase 1 - Phase 3 studies, with demonstrated decision making capabilities --- Provides medical and scientific expertise to cross-functional colleagues Key responsibilities include: Medical Monitoring --- Conducts medical data review of trial data, including eligibility review --- Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines) --- Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives --- Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations) --- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training Clinical Development Expertise & Strategy --- Provides oversight and medical accountability for a group of studies. Participates in review of clinical study reports (CSRs) --- Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists --- Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.) --- Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs --- Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area by attending scientific conferences and ongoing review of the literature --- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape --- Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others Requirements: --- MD required (or ex-US equivalent) --- 3 or more years of Industry experience and/or clinical trials experience is required

Keywords: ACS Solutions, Trenton , CLINICAL RESEARCH PHYSICIAN, Healthcare , Princeton, New Jersey

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