BioSpace, Inc.
Associate Medical Director/Medical Director, Medical Safety Evaluation, Translat
BioSpace, Inc., North Chicago, Illinois, us, 60086
Job Details
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
Purpose
Responsible for supporting Product Safety Leads (PSTLs)or serve as a PSTL under the supervision of the Group Medical Director to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation for one or more developmental products and during due diligence activities.
Responsibilities:
Understand and apply pharmacology, chemistry and non-clinical toxicology to effectively conduct safety assessments
Contribute to the authorship of key safety documents (such as the Investigators Brochure or Development Safety Update Report) for early development assets
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret pre-clinical and clinical safety data and communicate the analysis and interpretation to cross-functional teams
Conduct, summarize and communicate safety assessments in due diligence activities for Immunology
Key Stakeholders:
PST Lead, Search and Evaluation Team, Project Management, Regulatory Affairs, Discovery, Clinical Operations
Qualifications
Qualifications
MD / DO with 2+ years of residency with patient management experience (required)
Expertise in translational science and/or early research in immune mechanisms of disease, as demonstrated, for example, through a peer reviewed publication (preferred)
Effectively analyze pre-clinical and clinical data (required)
Background in bench or clinical research is a plus
Effectively write technical documents with direction
Work collaboratively in a team environment and be self-starting and able to work independently
Ability to effectively present recommendation / opinions in a group environment
Fluency, both written and oral, in English
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , and YouTube .
Stock Symbol:
ABBV
Stock Exchange:
NYSE
Company info Website http://www.abbvie.com/ Phone 1-800-255-5162 Location 1 North Waukegan Road North Chicago Illinois 60064 United States
Share this job
Facebook Twitter LinkedIn
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
Purpose
Responsible for supporting Product Safety Leads (PSTLs)or serve as a PSTL under the supervision of the Group Medical Director to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation for one or more developmental products and during due diligence activities.
Responsibilities:
Understand and apply pharmacology, chemistry and non-clinical toxicology to effectively conduct safety assessments
Contribute to the authorship of key safety documents (such as the Investigators Brochure or Development Safety Update Report) for early development assets
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret pre-clinical and clinical safety data and communicate the analysis and interpretation to cross-functional teams
Conduct, summarize and communicate safety assessments in due diligence activities for Immunology
Key Stakeholders:
PST Lead, Search and Evaluation Team, Project Management, Regulatory Affairs, Discovery, Clinical Operations
Qualifications
Qualifications
MD / DO with 2+ years of residency with patient management experience (required)
Expertise in translational science and/or early research in immune mechanisms of disease, as demonstrated, for example, through a peer reviewed publication (preferred)
Effectively analyze pre-clinical and clinical data (required)
Background in bench or clinical research is a plus
Effectively write technical documents with direction
Work collaboratively in a team environment and be self-starting and able to work independently
Ability to effectively present recommendation / opinions in a group environment
Fluency, both written and oral, in English
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , and YouTube .
Stock Symbol:
ABBV
Stock Exchange:
NYSE
Company info Website http://www.abbvie.com/ Phone 1-800-255-5162 Location 1 North Waukegan Road North Chicago Illinois 60064 United States
Share this job
Facebook Twitter LinkedIn