BioSpace
Overview
Group Medical Director role at BioSpace (AbbVie). Responsibilities
Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc) Asset strategy lead safety representatives for larger programs (late stage) Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery Work closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA Lead and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA Proactively seek to understand why a safety concern or risk emerges and how to mitigate it Understand and apply pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Responsible for safety surveillance for pharmaceutical/biological/drug-device combined products Lead and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses and risk management plans Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents Analyze and interpret aggregate safety data and communicate these analyses to cross-functional teams Write, review and provide input on technical documents independently Oversight and responsibility for leading the strategy for periodic reports (PSURs, PADERs, etc.) Oversee safety surveillance and pharmacovigilance activities for products in clinical trials and post-marketing Responsible for implementing risk management strategies for assigned products Proactively engaging, inspiring, coaching and mentoring team and colleagues Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development Coordinate and oversee safety-related activities at a product level across multiple indications or related products for the same indication; assess product safety strategy across the entire program and oversee approval-related activities Qualifications
MD / DO with 2+ years of residency with patient management experience Master of Public Health or PhD is preferred in addition to MD/DO, not required 8-10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry Ability to analyze and guide analysis of clinical data and epidemiological information Ability to present recommendations in group settings both internally and externally Write, review and provide input on technical documents Work collaboratively and lead cross-functional teams Ability to lead cross-functional teams in a collaborative environment Fluency in English (written and spoken) Ability to evaluate and make independent decisions; manage uncertainty and complexity and multitask Experiences / Leadership Traits
Ability to work collaboratively with colleagues from different areas of expertise (e.g., epidemiology, statistics) Ability to make independent decisions Ability to influence cross-functional stakeholders internal and across industry and regulatory authorities Clear understanding of PV and clinical development and monitoring clinical trial and post-marketing safety Respect for other opinions and inclusivity of different viewpoints Additional Information
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of posting based on the job grade for this position. Individual compensation paid within this range will depend on geographic location and may be modified in the future. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs. 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.
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Group Medical Director role at BioSpace (AbbVie). Responsibilities
Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc) Asset strategy lead safety representatives for larger programs (late stage) Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery Work closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA Lead and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA Proactively seek to understand why a safety concern or risk emerges and how to mitigate it Understand and apply pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Responsible for safety surveillance for pharmaceutical/biological/drug-device combined products Lead and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses and risk management plans Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents Analyze and interpret aggregate safety data and communicate these analyses to cross-functional teams Write, review and provide input on technical documents independently Oversight and responsibility for leading the strategy for periodic reports (PSURs, PADERs, etc.) Oversee safety surveillance and pharmacovigilance activities for products in clinical trials and post-marketing Responsible for implementing risk management strategies for assigned products Proactively engaging, inspiring, coaching and mentoring team and colleagues Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development Coordinate and oversee safety-related activities at a product level across multiple indications or related products for the same indication; assess product safety strategy across the entire program and oversee approval-related activities Qualifications
MD / DO with 2+ years of residency with patient management experience Master of Public Health or PhD is preferred in addition to MD/DO, not required 8-10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry Ability to analyze and guide analysis of clinical data and epidemiological information Ability to present recommendations in group settings both internally and externally Write, review and provide input on technical documents Work collaboratively and lead cross-functional teams Ability to lead cross-functional teams in a collaborative environment Fluency in English (written and spoken) Ability to evaluate and make independent decisions; manage uncertainty and complexity and multitask Experiences / Leadership Traits
Ability to work collaboratively with colleagues from different areas of expertise (e.g., epidemiology, statistics) Ability to make independent decisions Ability to influence cross-functional stakeholders internal and across industry and regulatory authorities Clear understanding of PV and clinical development and monitoring clinical trial and post-marketing safety Respect for other opinions and inclusivity of different viewpoints Additional Information
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of posting based on the job grade for this position. Individual compensation paid within this range will depend on geographic location and may be modified in the future. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs. 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.
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