Medical Director, Early Pipeline, Immunology, GPS

Actox; Chicago (IL); On-site; USD 150,000 - 230,000; Full time

Job summary

AbbVie in Chicago seeks a Product Safety Team Lead to independently manage safety surveillance across one or more early development products, providing medical and strategic leadership to the PV team and guiding safety decisions.

You will integrate pharmacology, toxicology, and clinical data to shape safety strategy, write PV documents, oversee DSURs, and ensure regulatory compliance across trials, with collaboration across cross-functional teams.

Qualifications

• MD / DO with 2+ years of residency with patient management experience.
• Pharmacovigilance experience in the pharmaceutical industry preferred.
• Demonstrated ability to analyze and guide the analysis of preclinical, clinical, and epidemiological data.
• Demonstrated ability to author and critically review technical documents.
• Ability to formulate, clearly present, and defend medical safety assessments and recommendations to cross-functional teams and governance bodies.
• Work collaboratively in a team environment and be self-starting and able to work independently.
• Fluency, both written and oral, in English

Responsibilities

• Serves independently as the Product Safety Team Lead for one or more assigned products in early development, providing medical and strategic leadership to the Product Safety Team and driving evidence-based safety decisions.
• Integrates pharmacology, chemistry, clinical data, and nonclinical toxicology to lead safety surveillance and inform product safety strategy.
• Provides safety oversight for pharmaceutical / biological / drug -device combined investigational products, contributes to the authorship of key pharmacovigilance documents, including but not limited to, development product safety assessments, regulatory responses and risk management plans
• Interprets and applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Leads the analysis and interpretation of safety data and communicates conclusions and recommendations to cross-functional teams and governance bodies.
• Effectively writes, reviews and provides input on technical documents.
• Leads the strategy for Development Safety Update Reports (DSURs)
• Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials
• Leads and implements the risk management strategy for assigned products
• Supports other Product Safety Team Leads and due diligence projects as needed
• Interprets applicable pharmacovigilance regulations to guide patient safety activities and cross-functional safety decision-making.

Skills

Pharmacovigilance

Data analysis

Technical writing

Cross-functional leadership

English fluency

Independent worker

Education

MD/DO

Job description

ICompany Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose:

Describe the primary goals, objectives or functions or outputs of this position.

Serve independently as the Product Safety Team Lead for one or more assigned products in early development, with accountability for leading safety surveillance, signal detection, validation, assessment, and risk management activities.

Responsibilities:

• Serves independently as the Product Safety Team Lead for one or more assigned products in early development, providing medical and strategic leadership to the Product Safety Team and driving evidence-based safety decisions.
• Integrates pharmacology, chemistry, clinical data, and nonclinical toxicology to lead safety surveillance and inform product safety strategy.
• Provides safety oversight for pharmaceutical / biological / drug -device combined investigational products, contributes to the authorship of key pharmacovigilance documents, including but not limited to, development product safety assessments, regulatory responses and risk management plans
• Interprets and applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Leads the analysis and interpretation of safety data and communicates conclusions and recommendations to cross-functional teams and governance bodies.
• Effectively writes, reviews and provides input on technical documents.
• Leads the strategy for Development Safety Update Reports (DSURs)
• Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials
• Leads and implements the risk management strategy for assigned products
• Supports other Product Safety Team Leads and due diligence projects as needed
• Interprets applicable pharmacovigilance regulations to guide patient safety activities and cross-functional safety decision-making.

Qualifications

• MD / DO with 2+ years of residency with patient management experience
• Pharmacovigilance experience in the pharmaceutical industry preferred
• Demonstrated ability to analyze and guide the analysis of preclinical, clinical, and epidemiological data.
• Demonstrated ability to author and critically review technical documents.
• Ability to formulate, clearly present, and defend medical safety assessments and recommendations to cross-functional teams and governance bodies.
• Work collaboratively in a team environment and be self-starting and able to work independently
• Fluency, both written and oral, in English

Key Stakeholders:

Group Head, Executive Medical Director, TA head, PST Lead, Analytics / Data Scientists, Project Management and Data Management, Clinical Development, Preclinical Safety, Precision Medicine, Regulatory Affairs

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 this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable 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

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