Senior Medical Director - Patient Safety

Regulatory Toolkit; Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie in Chicago seeks a Product Safety Team Lead for late-stage oncology programs. You will oversee safety surveillance across the product lifecycle, guiding dose selection and safety monitoring in early trials in collaboration with PK, toxicology, regulatory and medical affairs teams.

You will interpret pharmacovigilance regulations, lead PV documentation strategy for NDA/sNDA submissions and risk management plans, and mentor colleagues in a fast-paced environment.

Qualifications

• MD/DO with 2+ years of internal medicine residency and patient management experience.
• Pharmacovigilance/Clinical Development experience in pharma industry.
• Oncology patient safety experience required.
• Experience supporting regulatory submissions (IND/BLA).

Responsibilities

• Conduct safety surveillance by applying pharmacology, chemistry and non-clinical toxicology.
• Lead safety surveillance for pharmaceutical/biological/drug-device products.
• Set strategy for PV documents, including PSURs and NDA/sNDA safety components.
• Apply regulatory guidance for PV document authorship.
• Analyze aggregate safety data and communicate to cross-functional teams and leadership.
• Write and review technical PV documents.
• Oversee periodic reports (DSURs, PSURs, PADERs).
• Implement risk management strategies for assigned products.
• Mentor and lead team; collaborate cross-functionally.
• Co-author publications and participate in safety leadership initiatives.
• Adapt in fast-paced environment.

Skills

Pharmacovigilance

Regulatory submissions

Oncology safety

Cross-functional leadership

Medical affairs collaboration

Education

MD/DO with residency

Clinical Pharmacology fellowship preferred

Job 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.

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS.PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs.

Responsibilities:

• Understanding and application of the 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 but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component


• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents


• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed


• Effectively write, review and provide input on technical documents independently


• Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)


• Responsible for implementing risk management strategies for assigned products


• Proactively engaging, inspiring, coaching and mentoring team and colleagues


• Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader


• Strong team player, able to adapt and work in a fast pace environment


• Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

• MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required


• 2-5years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.


• Previous experience supporting regulatory submissions (IND/BLA submissions) is required


• Oncology patient safety experience is required


• Effectively analyze and guide analysis of clinical data and epidemiological information


• Effectively present recommendations / opinions in group environment 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

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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company's 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