Senior Medical Director - Patient Safety

AbbVie · Florham Park, NJ · 2 mo ago

HealthcareFull-time

About the Role

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head, will actively and closely collaborate with the development medical lead to set the strategy for the oncology programs. The PST lead will be responsible for one or more products and will ensure safety through the product lifecycle (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 PK and toxicology leads, regulatory and clinical development leads, and medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first-in-clinical trials as well as PMOS. The PST lead will interpret regulations related to pharmacovigilance supporting all patient safety activities and will lead the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, and 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

Qualifications

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
2-5 years 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

Pay & Benefits

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.

Work Schedule