Senior Medical Director - Patient Safety

Product Safety Team Lead For Late Stage Oncology ProductsAbbVie'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.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 surveillanceResponsible for safety surveillance for pharmaceutical / biological / drug –device combined productsLead 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 componentApply current regulatory guidance as appropriate for safety surveillance and authorship of PV documentsAnalyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as neededEffectively write, review and provide input on technical documents independentlyOversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)Responsible for implementing risk management strategies for assigned productsProactively engaging, inspiring, coaching and mentoring team and colleaguesOpportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leaderStrong team player, able to adapt and work in a fast pace environmentSignificant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)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 required2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.Previous experience supporting regulatory submissions (IND/BLA submissions) is requiredOncology patient safety experience is requiredEffectively analyze and guide analysis of clinical data and epidemiological informationEffectively present recommendations / opinions in group environment both internally and externallyWrite, review and provide input on technical documentsWork collaboratively and lead cross-functional teamsAbility to lead cross-functional teams in a collaborative environmentThe 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.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.