Senior Director, Immunology Safety & Strategy
AbbVie Inc.
Company 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 . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description Supports the planning and execution of the safety strategy for immunology assets during the entire lifecycle of the drug Leads development and implementation of an asset safety strategy with support of PST-L or management Supports in the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRs, etc. - ensuring medical accuracy, scientific rigor, and clarity of content across immunology assets Facilitates scientific connections and interactions, information exchange across assets within the safety teams Prepares material on competitive intelligence, current disease state, and standard of care for key indications/ disease states Compiles draft slide presentations for internal and external meetings as required Interacts with and influences other cross functional departments (e.g. Clinical Development, Statistics, Regulatory Affairs, Clinical Pharmacology, Medical Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessments to support study participants in immunology studies. Drives process improvement and change management for the Immunology Safety team in conjunction with enterprise-wide and functional area plans. Deep dive in literature search and capable to deliver a strong analysis and summary and proposal for any additional needed safety action Qualifications Scientific or clinical degree (e.g. NP/PA, PharmD, MS, PhD, MPH, including combinations) At least 5+years of pharmaceutical industry experience, preferably in patient safety/ PV Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols Strategic thinking and capacity of analyzing aggregate data and conclude Effectively present recommendations / opinions in group environment both internally and externally Ability to work effectively under circumstances of uncertainty and complexity. Proven ability to critically evaluate and interpret complex safety data from clinical trials, supporting informed risk-benefit decision-making Strong ability to influence individual stakeholders and cross-functional teams in a collaborative environment Must possess excellent oral and written English communication skills. Work collaboratively and lead cross-functional teams Good communication and influence skills Good organization and mastering Microsoft office tools Additional Information 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr AbbVie Inc.
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