Sr. Director, Nonclinical Safety & Portfolio Strategy

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          "text": "<p><strong>Description:</strong></p><p>AbbVie’s Development Biological Sciences department is seeking a Senior Director for its Portfolio Leadership Group. This pivotal leadership role will serve as a nonclinical safety representative for assigned molecules across AbbVie’s diverse portfolio. As a safety representative, the Senior Director will be responsible for the overall strategy and execution of the nonclinical toxicology program, collaborating cross-functionally with project leads, providing data interpretation at various internal and external venues, and authoring regulatory documents.&#xa0;</p><p>The ideal candidate will have 15+ years of experience in the area of non-clinical safety within the pharmaceutical industry. He/she should have the experience and ability to develop drug candidates from discovery through marketing. This senior-level position is expected to have a high impact contributing scientific expertise in nonclinical safety assessment, knowledge of industry best practices and pertinent regulatory guidelines, and a vision of future enhancements in the field.</p><p><strong>Responsibilities:</strong></p><p>&#xa0;</p><ul><li>Drive the strategic vision and direction for nonclinical safety, influencing key R&amp;D and portfolio decisions at the organizational level.</li></ul><ul><li>Serve as an active member for multi-disciplinary project teams as a nonclinical safety functional area subject matter expert.</li><li>Articulate and communicate non-clinical safety strategies and provide development plans for multiple drug modalities including but not limited to small molecules, biologics, ADCs, and/or cell and gene therapies, across various therapeutic areas including but not limited to oncology, neuroscience, and immunology.</li><li>Participate in due diligence reviews of drug products to identify potential risks and provide recommendations for partnership or in-licensing.</li><li>Author and submit regulatory documents (IBs, INDs/CTAs, NDAs/BLAs, regulatory queries) and interact with regulatory agencies (US and ex-US) as needed.</li><li>Generate impurity, excipient and metabolite risk assessments as necessary during the life cycle of a drug candidate.</li><li>Lead, mentor and develop others as it pertains to drug development and the execution of the portfolio, with an emphasis on the nonclinical aspects.</li><li>Participation in pharmaceutical industry consortia related to nonclinical aspects of drug development.</li></ul>",
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          "text": "<ul><li>PhD or DVM required.</li><li>15+ years of relevant experience in pharmaceutical industry leading nonclinical safety programs.</li><li>Experience authoring relevant regulatory documents and responding to requests from regulatory agencies.</li><li>Deep expertise in a particular therapeutic area or modality (e.g. immunology, gene therapy, etc) is a benefit, but not required.</li><li>General awareness and understanding of drug metabolism and pharmacokinetics and its interplay with safety (e.g. MIST, drug-drug interactions, toxicokinetics, anti-drug antibodies...) is a plus.</li><li>Skilled in project/program management and leadership.</li><li>General computer skills and knowledge of the Microsoft applications including but not limited to Microsoft Word, Excel, and PowerPoint and applying AI as appropriate and necessary.</li></ul>",
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          "text": "<p><strong>About AbbVie</strong></p><p>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&#xa0;<a href=\"http://www.abbvie.com/\" rel=\"noopener noreferrer\">www.abbvie.com</a>. Follow @abbvie on&#xa0;<a href=\"https://www.linkedin.com/company/abbvie/\" rel=\"noopener noreferrer\">LinkedIn,</a>&#xa0;<a href=\"https://www.facebook.com/AbbVieGlobal/\" rel=\"noopener noreferrer\">Facebook</a>,&#xa0;<a href=\"https://www.instagram.com/abbvie/\" rel=\"noopener noreferrer\">Instagram</a>,&#xa0;<a href=\"https://twitter.com/abbvie\" rel=\"noopener noreferrer\">X</a>&#xa0;and&#xa0;<a href=\"https://www.youtube.com/user/AbbVie\" rel=\"noopener noreferrer\">YouTube.</a></p>",
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          "text": "<p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&#xa0;local law:&#xa0;​</p><ul><li><p>The compensation range described below is the range of possible base pay compensation that the Company&#xa0;believes in&#xa0;good faith it will pay for this role at the time&#xa0;of this postingbased on the job grade for this position.&#xa0;Individual&#xa0;compensation paid within this range will depend on many factors including geographic location, and&#xa0;we&#xa0;may&#xa0;ultimately&#xa0;pay&#xa0;more orless than the posted range. This range may be&#xa0;modified&#xa0;in the&#xa0;future.&#xa0;​</p></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&#xa0;medical/dental/vision&#xa0;insurance and 401(k) to eligible&#xa0;employees.​</p></li><li><p>This job is eligible to&#xa0;participate&#xa0;in our short-term incentive&#xa0;programs.&#xa0;​</p></li></ul><p>Note: No amount of pay&#xa0;is considered to be&#xa0;wages or compensation until such amount is earned, vested, and&#xa0;determinable.&#xa0;The amount and availability of any bonus,&#xa0;commission,incentive, benefits, or any other form of&#xa0;compensation and benefits&#xa0;that are allocable to a particular employee&#xa0;remains&#xa0;in the Company's sole and&#xa0;absolute&#xa0;discretion unless and until paidand&#xa0;may be&#xa0;modified&#xa0;at the Company’s sole and absolute discretion, consistent with&#xa0;applicable law.&#xa0;</p><div sr-tagline=\"\"></div><p>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.&#xa0;</p><p>US &amp; Puerto Rico only - to learn more, visit&#xa0;<a href=\"https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html\" rel=\"noopener noreferrer\">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</a></p><p>US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p><a href=\"https://www.abbvie.com/join-us/reasonable-accommodations.html\" rel=\"noopener noreferrer\">https://www.abbvie.com/join-us/reasonable-accommodations.html</a></p>",
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