Associate Director, Clinical Pharmacology
2 months ago
Company Description
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
Purpose:
Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies. Consistently demonstrates excellent record of accomplishment of Clinical Pharmacology and business objectives. Leads Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.
Responsibilities:
Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).Executes strategy, lead teams and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant section of investigator brochures, white papers, and other similar documents.Leads clinical pharmacology and biopharmaceutics meetings, serve as Clinical Pharmacology representative at Clinical Strategy Team/Asset Development Team and present at various departmental and cross functional teams such as study teams, Clinical Pharmacology leadership team, Journal club.Drives small teams with members from Clinical Pharmacology functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.Authors scientific publications and present at national and international conferences and interact with KOLs/external stakeholders.Conducts due diligence assessments, summarizes results and represents Clinical Pharmacology on business development teams.Represents Clinical Pharmacology at regulatory meetings.Qualifications
*This position is required to sit on-site 3 days / week*PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Masters Degree or equivalent education and typically 12+ years of experience, Bachelors Degree or equivalent education and typically 14+ years of experience;(*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)Excellent interpersonal skillsAbility to interact with functional representatives and KOLs externally and internally and lead team(s)Strategic thinking and enterprise viewProven scientific track record and technical skills to perform the roleKey Leadership Competencies:
Delivers business results while also positioning AbbVie for long-term success
Persistent and resilient finds the way to move good ideas forward
Acts respectfully yet courageously
Connects unrelated concepts, generates original or unique ideas
Influences colleagues to achieve cross-functional alignment
Gives full accountability when delegating and accepts full accountability when delegated to by others
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, andwemay ultimatelypay more or less than the posted range. This range may be modified in 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 to participate in our short-term incentiveprograms. This job is eligible to participate in 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 employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit
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