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Senior Scientific Director/Scientific Director, Pancreatology

Company: AbbVie
Location: Crystal Lake
Posted on: November 11, 2019

Job Description:

Key Responsibilities Includes: ability to lead development of asset/brand strategies. Established track record of leading the development execution of Medical Affairs Plans. Proven ability to contribute to the research platform and data generation cross-GMA: design, evaluate & execute various types of research (clinical research, Phase IIIb-IV, epi, EDA, RWE research). Demonstrated proficiency in designing & overseeing the conduct of Clinical Trials. Proficient at generating protocols, CSRs, disclosure on study details (e.g. clinicaltrials.gov). Serves as key internal subject matter expert for the TA. Broad understanding of the healthcare and bio-pharmaceutical environment. Proven ability to develop and execute an issue management program to anticipate, plan for and respond to issues. Proven ability to successfully lead and influence cross functional teams, including those with senior cross functional members. Demonstrated ability to manage brand medical affairs budget including timelines, compliance requirements. Proven ability to influence or lead teams that generate Scientific Publication strategy. Demonstrated ability to advance Scientific Communication Platforms content. Demonstrated ability to establish Investigator Initiated Study (IIS) strategy. Demonstrated ability to coach TA staff to be docent for IISs. Proven ability to influence and engage key external stakeholders. Demonstrates peer relationship with EEs. Represents Abbvie at external meetings (Ex. Sci or Professional Associations, PhRMA, BIO etc). May serve as unpaid peer reviewer and/or editor for scientific journals. Proficiency & Leadership in Medical Information. Able to influence and actively contribute to regulatory strategy, labeling and agency interactions. Proficient at generating regulatory documents. Stays abreast of key regulatory policies (especially pertinent to human research, scientific exchange and Medical Affairs) as well as regulatory guidance in the therapeutic area. Demonstrated Proficiency & active contribution in drug safety/pharmacovigilance and risk management planning and execution. Extensive understanding of Medical Affairs Compliance Environment ability to educate others. Demonstrated Proficiency & Leadership in Medical Review by providing scientific guidance and issue resolution. May manage and oversee the work of Medical and/or Scientific Directors at all levels. Qualifications: Advanced Degree MD, PhD, PharmD highly preferred. Residency or additional post doctorate experience is highly preferred. Typically 15 years' experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required. Experience in Pancreatology or GI conditions is strongly preferred, but not required Management or leadership experience at the program level, experience with strategy development; senior staff role within a TA. Proven leadership skills in a cross-functional global team environment International experience is a plus. Ability to interact externally and internally to support global business strategy. Ability to run a clinical program or medical affairs team(s) independently with littler supervision. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols. Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. Ability to interact externally and internally to support global business strategy. Most possess excellent oral and written communication skills. Can address problems within discipline or across several projects. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions. Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions. Must relo to Chicago area

Keywords: AbbVie, Crystal Lake , Senior Scientific Director/Scientific Director, Pancreatology, Other , Crystal Lake, Illinois

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