Job Description
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 www.abbvie.com . Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. Job Description Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access. Responsibilities Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy. Responsible from Global Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AEs & SAEs) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. Screens, selects and drives the execution of investigator initiated studies and is responsible for oversight of study enrollment and overall timelines for key deliverables. Provides in-house clinical expertise for multiple myeloma, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes partnering with clinical and precision medicine colleagues on the design and implementation of translational strategies. Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AEs) and Serious Adverse Events (SAEs) if assigned to AbbVie conduct on clinical studies. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. May lead delivery of scientific alignment plan, brand plan, and integrated tactical plan. Develops innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development of others. May lead the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. Helps to drive the execution of the molecule and disease specific publication plan based on the unmet needs, evolving data and evolving treatment landscape through a crossfunctional collaboration with publication lead and clinical development team.. May interact with and coordinate appropriate scientific and medical activities with internal stakehol