Scientific/Medical Director, Medical Affairs - Gastro Pipeline

Job Description
*Preferred location is Lake County, IL but can sit remotely anywhere in the US.
*Position title will be based on qualifications listed below.
Provides specialist medical and scientific strategic and operational input into core medical affairsactivities 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 (AE’s &
SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
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 (AE’s) and Serious Adverse Events (SAE’s) 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.
May assist in 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.
May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.E., commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.