Medical Director Rheumatology
North Chicago, IL
Location: North Chicago, Illinois
Industry/Department: Pharmaceutical / Biotech - U.S. Medical Affairs
Provides specialist medical/scientific strategic and operational input into core U.S. Medical Affairs activities for Rheumatology such as:
a)Health-care HCP interactions
b)Generation of clinical and scientific data that enhances therapeutic benefit and value
c)Educational initiatives like medical education, data, guidelines and value proposition
d)Safeguarding patient safety
Position will work closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provide scientific and technical support for assigned products;
a)Deliver scientific presentations
b)Develops and maintains professional and credible relationships with, key opinion leaders
c)Actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products
d)Develop innovative research concepts for clinical data generation
e)Provide relevant scientific and technical training
1.Initiates U.S. Medical Affairs activities and generation and dissemination of data supporting overall product scientific and business strategy for Rheumatology
2.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 conduct on clinical studies
3.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
4.All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams
5.May interact with and coordinates 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
6.Provides scientific/medical education to investigators, clinical monitors, and Global Project Team members related to Rheumatology. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a Rheumatology therapeutic area resource
1.Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent such as MBBS meet requirements) with relevant Rheumatology experience in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
2.National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
3.Minimum of 2+ years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred.
4.Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a clinical study or medical affairs team independently with little supervision.
5.Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.