Senior Medical / Science Director Neuroscience
Chicago, IL 60045
Location: Chicago, Illinois
Industry/Department: Pharmaceutical / Biotech - R&D - US Medical Affairs
1. Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as:
a. Health-care professional/provider interactions
b. Generation of clinical and scientific data (enhancing therapeutic benefit and value)
c. Educational initiatives (medical education, data, guidelines and value proposition)
d. Safeguarding patient safety
2. Works 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.
3. Provide scientific and technical support for assigned products
a. Deliver scientific presentations
b. Develops professional and credible relationships with key opinion leaders
c. Actively participate with Brand Teams and helps develop medical affairs strategies
d. Develop innovative research concepts for clinical data generation
e. Provide relevant scientific and technical training.
1. Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
2. Oversees the design, risk management and executions 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.
3. All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or to generate data for label inclusion.
4. 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.
5. Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information.
6. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
7. May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
8. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
1. Medical Doctorate (M.D.) degree or equivalent with Neurology therapeutic specialty 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.
3. Minimum of 2 years (3+ preferred) of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
4. Proven leadership skills in a cross-functional global team environment. Ability to run a clinical study or medical affairs team independently including regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
5. Must possess excellent oral and written English communication skills.
6. At least one further major international language is preferred.
1. Visa Candidates Not Considered
2. Competitive Base Salary
3. Full-time Benefits
4. Relocation Assistance Available
5. 2+ to 5 years of experience
6 Medical Doctorate Degree Required