MEDICAL/SCIENTIFIC DIRECTOR- DERMATOLOGY
North Chicago, IL 60045
Location: North Chicago, IL
Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as:
1.Health Care Professional/Provider interactions
2.Generation of clinical and scientific data (enhancing therapeutic benefit and value)
3.Educational initiatives (medical education, data, guidelines and value proposition)
4.Safeguarding patient safety
Works closely with sales, marketing and commercial teams to:
1.Provide strategic medical input into core brand strategies
2.Support medical/marketing activities and market access
3.Provide scientific and technical support for assigned products
4.Deliver scientific presentations
5.Develops and maintains professional and credible relationships with key opinion leaders
6.Actively participate in relevant Brand Teams
7.Helps develop medical affairs strategies for assigned products
8.Develop innovative research concepts for clinical data generation
9.Provide relevant scientific and technical training.
Key Responsibilities Include:
1.Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
2.Participation in design and execution of clinical trial safety, product safety and risk management plans.
3.May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies.
4.May review, assess and report applicable Adverse Events (AE's) and Serious Adverse Events (SAE's) if assigned to conduct on clinical studies.
5.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.
6.Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
7.Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
8.May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
9.Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.
1.Medical Doctorate (M.D.), PhD/PharmD degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements).
2.Completion of residency and/or fellowship or Immunology degree 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.
5.Ability to run a clinical study or medical affairs team independently with little supervision.
6.Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
7.Expert knowledge in a relevant therapeutic specialty.
8.Must possess excellent oral and written English communication skills.
9.Ex-Us: At least one further major international language is preferred.
1.Base Salary - competitive depending upon experience
2.Full-time Benefits - Industry Leader
3.Interview Travel Reimbursed
4.Relocation Assistance Available - Possible for ideal candidate
6.Visa Candidates Not Considered
7.2+ to 5 years
8.Minimum Education - Doctorate Degree