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US Medical Director HCV

Reference Number: 3094
Location: IL

Our client is a global, research-based biopharmaceutical company.  They have asked us to assist them in their search for a US Medical Director HCV.

Major tasks and responsibilities will include:

  • Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data; educational initiatives; safe guarding patient safety.
  • 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.
  • Provides scientific and technical support for assigned products; delivers scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participates in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develops innovative research concepts for clinical data generation; provides relevant scientific and technical training.
  • In cooperation with affiliate medical departments, Marketing, Regulatory Affairs, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects.
  • Coordinates training, identifies training needs, and clinical development strategic initiatives in the context of medical affairs.
  • May supervise 0-10 employees either directly or in a matrixed environment depending on role and level of responsibility.
  • Establishes and approves scientific and medical initiatives that are in alignment with the overall strategic initiatives of global medical affairs.
  • Participates in design and execution of clinical trial safety, product safety and risk management plans. 
  • Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interprets statistical analyses for clinical significance, Private Investigator selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
  • 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.
  • Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
  • Oversees scientific/medical education of 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.
  • Represents the company at external meetings including investigator meetings, scientific association meetings, Medical/Clinical Advisory Boards etc.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
  • Serves as the scientific team interface for key regulatory discussions.
  • May act as medical/scientific leader for several programs within an area.
  • May represent the medical function to the Asset Teams and other cross-functional team meetings as needed.
  • May develop scientifically and medically accurate marketing materials, medical education programs, advisories, and symposia.
  • May assist in developing/mentoring junior medical affairs staff.
  • Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.

We seek candidates with the following qualifications:

  • MD required with relevant therapeutic specialty in an academic or hospital environment.
  • A minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia.
  • Proven leadership skills in a cross-functional global team environment.
  • Ability to interact externally and internally to support global business strategies.
  • Ability to run a clinical study or medical affairs team independently with little supervision.
  • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
  • Expert knowledge in a relevant therapeutic specialty (HIV).
  • Ability to interact externally and internally to support global business strategy.
  • At least one further major international language is preferred.
  • Completion of residency and/or fellowship is preferred.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3094. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.