Quality Recruiting. Established Experts.

Medical Director, Medical Affairs

Reference Number: 3093
Location: Mid-West

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

This position 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; safeguarding patient safety. This person 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.

This person 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.

Major tasks and responsibilities will include:

  • Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategies.
  • Participates in design and execution of clinical trial safety, product safety and risk management plans.  May also carry responsibilities for routine and adhoc safety monitoring reports to regulatory agencies. Reviews, assesses and reports applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to the company’s conduct on clinical studies. Oversees the conducts of clinical trials and is medically and scientifically accountable for resolutions 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.
  • Interacts 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.
  • Provides 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.  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.
  • Assists 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.
  • Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
  • Addresses complex problems within discipline/project or across disciplines.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors.
  • Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.

We seek candidates with the following qualifications:

  • MD or equivalent with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
  • 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.
  • 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.
  • 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.
  • Ability to interact externally and internally to support global business strategy.

 

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 3093. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.