Medical Director I

  • location: Cambridge, MA
  • type: Contract
  • salary: $119.34 - $140.40 per hour
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job description

Medical Director I

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!

 
location: Cambridge, Massachusetts
job type: Contract
salary: $119.34 - 140.40 per hour
work hours: 9 to 5
education: Doctorate
 
responsibilities:
  • Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
  • Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor.
  • May represent the company's Drug Safety and Risk Management at internal and external meetings. The MD can be appointed as the Global Safety Officer for a specific compound / product.
  • The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle.
  • The individual who assumes this position will interact with multiple levels of management within the company, external stakeholders in the medical community as well with global regulatory authorities.
  • Manage safety surveillance for assigned compounds / products

    • Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals.
    • Conduct analysis of safety data.
    • Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed company products including decisions on seriousness, expectedness, and causality.
  • Provide safety strategic leadership for clinical development programs / program teams

    • Integrate the safety scientific component to build a strategic framework for clinical development plans.
  • Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
  • Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.
  • If applicable, manage Associate Medical Director(s) overseeing their activities for assigned compounds/products.
 
qualifications:
  • Minimum 3 years of experience in drug safety.
  • Knowledge of pre- and post- marketing US and EU regulations
  • Knowledge of clinical pharmacology highly desirable.
  • Demonstrated strategic and critical thinking.
  • Excellent communication skills (oral and written) and excellent organizational skills.
  • The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
  • Demonstrated sense of urgency and accountability for both individual and team-owned work products.
  • Excellent communication skills (oral and written) and excellent organizational skills.
  • Demonstrated ability to work in an entrepreneurial culture
 
skills: Pharmacovigilance, Drug Safety, AD (Adverse Events)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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