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Safety Medical Director

Reference Number: 2784
Location: East Coast USA

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Safety Medical Director.

The Safety Medical Director is responsible for managing safety input into global or regional therapeutic or research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of safety data across disease areas and trial programs.  This position takes ownership of the patient safety risk assessment for the assigned product(s), strategically as well as for emerging safety information.  The incumbent will bring deep clinical understanding and judgment to the patient safety risk perspective in benefit risk assessments.  He/she will ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements.  The incumbent will be responsible for overseeing development of the functional strategy or acting as a renowned expert in own field.

Major tasks and responsibilities will include:

  • Designs or manages the implementation of the Physicians and Scientists strategy within Patient Safety TAs both regionally and globally.
  • Uses expertise and knowledge of global issues to develop strategic Physicians and Scientists objectives for inclusion into the company’s annual business objectives.
  • Defines strategies or leads the company’s response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plans.
  • Provides expert advice in the area of specialism, influencing the development of statistics to the global business and Patient Safety TAs.
  • Closely follows medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plans.
  • Liaises with the internal and external medical community to follow developments within areas of expertise.
  • Contributes to ensuring that an adequate number of qualified physicians and scientists is available for Patient Safety to satisfy the company’s objectives in the Patient Safety area.
  • Maintains a high degree of understanding and awareness on new and emerging medical development.
  • Contributes to or manages the development of the senior management team in area of expertise.
  • Follows important developments and trends in scientific literature and develops contacts with opinion leaders.
  • Leads regulatory communication and preparation of higher level documents.
  • Provides TA Disease Area strategic Patient Safety input to drug development and post-marketing programs across life-cycle of substances and products, ensures risk management commitments, risk mitigation and communication.
  • Coaches and mentors junior Patient Safety staff.
  • Chairs peer review discussions in Patient Safety TA.
  • Ensures expert input to all elements of design and interpretation, and optimal use of available tools and methodology (e.g. modelling and simulation).
  • Establishes and represents the “safety view” of the project internally and externally.

We seek candidates with the following qualifications:

  • Degree in medicine and experience as a physician or academic.
  • PhD in scientific discipline preferred.
  • Extensive experience in designing, monitoring and implementing clinical trials and interpreting trial results.
  • Significant experience in advanced research and development.
  • Therapeutic area expertise and commercial understanding.
  • Thorough understanding of pharmaceutical safety, reporting and surveillance processes and 5+ years of experience in Patient Safety as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency.
  • Understanding of the medico-legal aspects of pharmacovigilance.
  • Proven leader of cross-functional delivery teams.
  • Able to influence others within relevant TA.
  • Professional in PS/PV capability including having significantly contributed to safety parts of regulatory submissions and PRMP production.
  • Experience of benefit:risk evaluations.
  • Extensive general medical knowledge.
  • Able to work across TAs and Functions.
  • Research background including peer reviewed publications 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 2784. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.