副总监,医药科学

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PRIMARY FUNCTION

  • Take lead in Clinical Development Activities related to products, protocols or studies.
  • Serve as a scientific and management representative for the project
  • Actively participate in preparing the clinical part of the files and its registration. Review and interpret clinical data.

 

MAJOR RESPONSIBILITIES AND DUTIES

  • Define the outline and content of the protocol.
  • Establish and maintain liaisons with investigators, including investigators selection.
  • Completes tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
  • Analyze and interpret the results.
  • Supervise the study conduct.
  • Assure that results meet the high standards of quality.
  • Support the clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.
  • Contribute to achieving project goals and effectively influence individuals to accomplish objectives in a matrix team environment.
  • Be a scientific/medical reference for the assigned products, protocols or studies.
  • Serve as a key knowledge source for internal stakeholders including Country Medical.
  • Department staff regarding study data, to be utilized in communication media and in documents for the specific disease area.
  • Participate effectively in meetings, ensure interface with all departments involved in the project. Represent the client through contact with Health authorities, KOL, Universities, and CRO’s.
  • Participate and interface with the publication strategy team.
  • Interpret complex clinical data and experimental results.
  • Provide accurate and appropriate medical/scientific input into components of clinical development plans: draft protocol, population selection methodologies, outcome measures etc. This may require specific independent research and investigation (literature reviews, consultations, interviews…) to accomplish this objective.
  • Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
  • Prepare expert reports, including the IB and clinical study report.
  • Support RA during registration process.
  • Contribute to development of summary documents (Safety, Efficacy, Marketing, Approval…).

 

Qualifications

  • A MD level is mandatory.
  • Proven expertise in clinical research (around 5 years) with international Good Clinical Practice.
  • Guidelines, basic knowledge of human experimentation laws and regulations.
  • Experience in Oncology in an asset, experience in medical cleaning of large data set is also an asset .At least one previous experience in oncology is highly recommended.
  • Basic mastery of statistics applied to clinical research.
  • Potential to develop capability to manage people and budget, starting level of mentoring or small teams under stress.
  • Good ability to interpret complex clinical data and experimental results.
  • Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy.
  • Excellent English (writing and speaking) and excellent mastery of English medical terminology.