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Medical Director / Biopharma

This role is a regional Asia strategy lead in close collaboration with clinical lead of the program, not only for Japan. More specifically, the following role are expected.

 

  • Responsible for the regional (Asian) aspects of clinical development plans by giving regional scientific and clinical input to global program teams.
  • Provides regional input to medical/scientific strategies for development products and provides input to reginal aspects for the Target Product Profile (TPP).
  • Develop and/or oversee medical/scientific input to the creation of relevant (reginal or local) clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
  • Reviews all clinical documents related to the clinical studies (e.g. study protocols and study reports) and regulatory relevant document (e.g. clinical study protocolwithin area of responsibility.
  • Oversees all regional medical scientific aspects of the products and provides respective guidance to the Asian strategy team in close collaboration with the clinical lead / global program team members.  
  • Oversees all reginal aspects related to the scientific and medical risk in collaboration with the global clinical team and the safety representative.
  • Propose and drive regional clinical development strategies for assigned product(s) to establish its safety and efficacy and support registration in the shortest possible time worldwide
  • Provide Medical leadership in regulatory meetings and ensures reginal contribution to submission strategy, regulatory dossiers, safety issues in close collaboration the Head of clinical development in Japan or China
Job Requisition ID:  191056
Location:  Tokyo-To - all
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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