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Associate Director of Clinical Development

Your role:

  • Act as medical-scientific study lead in close collaboration with the clinical program lead and the Asian strategy clinical lead:
  • Develop and/or oversee medical/scientific input to the creation of relevant clinical documents or parts thereof to ensure high quality in close collaboration with the program clinical lead and Asian clinical lead of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
  • Review and sign off all clinical documents in close collaboration with the clinical program lead and Asian clinical lead related to the clinical studies (e.g. Concept sheets, study protocols; CRF development and study reports) within area of responsibility.
  • Manage the clinical team supporting the clinical trial
  • Is responsible for all medical scientific aspects including medical monitoring (oversight of a CRO) of the trial and provide respective guidance to the trial team.
  • Oversee all aspects related to the scientific and medical risks in collaboration with the safety representative
  • Lead the review, analysis and interpretation of study data.
  • Lead the review, analysis and interpretation of relevant regulatory related documents, such as clinical part (including efficacy, safety documents) of CTD, CTA, NDA or briefing book for regulatory meeting.
  • Support communication of study results or relevant to clinical development, such as manuscript, abstract or presentation for scientific and medical congress as assigned.
  • Lead, oversee and support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring.
  • Support biomarker strategy in close collaboration with the global biomarker team. 

 

  • Act as member of the Clinical Team in China:
  • Lead clinical input for assigned study product(s) in order to establish its safety and efficacy and support registration in the shortest possible time worldwide
  • Develop, and prepare study concept sheets, and study protocols in collaboration with clinical and project team members for assigned study in close collaboration with the Asian clinical lead and/or clinical lead.
  • Present the Concept sheet to review board e.g. “Therapeutic Area Review Board” (TARB) and in Integrated Clinical Study Committee (ICSC).
  • Collaborate with clinical trial management members in the selection of principal investigators and recruitment of clinical study sites in close collaboration with the Asian clinical lead and/or the program clinical lead.

 

  • Regional responsibilities for global studies 
  • Provides clinical and scientific input during clinical team meeting lead by the Asian clinical lead and /or clinical lead of the program.
  • Provides for global studies regional input during the concept sheet and protocol development.
  • Support the ongoing global studies in the region by interacting with the reginal study PI, and if needed by interacting with the regional investigators (e.g. for safety or other study related medical topics) in close collaboration with the global study lead.
  • Is responsible in close collaboration with the study lead for regional investigator meetings including planning in close collaboration with the CTL.
  • Gives input for study related translations research questions (e.g. biomarkers) strategy for translational study, if needed
  • support registration in the shortest possible time worldwide

 

  • Strategic Impact
  • Provide reginal clinical input  in submission strategy  and dossiers development, regulatory authority communications
  • Support business development activities: participate in Due Diligence activities and prepare Due Diligence Report in collaboration with Senior Medical Director

 

  • Cooperation:
  • Externally: Liaise with (principal) investigators, consultants, opinion/thought leaders, health authorities, IEC/IRB, Scientific and Patients’ Organizations and academic institutions in area of responsibility
  • Internally: With the global clinical lead and the Asian lead Participate in cross-functional study teams meetings to provide medical/scientific input and in reginal Asian team meetings to provide medical/scientific into e.g. business plan, as assigned, as a clinical team as a reginal representative, main interface with other internal Departments/Functions including Biostatistics, Business Development, Business Unit/Marketing, , Clinical Trial Management & Monitoring, Data Management, Drug Safety, Exploratory Medicine, Research and early development, Legal, Medical Information, Medical Writing, Project Management, Regulatory Affairs, R&D Quality Assurance.

 

Who you are:

Either 2 Associate Medical Directors or one Associate Director and one Clinical Scientist.
Work Experience in Oncology required.
Role level and experience description is for Associate Medical Director.
For Clinical Scientist lower role level and less experience needed.

 

Functional area: Research and Development

Job Requisition ID:  192098
Location:  Beijing - 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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