(Senior) International Medical Director - Temporary

Switzerland, Basel-City, Basel

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• Job facts

The (s)IMD acts as a cross-functional partner and successfully operates in a matrix environment with shared accountability and responsibility. The ability to work across multiple cultures and countries is also required.

Depending on the assigned product(s) / Indication(s), the (s)IMD may also contribute to the Medical Education and Congress Activities, provides input to the Advisory Board plan and takes responsibility for aligning advisory board advice requests with the relevant internal and external stakeholders. The (s)IMD may also provide medical expertise to the Commercial team and review promotional materials.

Summary of Main Responsibilities:

Medical Strategy

• Accountable for the evidence generation strategy planning and execution, incl. (but not limited to) identifying medical and access gaps and needs as part of the overall medical strategy


• Responsible for the joint planning and execution of the Medical Strategy for the assigned product(s) / Indication(s)

Evidence Generation Strategy Planning and Execution

• Drives and leads the strategy of the integrated evidence generation activities, incl. Roche sponsored clinical studies, Investigator Initiated Studies (IIS), RWD


• Accountable for evidence generation activities for the assigned product (s) / Indication(s), including risk benefit assessment and medical monitoring in all medical affairs interventional studies


• Takes the role of Lead Scientific Responsible and acts as a member of the Study Management Team (SMT)  


• Assesses the needs and coordinates compassionate use of the assigned product(s)


• Conducts review and approval of investigator initiated studies (IIS) and supported study proposals (incl. Review of affiliate study synopses and sign off of affiliate studies)


• As appropriate, provides medical expertise and scientific data to support Regulatory, Drug Safety, Health Economics and  Public Policy strategy and documents 

Patient Access

• In collaboration with Global Access (GA) and appropriate Affiliates stakeholders, identifies the evidence generation needs/gaps in order to obtain and maintain patient access and integrates them into the evidence generation strategy


• Provides medical expertise and input into the market access, brand and lifecycle strategies and plans (e.g. Life Cycle Plans, Brand Plans, Launch Plans,  Comparative Benefit Risk Assessments and other relevant documents)


• Represents PDMA and provides medical expertise to the appropriate Global Access teams and other relevant teams

External Collaborations

• Develops, advances and maintains TAE interactions and collaborations, incl. those aimed to set up and conduct evidence generation activities


• Represents Roche in peer-to-peer interactions with external collaboration partners, including in patient-company interactions

Compliance

• Responsible for acting in line with legal, regulatory and company standards and codes of practice


• Completes all required training modules as priority

Professional and Technical Requirements:

• MD with relevant clinical experience (patient care decision-making) at the point of care. Specialization degree and experience in the disease area are a plus. 


• Relevant pharmaceutical industry experience in Medical Affairs function (preferably at Global or Regional level)​


• Experience in Evidence Generation within or outside the pharmaceutical industry, including protocol-writing.


• Experience in Compassionate Use Program/Compassionate Use Request management


• Understanding of business context, access and regulatory environments and trends


• Experienced educator/ presenter.


• Experience of partnership with therapeutic area experts and external organizations is strongly preferred


• Previous experience with launch of drugs/indications is preferred


• Clinical or scientific experience in the field of Onco-Hematology is a plus.


• Fluency in written and spoken English

Functional competencies, including but not limited to, organization, prioritization and planning skills, negotiation skills, communication & presentation skills

• Who we areAt Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
  
  Roche is an equal opportunity employer.


• Job facts
  
  
  
  • Location Switzerland, Basel-City, Basel
  
  
  • Function Medical Affairs
  
  
  • Subfunction Medical Information/Scientific Affairs
  
  
  • Schedule Full time
  
  
  • Job level Individual contributor
  
  
  • Job type Temporary (Fixed Term)
  
  
  • Division Roche Pharmaceuticals
  
  
  • Posted since 2019/02/06
  
  
  • Job-ID 201902-103909
  
  


• Get in touchMr. Artur Prib


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