International Medical Director/International Scientific Director
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The International Medical Director (IMD)/International Scientific Director (ISD), reporting to the Group International Medical Director (GIMD) for the HER2+ Breast Cancer Franchise is a key role in the development of medical strategy and execution of the Medical and Evidence Generation Strategy for a product /group of products in HER2+ BC Franchise. The role requires strong disease specific expertise and business understanding to identify and address the relevant medical needs of clinical practice, to successfully support the cross-functional team, preferably with HER2 Franchise experience.
Summary of Main Responsibilities:
- 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)
- 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)
- 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
We are looking for a MD or PhD with relevant clinical experience (patient care decision-making) at the point of care. Specialization degree and experience in the disease area are a plus. With relevant pharmaceutical industry experience in Medical Affairs function (preferably at Global or Regional level and in HER2+ Franchise). You will bring:
- 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 HER2+ Breast Cancer 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.
Roche is an equal opportunity employer.