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| Clinical Leader, Biosimilars Task Force |
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The Clinical Leader of the Roche Global Biosimilars Task Force reports reports directly to the Clinical Development Leader, a senior role in the Pharma development organization, member of the Product Development Leadership Team (PDLT). In this role you have additionally a dotted line to the Biosimilar Task Force Leader, Regulatory Affairs, a senior leader of the Pharma group reporting to the Global Head of Regulatory Affairs. You will be a core member of the Pharma Development Regulatory and Technical work stream.
The Pharma Development Regulatory and Technical work stream is a cross-functional globally represented group that reviews regulatory and clinical landscape and develops strategies to offset the impact of biosimilars on the Roche business. The extended work stream reaches out to support all country affiliates partnering in their efforts to track, review and educate local authorities and clinicians. Collectively, these groups are responsible for endorsing and communicating high regulatory standards for the approval of biosimilars.
In this role you
provide clinical advice and input to key stakeholders for the development of the biosimilars regulatory guidelines globally
constantly review clinical biosimilar landscape and new developments to provide clinical direction to the Global Biosimilar Task Force Team and all related work streams in the planning, development and implementation of clinical strategies for Biosimilar-related activities
act as the "Chief Medical Officer" for all Biosimilar related matters, particularly in dialogue with Roche and Genentech Senior Management, and external parties
have responsibility for the coordination of the clinical biosimilar related activities and communication across the organization
interact regularly with life cycle teams - integrating new biosimilar clinical developments within the products life cycle plans
constantly review clinical plans in light of changing regulatory and competitive landscape
Job ID: 00021958 |
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Medical degree
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10 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Basel |
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To be successful in this role you have an MD, with specialization in internal medicine, oncology or rheumatology and a strong Science and Drug Development background.
global experience within Pharma industry
demonstrated experience leading teams during the registration of biopharmaceutical products
demonstrated successful experience interacting with regulatory authorities
proven experience as a successful decisive leader in a strategic multifunctional environment with ability to work across different teams, influencing their decisions
outstanding teamwork and communication skills
ability to work effectively and collaboratively across the organization, cross-functionally and cross-culturally
HR: M. Steininger, Phone: +41 61 68 74894 |
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At Roche, 80,000 people across 150 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, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site. |
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