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Lead Medical Director, Product Development, Neuromuscular, Welwyn
Client:
Location:
Job Category:
- EU work permit required:
Yes Job Reference:
02bfc694f712 Job Views:
92 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
The Position Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Lead Medical Director leads or makes major contributions to development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s)/indication(s). Lead Medical Directors are expected to perform their responsibilities with more independence by comparison to Medical Directors. Minimum Requirements: Board Certified Neurologist with Neuromuscular clinical experience required. Relevant clinical, scientific, or clinical trial/development experience in same/similar therapeutic area required. Significant experience working with the principles and techniques of data analysis, interpretation, and clinical relevance. Experience publishing results of a scientific study in a peer-reviewed journal is preferred. Significant pharma/biotech industry experience OR is a recognized expert in the field. Significant experience designing and conducting clinical trials. Experience authoring a global development plan is preferred. Understanding of Phase II – III drug development. Knowledge and understanding of Phase I & IV drug development is a plus. Understanding of product and safety profiles. Knowledge of medical aspects of GCP, ICH, FDA, EMA, and other relevant guidelines and regulations is required. Four (4) or more years pharma/biotech industry experience OR is a recognized local expert in the field. Up to 30% global travel. Key Skills and Behaviors: Impeccable ethics and alignment with Roche Values. Outstanding attention to detail. Strong interpersonal and verbal communication skills. Effective business presentation skills. Strong negotiation and decision-making skills. Proven abilities for effective planning and oversight of project budgets. Aptitude or proven ability to mentor colleagues. SPECIFIC DUTIES AND RESPONSIBILITIES: CDP Strategy and Planning: Leads or makes major contributions to development of the CD plan for assigned molecule(s)/indication(s). Gathers and analyzes data and information necessary to create the CD plan. Responsible to ensure strategic and operational alignment of the CD plan. Works with other CST members and relevant sub-teams to develop CD plan components. Stays abreast of internal and external developments relevant to CD. Maintains the highest standards and levels of scientific and clinical knowledge. CDP Execution: Leads design, development, and execution of clinical studies. Responsible for development and delivery of key presentations. Acts as CD lead in development of study analytics and data management plans. Cross-Functional Team Leadership: Participates in and/or leads the relevant Clinical Science Team (CST). Represents CD in sub-teams relevant to assigned molecule(s)/indication(s). Regulatory Activities: Takes an active role in development of briefing packages. Participates in health authority interactions. Local/Global Communities: Visible in the local site community, proactively contributes to and promotes scientific discussion in the community. Location: Boston, MA (USA), Basel (Switzerland) or Welwyn (UK). Relocation benefits are provided for this position.
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Client:
Location:
Job Category:
- EU work permit required:
Yes Job Reference:
02bfc694f712 Job Views:
92 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
The Position Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Lead Medical Director leads or makes major contributions to development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s)/indication(s). Lead Medical Directors are expected to perform their responsibilities with more independence by comparison to Medical Directors. Minimum Requirements: Board Certified Neurologist with Neuromuscular clinical experience required. Relevant clinical, scientific, or clinical trial/development experience in same/similar therapeutic area required. Significant experience working with the principles and techniques of data analysis, interpretation, and clinical relevance. Experience publishing results of a scientific study in a peer-reviewed journal is preferred. Significant pharma/biotech industry experience OR is a recognized expert in the field. Significant experience designing and conducting clinical trials. Experience authoring a global development plan is preferred. Understanding of Phase II – III drug development. Knowledge and understanding of Phase I & IV drug development is a plus. Understanding of product and safety profiles. Knowledge of medical aspects of GCP, ICH, FDA, EMA, and other relevant guidelines and regulations is required. Four (4) or more years pharma/biotech industry experience OR is a recognized local expert in the field. Up to 30% global travel. Key Skills and Behaviors: Impeccable ethics and alignment with Roche Values. Outstanding attention to detail. Strong interpersonal and verbal communication skills. Effective business presentation skills. Strong negotiation and decision-making skills. Proven abilities for effective planning and oversight of project budgets. Aptitude or proven ability to mentor colleagues. SPECIFIC DUTIES AND RESPONSIBILITIES: CDP Strategy and Planning: Leads or makes major contributions to development of the CD plan for assigned molecule(s)/indication(s). Gathers and analyzes data and information necessary to create the CD plan. Responsible to ensure strategic and operational alignment of the CD plan. Works with other CST members and relevant sub-teams to develop CD plan components. Stays abreast of internal and external developments relevant to CD. Maintains the highest standards and levels of scientific and clinical knowledge. CDP Execution: Leads design, development, and execution of clinical studies. Responsible for development and delivery of key presentations. Acts as CD lead in development of study analytics and data management plans. Cross-Functional Team Leadership: Participates in and/or leads the relevant Clinical Science Team (CST). Represents CD in sub-teams relevant to assigned molecule(s)/indication(s). Regulatory Activities: Takes an active role in development of briefing packages. Participates in health authority interactions. Local/Global Communities: Visible in the local site community, proactively contributes to and promotes scientific discussion in the community. Location: Boston, MA (USA), Basel (Switzerland) or Welwyn (UK). Relocation benefits are provided for this position.
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