Roche China China
2 months ago
500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.
Designs and provides oversight of clinical research programs. Builds relationships with key opinion leaders and applies their input to enhance study design and protocols. Serves as medical/scientific consultant to marketing or research project teams and government regulatory agencies. Establishes the criterion essential for determining the safety, efficacy, and medical utilities. Interprets results of Phase I-III investigations in preparation for new-drug or medical device application. May serve as safety expert for individual clinical projects. May be responsible for post marketing studies
Your key responsibilities:
Your responsibilities include, but are not... limited to:
•Is a global clinical leader responsible for clinical program(s) across indications or a large regional clinical leader driving medical strategy for development and marketed products in a defined therapeutic area. Owns the risk benefit assessment for the program(s)
•Is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access
•Leads execution on broad strategic direction and contributes to development of disease/therapeutic area strategy
•Leads the creation of clinical components of key documents e.g., Clinical Trial Protocols (CTPs), Investigator’s Brouchures, Clinical Study Reports (CSRs), regulatory documents etc. with high levels of quality and consistency
•Acts as the medical expert, leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders. Collaborates across functions to ensures continuous evaluation of drug safety profile
•Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program. Ensures career development of program reports through active participation in the performance management
•Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
•Distribution of marketing samples (where applicable)
Diversity & Inclusion / EEO
What you’ll bring to the role:
•Accountable for the overall portfolio strategy and deliverables in a given disease area.
•Accountable for the quality and speed of the medical inputs into the programs.
•Accountable for bringing and developing sufficient resource for both project leadership role and medical role in therapeutic area.
•Excellent verbal and written communication skills in English
Clinical Value Lead China jobs
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