Your Key Responsibilities:
Your responsibilities include, but are not limited to:
- Provide input to all phases of DD by focused assessments and based on confidential data
- Identify key opportunities, risks and gaps
- Identify and address key focus topics
- Drive Clinical Line Function assessment documenting reasons for GO / No GO decision to proceed to cDD mandate:
- Support preparation of management decisions
- Conduct Confirmatory Due Diligence (cDD) by leading team of SMEs from relevant GCD line functions according to project needs i.e. including specific clinical expertise for comprehensive and in-depth assessment of available data/source data/safety data to ensure detection of risks, trends and to identify potential issues and risks to patient safety
- Co-ordinate SME team review, discussions and recommendation as well as SME team meetings
- Participate in on-site visit (if required)
- Drive team recommendation based on integrated view on GCD opportunity and prepares final LF approved assessment on behalf of GCD
- Lead the elaboration of comprehensive, accurate and aligned clinical development plans and costs
- Drive evaluation of internal and external budget for potential opportunity covering all GCD line functions
- Presents scientific / technical DD findings to GCD management
- Responsible for GCD DD report
- Support Scientific Deal Review preparation
- Updates GCD LT about the progress of the ongoing DDs
What you ll bring to the role:
Essential Requirements:
- MD or PhD, ideally combined with business management training, at least 5 years solid experience and background in biopharmaceutical clinical development
- Extensive drug development expertise and with experience in clinical development spanning across several therapeutic areas including biosimilar development
- Strong interpersonal and leadership skills, ability to integrate across functions and organizations to build collaborative relationships
- Ability to work in a global team and matrix structure organization
- Well-organized, excellent time management with respect to priorities and self-management
- Excellent communication (written and verbal) coupled with excellent interpersonal skills
- Fluent English (oral and written)
