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Director Medical Due Diligence (m / f / d)
ConfidentialHyderabad / Secunderabad, Telangana25 days ago
Job descriptionMD 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)
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 :
Skills Required
Time Management, biopharmaceutical industry , clinical development, Communication Skills, Due Diligence
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Director • Hyderabad / Secunderabad, Telangana