Clinical Development Specialist

4 days ago

Hyderabad Secunderabad Telangana, India beBeeDueDiligence Full time
Job Description

Your Key Responsibilities include, but are not limited to:

  • Provide input to all phases of Due Diligence by focused assessments and based on confidential data.
  • Identify key opportunities, risks, and gaps in the clinical development process.
  • Drive Clinical Line Function assessment documenting reasons for GO / No GO decision to proceed with Due Diligence mandate.
  • Support preparation of management decisions related to Due Diligence.
  • Conduct Confirmatory Due Diligence (cDD) by leading a team of Subject Matter Experts from relevant GCD line functions according to project needs.
  • 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.
Required Skills and Qualifications

Essential Requirements include:

  • 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 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).

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