VP Clinical Development
VP Clinical Development
Posted on :
05-04-2025
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1 Vacancy
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Job Description
Job Description
Job Title: VP Clinical Development Oncology
Tasks & responsibilities
- In this role you represent Medicine at the International Multidisciplinary Evidence Teams and you take clinical development responsibility for the projects assigned. For example: definition of Target Product Profiles Asset Evidence Plan Pediatric Investigational Plan core Clinical Trial Protocols input to Project Analysis and Data Management Plan Investigator Brochure medical input to the Company Core Data sheet Annual Safety Report / IND Safety Reports preparation for the Milestones Start of Development Proof of Clinical Principle Release of Full Development Release of Submission.
- You provide medical oversight to the clinical trial program within your respective project during protocol development conduct analysis and reporting and you have responsibility for continuous benefitrisk assessment.
- You also oversee medical project budgets for the respective project(s). Thanks to your expertise and profound knowledge you support contacts to external experts advisory boards adjudication committees and Safety Data Monitoring boards.
- In addition you provide medical leadership in regulatory meetings and contribute to submission strategy regulatory dossiers and safety issues.
- You proactively identify the need of studies which need to be conducted and you provide input to Medical Affairs strategy documents such as Scientific Platform Publication Plan Product Maintenance and Optimization Summary.
- Furthermore you review and approve publications within your project in collaboration associate Head of Medicine.
As a VP Clinical Development you:
- You author Investigators Brochures Asset Evidence Plans Core Clinical Trial Protocols and Pediatric Development Plans together with your crossfunctional project teams.
- Mentor team of Clinical Program Leads
- You also provide input to Project Analysis & Data Management Plans Company Core Data Sheet Annual Safety Report / IND (Investigational New Drug) Safety Reports.
- Thanks to your expertise you provide medical leadership in regulatory meetings and support submission strategy regulatory dossiers and safety issues.
- With your profound knowledge you maintain an external focus to ensure a good understanding of the relevant customer groups for your designated asset(s) e.g. Health Authorities Key External Experts Associations Patient groups Payers among others. You oversee and support all contacts to external experts executive/steering committees adjudication committees and Safety Data Monitoring boards for your projects.
Requirements
- MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry
- Successful track record in planning conduct and publication of Basic Science and/or Clinical Research
- Sound medical and scientific leadership to drive highpriority projects in collaboration with global matrix teams regional counterparts and external partners
- Previous contacts with regulatory authorities international societies and other relevant international stakeholders
- Good communication and presentation skills
- Excellent crossfunctional collaboration skills and ability to work in virtual teams
- Full command of English language
The VP Clinical Development role additionally requires:
- MD (specialist in Oncology or equivalent) with sound clinical oncology experience and multiple years of experience in the pharmaceutical industry
- Profound clinical development experience as well as multiple years of experience in Pharmaceutical Industry in an international role. Former responsibility for international clinical development projects is also required
#LIOG1
Required Experience:
Exec
Employment Type
Full-Time
Key Skills
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