Vp Clinical Development - Munich, Deutschland - ProClinical
Beschreibung
Salary:
Highly Competitive
Job type:
PermanentDiscipline:
VP/Head of Clinical Operations
Location:
Germany- Munich, Deutschland
- Posting date: 29 Feb 2024
Reference:
59200
Proclinical are recruiting for a VP Clinical Development (m/w/d) to join a biotech organisation. This role is on a permanent basis and is located in Munich.
Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.
Responsibilities:
- For this role, you will guide clinical trial planning, setup, launch, and implementation from a medical perspective.
- Offer medical assistance for allocated clinical programs.
- Review data from clinical trials such as safety, efficiency, translational/biomarker, etc.
- Serve as a medical representative in the clinical development and project management team as well as engage with regulatory authorities for allocated programs.
- You will delegate pharmacovigilance actions as a representative of CMO.
- Aid senior management when needed, such as tasks concerning board meetings, regulatory actions, etc.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a doctorate degree in medicine, ideally with a board accreditation in oncology.
- Demonstrable experience in oncology clinical development, such as early and late clinical stage development, development of the clinical strategy, setting up a clinical development plan and target product profiles in collaboration with any other functions.
- A background in the development of clinical study protocols and study reports, which involves expertise on clinical development strategy and study designs.
- A tactical mindset with a background in due diligence actions.
- Expertise on ICH-GCP and any other pertinent guidelines/regulations.
- Acquaintance engaging with regulatory authorities.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Clinical
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