临床开发经理

The CS is responsible an******** for the scientific/clinicalimplementation of the Clinical Development Plan at the Clinical TrialTeam level. The CS supports the CPL an******** in the development ofthe Clinical Development Plan an******** clinical trial content (e.g.,protocols, IB********, CRFs, CSRs, regulatory submissions an********) bycontributing to scientific/clinical information aligne******** thestrategy. The CS is the key Clinical Development contact for theClinical Trial Team an******** responsible for:
• Representing Clinical Development as a core team member on theClinical Trial Team
• Providing a clinical review of study-specific documentation an********materials
• Performing clinical data reviews
• Assessing reporte******** deviations
• Ensuring resolution of identifie******** during clinical dataan******** deviation reviews cross-functionally an********Investigational sites in collaboration with the Clinical Trial Team
The CS may present the clinical development aspects of a projectan******** trial results at internal or external meetings (e.g., withRegulatory Author******** meetings with external experts).



• Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledgean******** in the relevant Therapeutic Area preferred
• Minimum 3 years of relevant experience or equivalent combination ofexperience an********.
• Ability to travel up to at least 30% of t******** includinginternational travel