Stellenbeschreibung

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1500 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

For our location in Bern, we are looking for a

Senior Clinical Scientist

The Senior Clinical Scientist (SCS) role within the Clinical Pharmacology and Translational Development (CPAT) department is a multifunctional, clinical project position. The position holder works closely with other CPAT representatives as well as cross-functionally related to the clinical development program and the associated  deliverables for an early clinical development program.

Main Responsibilities and Accountabilities:

• Contributes to the scientific development of the clinical development plan as well asindividual clinical studies in alignment with the approved clinical development plan. This includes authorship/ review of clinical documents (protocols, IBs, CRFs, ICFs, CSRs, etc.) to ensure that the scientific content/ rigor is consistent and of the highest quality across the clinical development program.


• Contributes to the clinical oversight and medical guidance in collaboration with the Clinical Lead and Clinical Operations representatives during the conduct of the study.


• Reviews clinical data and contributes to the development of clinical presentations and integration of analyses into clinical documents.


• Works closely with internal stakeholders (Research, Nonclinical Pharmacology and Toxicology, Global Clinical Operations, Data Management, Statistics, Global ClinicalSafety and Pharmacovigilance, Commercial Development, and Regulatory Affairs) and external investigators, key opinion leaders, vendors and other support functions to achieve CPAT deliverable.


• Provides analysis and data interpretation from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents through assisting with such activities.


• Provide support for planning and monitoring of the timelines, resources and budget for the scientific part of the clinical program (Medical Writing, AdBoards etc).


• Manages the processes required to support external study review committees; e.g data monitoring committees, steering committees.


• Contributes to multidisciplinary task forces to support continuous improvement.

Qualifications & Experience:

Education

• Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with ≥ 5 years’ experience in industry led clinical research.


• Advanced degree (MS, PhD or PharmD) in life science/healthcare required with 1-3 years’ experience in industry led clinical research.

Experience

• Strong knowledge of clinical research procedures, GCP and SOPs and understanding of drug development process.


• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.


• Involvement in cross-functional, multicultural and international clinical trial teams preferable. Experience in medical/regulatory writing preferable.

Competencies

• Excellent communication skills.


• Ability to work successfully in a matrix organization.


• Ability to manage  external relationships.


• Fluent in English, oral and written.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.