Overview
Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need.
Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:
Role
Clinical Scientist
Scope of Work
The Clinical Scientist is a key member of a Clinical Science team, who contributes to the design, execution, and interpretation of clinical studies across different phases of clinical development. In close collaboration with cross-functional colleagues, this role ensures the scientific integrity of study protocols, accuracy and integrity of data collection and analysis, supports regulatory submissions, and contributes to the advancement of our clinical development strategy.
Key Responsibilities
* Contribute to the design, writing, and review of clinical study documents, such as study protocols, statistical analysis plans and clinical study reports (CSRs), as well as some other documents (e.g., investigator brochure).
* Provide scientific input into feasibility and operational planning of studies, including clinical trials and real-world evidence-based studies.
* As a member of the Study Management Team, work cross-functionally with Clinical Research Physician, Clinical Operations, Data Management, Biostatistics and other functions as needed to ensure high-quality clinical trial conduct and data integrity.
* Monitor study progress, perform regular medical data review, and support preparations for data snapshots and data analysis to ensure consistency with protocol requirements and scientific objectives.
* Contribute to safety monitoring, including review of adverse events and support of Data Monitoring Committees as necessary.
* Collaborate with study investigators and CROs to ensure the scientific robustness of data.
* Assist in the preparation of regulatory documents and submissions to health authorities as needed.
* Stay current with scientific, medical, and competitive developments relevant to the therapeutic area.
Required Qualifications & Experience
* Advanced degree (PhD, PharmD, MD, or equivalent in life sciences or medical field).
* Experience of at least 5 years in clinical research within the pharmaceutical or biotechnology industry or CRO in rare diseases (preferably neuromuscular).
* Experience in working with multiple vendors and outsourced clinical trials.
* Practical experience with protocol amendments, database locks, CSRs and inspection readiness.
* Preferred: experience with safety studies and interactions with regulatory agencies.
* Strong knowledge of clinical trial methodology, Good Clinical Practice (GCP), and regulatory requirements.
* Solid understanding of drug development process from preclinical through clinical stages.
* Ability to analyze, interpret and present clinical and scientific data.
Required Competencies & Skills
* Ability to perform tasks independently and collaborate with the cross-functional team
* Strong written and verbal communication skills; ability to write clinical documents with scientific accuracy.
* Highly organized, detail-oriented, and able to manage multiple priorities
For this position, the relevant working/residency permit or Swiss/EU-Citizenship is required.
If you are interested in a fast-paced, multicultural, challenging, and innovative working environment and your profile matches our requirements, we are looking forward to receiving your online application in English via LinkedIn or Email, at career@santhera.com
Note for agencies: Recruitment agencies are kindly invited to refrain from sending unsolicited CVs to Santhera.
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