Santhera Pharmaceuticals
Liestal / Pratteln / Basel area, Switzerland / Schweizerhalle
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Santhera Pharmaceuticals (Schweiz) AG , Pratteln
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Santhera Pharmaceuticals (Schweiz) AG , Pratteln
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Santhera Pharmaceuticals (Schweiz) AG , Pratteln
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Santhera Pharmaceuticals (Schweiz) AG , Pratteln
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Santhera Pharmaceuticals (Schweiz) AG , Pratteln
1+m.
Senior Clinical Trial & Team Leader
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. For further information, please visit the Company's website www.santhera.com 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 Senior Clinical Trial & Team Leader (100%) Location: HQ Pratteln, Switzerland Scope of Work
The Senior Clinical Trial & Team Leader provides strategic guidance and oversight across clinical trials and leads the Clinical Operations team. Acting as a Clinical Trial Leader, this role plans clinical trials in accordance with company strategy and ensures their compliant and timely execution to final study report within budget. This role leads cross-functional Study Management Teams (SMTs), aligning efforts to common goals. The role reports to the Head of Development and works in close collaboration with multiple functions such as technical development & operations, regulatory affairs, clinical science, biostatistics and drug safety & pharmacovigilance. Key Responsibilities
The Senior Clinical Trial & Team Leader provides strategic guidance and oversight across clinical trials and leads the Clinical Operations team. Acting as a Clinical Trial Leader, this role plans clinical trials in accordance with company strategy and ensures their compliant and timely execution to final study report within budget. This role leads cross-functional Study Management Teams (SMTs), aligning efforts to common goals. The role reports to the Head of Development and works in close collaboration with multiple functions such as technical development & operations, regulatory affairs, clinical science, biostatistics and drug safety & pharmacovigilance. Key Responsibilities
- Provide line management and inspirational leadership to the Clinical Operations team.
- Provide clinical operations related input to clinical development plans and give guidance to implement the best strategy to meet clinical operations demand, in line with the company program.
- Build on, revise and/or adapt as required existing procedures, provide expertise and guidance to the clinical operations team to ensure that industry standard best-practices are met.
- Act as a Clinical Trial Leader executing assigned clinical trials from planning to final study report.
- Development and approval of study documentation, management of study approval process.
- Identification and selection of external service providers ensuring GCP compliant contracts.
- Coordination and oversight of pre-audit and CAPA resolution activities relevant for Clinical Operations.
- University or equivalent education/degree in life science or healthcare.
- 8+ years of experience in clinical development including the management of complex, global, & various stage clinical trials and external service providers; field monitoring experience is desired.
- Line management experience.
- Thorough understanding of the drug development process and advanced knowledge of ICH-GCP guidelines and other relevant international trial regulations.
- Strong financial acumen.
- Strong leadership skills and ability to motivate people.
- Ability to work independently to manage multiple projects in a fast-paced environment with a sense of urgency.
- Fluent in English (additional languages advantageous) and excellent presentation and communication skills to audiences at all levels.
- Pro-active and strong problem-solving attitude with a high attention to details.
- Ability to identify opportunities / major issues and to communicate impact, excellent project management skills.