Director – Clinical Development

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🕒 vor 29 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $200.000 - $280.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Direktor

Jetzt Bewerben

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Codera

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

🤝 B2B

Biotechnology • Pharmaceuticals • B2B

Codera ist ein B2B-Unternehmen, das mit Biotechnologie- und Pharmaunternehmen zusammenarbeitet, um umfassende Fachkenntnisse und Infrastruktur für die Arzneimittelentwicklung bereitzustellen. Es unterstützt Kunden im gesamten Lebenszyklus der Arzneimittelentwicklung mit technischen, betrieblichen und infrastrukturellen Dienstleistungen, um therapeutische Programme voranzutreiben.

Beschreibung

• Support the planning and execution of clinical development programs, ensuring alignment with overall program strategy and timelines • Contribute to the evaluation and refinement of development strategies to mitigate risks and advance clinical assets efficiently • Participate in the planning, delivery and cross-functional coordination of clinical trials from early to late phases • Assist in the development, review and refinement of clinical trial protocols, ensuring scientific rigor, ethical conduct and regulatory compliance • Provide medical and clinical input throughout the clinical trial lifecycle, including safety monitoring, data interpretation and risk management • Partner with biometrics and medical writing to ensure clinical and nonclinical studies are designed, analyzed and summarized appropriately in accordance with timelines, good quality practices and applicable regulatory requirements • Collaborate with regulatory affairs and other departments to support regulatory strategies, clinical trial submissions and responses to health authorities • Support data analysis and reporting activities, contributing strategic insights to inform decision-making and regulatory submissions

🎯 Anforderungen

• Bachelor’s Degree required • Advanced degree preferred • Minimum 6 years of clinical development experience within the biotechnology or pharmaceutical industry • Experience with multiple, complex programs or studies • Detailed understanding of end-to-end management of clinical trial conduct, clinical drug development and clinical trials operations • Deep understanding of global regulatory requirements and experience navigating clinical trials to approval • Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas • Possess a willingness and ability to work hands-on in a detail-driven, fast-paced, entrepreneurial environment • Strategic agility with strong critical and logical thinking and ability to analyze problems • Ability to establish and maintain collaborative working relationships with internal and external stakeholders

🏖️ Vorteile

• employer sponsored insurance plans including medical, dental and vision coverage • generous paid time off • retirement plan options • additional wellness and professional development programs