[Remote] Director, Global Clinical Operations (US Remote)
Note: The job is a remote job and is open to candidates in USA. BioNTech SE is a biotechnology company focused on transforming patient lives through innovative therapies. As the Director of Global Clinical Operations, you will lead clinical development operations and ensure high-quality execution of clinical trials while collaborating with various stakeholders to enhance operational excellence.
Responsibilities
• Lead one or multiple therapeutic platforms within BioNTech's pipeline, ensuring consistent execution across compounds and vendors
• Drive cross-functional collaboration with internal departments, external vendors, and global partners to align strategies and achieve operational goals
• Develop portfolio documents such as oversight plans, process developments (including Trial RACI), and SOPs to streamline operations
• Supervise adherence to regulatory requirements, ICH-GCP guidelines, and internal procedures while ensuring proper training for team members
• Provide operational insights into feasibility studies, timeline planning, and cost estimations during clinical program development
• Act as a key escalation point for platform-level challenges while delivering innovative solutions for operational hurdles
• Manage resource forecasting and allocation for clinical studies across programs while overseeing CTM/CTS staff recruitment, mentoring, training, and compliance
Skills
• Bachelor's degree in life sciences or related field
• Minimum 12 years of experience in pharmaceutical/biotech industry with 8+ years leading global clinical development teams
• Proven ability to foster cross-functional collaboration with internal teams and external partners to achieve shared goals
• Profound knowledge of ICH-GCP guidelines and legislation for clinical research projects; experience addressing regulatory inspections or audits
• Strong communication skills with confident presentation abilities; fluent in English
• Advanced project management skills including risk management, performance monitoring, teamwork, and problem-solving
• Strategic thinker with a proactive approach to managing ambiguity in dynamic environments
• Experienced in building high-performing teams through talent development, coaching, and fostering trust
• PMP certification desirable
Benefits
• Competitive remuneration packages
• Benefits in support of our diverse employee base
Company Overview
• At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized. It was founded in 2008, and is headquartered in Mainz, Rheinland-Pfalz, DEU, with a workforce of 1001-5000 employees. Its website is https://biontech.de/.
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Responsibilities
• Lead one or multiple therapeutic platforms within BioNTech's pipeline, ensuring consistent execution across compounds and vendors
• Drive cross-functional collaboration with internal departments, external vendors, and global partners to align strategies and achieve operational goals
• Develop portfolio documents such as oversight plans, process developments (including Trial RACI), and SOPs to streamline operations
• Supervise adherence to regulatory requirements, ICH-GCP guidelines, and internal procedures while ensuring proper training for team members
• Provide operational insights into feasibility studies, timeline planning, and cost estimations during clinical program development
• Act as a key escalation point for platform-level challenges while delivering innovative solutions for operational hurdles
• Manage resource forecasting and allocation for clinical studies across programs while overseeing CTM/CTS staff recruitment, mentoring, training, and compliance
Skills
• Bachelor's degree in life sciences or related field
• Minimum 12 years of experience in pharmaceutical/biotech industry with 8+ years leading global clinical development teams
• Proven ability to foster cross-functional collaboration with internal teams and external partners to achieve shared goals
• Profound knowledge of ICH-GCP guidelines and legislation for clinical research projects; experience addressing regulatory inspections or audits
• Strong communication skills with confident presentation abilities; fluent in English
• Advanced project management skills including risk management, performance monitoring, teamwork, and problem-solving
• Strategic thinker with a proactive approach to managing ambiguity in dynamic environments
• Experienced in building high-performing teams through talent development, coaching, and fostering trust
• PMP certification desirable
Benefits
• Competitive remuneration packages
• Benefits in support of our diverse employee base
Company Overview
• At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized. It was founded in 2008, and is headquartered in Mainz, Rheinland-Pfalz, DEU, with a workforce of 1001-5000 employees. Its website is https://biontech.de/.
Apply tot his job
Apply To this Job