BioNTech SE logo
BioNTech SE

Our vision is to harness the power of the immune system to develop novel therapies against cancer & infectious diseases.

Director, Global Clinical Operations

Clinical OperationsClinical OperationsFull TimeRemoteLeadTeam 1,001-5,000Since 2008H1B No SponsorCompany SiteLinkedIn

Location

New Jersey + 2 moreAll locations: New Jersey, Maryland, Massachusetts

Posted

1 day ago

Salary

$168.1K - $268.7K / year

Seniority

Lead

Bachelor Degree12 yrs expEnglishGoogle Cloud PlatformPMP

Job Description

• 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.

Job Requirements

  • Bachelor's degree in life sciences or related field; PMP certification desirable
  • 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.

Benefits

  • Competitive remuneration packages
  • Annual bonus
  • Equity based on company and individual performance

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