Lead clinical trial teams to ensure compliance with regulatory standards and drive successful study execution
Develop and review portfolio documents, including Oversight Plans, Process Developments (e.g., Trial RACI), and SOPs
Supervise adherence to regulatory requirements, ICH-GCP guidelines, and conduct relevant training for project team members
Act as the escalation point for challenges in project activities involving sponsor departments or external vendors
Manage and oversee Clinical Trial Managers and Associate Directors Clinical Trial Management Plan resources for the team in alignment with Senior Director, Clinical Operations
Govern CROs and vendors while contributing to strategic sourcing decisions for clinical trials

University degree or experience in a medical profession (e.g., Nurse or Medical Technical Assistant)
12+ years of experience in project management, regulatory submissions, and global study organizations, including 6+ years leading global clinical development teams
At least 4 years of recent Oncology experience within the past 7 years (phase 2 or 3) as a Lead Trial Manager or higher level
Profound knowledge of relevant legislation and international guidelines (ICH-GCP) for clinical research projects
Proficiency in software tools such as Word, Excel, PowerPoint, MS Project
Strong organizational and communication skills with an independent and proactive work approach
Ability to motivate teams, recognize problems, and provide solutions effectively

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Director, Clinical Operations

Key skills