Apply now »

Director Clinical Operations

Mainz, Germany; London, United Kingdom   |   full time   |   Job ID: 9757 

 

 

As Director Clinical Operations, you will lead clinical trial teams, ensure compliance with regulatory standards, and oversee vendor management to drive successful study execution. You will play a key role in resource planning, team development, and strategic decision-making to support the delivery of high-quality oncology programs.

 

Your Main Responsibilities Are

 

  • Contribution to the development and review of portfolio documents such as Oversight Plans, Process Developments (including Trial RACI), and SOP development
  • Supervision of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures, and conduct of respective training
  • Point of escalation in case of challenges in project activities with other sponsor departments or external vendors
  • Line Management and supervision of Clinical Trial Managers and Associate Directors Clinical Trial Management
  • Resource planning of the team in alignment with the Senior Director, Clinical Operations
  • Involved in the governance structure and oversight of CROs and vendors
  • Overlooking the process of selection and decision on the participation of vendors for a clinical trial and providing the strategic sourcing approach to the individual study team
  • Contributing to the selection and decision process on the participation of vendors, preferred vendors, and partnership vendors
  • Oversight on project/program timelines and deliverables and identify future program needs
  • Organize and conduct team meetings
  • Taking care of team developments, identification of high-performance team members, and working on team development together with the Senior Director, Clinical Operations
  • Support the QA team during internal audits, vendor audits, and/or hosting inspections
  • Adherence to the regulatory requirements, the ICH-GCP guidelines, and the respective procedures (i.e., policies, SOPs, instructions)

 

What You Have To Offer

 

  • Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
  • Minimum 12+ years of experience in project management, regulatory submissions, and global study organizations
  • Refined colloquial and correspondence skills (written and spoken)
  • Experience in usual software (Word, Excel, PowerPoint, MS Project)
  • Ready to take over responsibility
  • Able to motivate and lead a team/ used to working in a team environment
  • Able to recognize problems and provide solutions
  • Excellent organizational and communicative skills
  • Independent and proactive way of working 

 

 

Your Benefits:

 

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.

 

How to apply:

 

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

 

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

 

We are looking forward receiving your application.

Inspired? Become part of #TeamBioNTech. 

BioNTech, the story 

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.  

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.  

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. 

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!  

BioNTech - As unique as you 

www.biontech.com  

Apply now »