Director* Clinical Operations (Individualized mRNA Cancer Vaccines)

Open for hire at one of the following locations –  Cambridge Erie Street, London, Mainz Goldgrube. - Job ID: 6727 

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

 

Director* Clinical Operations (Individualized mRNA Cancer Vaccines) 

 

The Director* Global Clinical Operations provides leadership and overall strategic management of at least one Platform within clinical development operations. The Director* GCO is a part of the Operations Extended Leadership Team lead by the VP of Operations. This role interacts with and influences senior level management, external vendors, collaboration partners and clinical study personnel for clinical trials and/or entire trial platforms.

 

Your main responsibilities are:

 

• Oversee one to several therapies defined as a “platform” within BNT pipeline
• Ensure consistent, high quality execution across compounds and vendors
• Global study management and vendor oversight required with experience managing direct reports  
• Contribution to development and review of portfolio documents such like 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
• Responsible for the overall success of the clinical study team(s) within a program(s)
• Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
• Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s)
• Key point of contact for clinical platform and study level escalation within the platform
• Provide innovative and flexible operational solutions and options to the teams; assist in preparing scenarios for creative solutions to operational challenges
• Responsible for CTM resource forecasting and resource allocation for clinical studies across one or more clinical programs
• Responsible for line management of CTM and/or CTS staff (e.g. performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, etc.)
• Point of escalation in case of challenges in project activities with other sponsor departments or external vendors
• Resource planning of the team in alignment with the Senior Director GCO
• Involved in the governance structure and oversight with CROs and vendors
• Strategic contribution in the process of selection and decision on participation of vendors, preferred vendors and partnership vendors
• Oversight on overall project/program timelines and deliverables and identification future of program needs
• Organization and conduct of Platform or executive level meetings
• Team developments, performance management, identification of high-performance team members and working on team development together with the Senior Director GCO
• Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)

 

What you have to offer:

 

• Minimum 12 years of experience in pharmaceutical/biotech or related industry with at least 8 years in Global Clinical Development leading cross-functional teams
• Bachelor’s degree in the life sciences or a university degree in a related field with experience in a medical profession. Advanced degree preferred
• Preferred experience with personalized mRNA vaccines in oncology clinical studies
• PMP or equivalent certification desirable
• Profound knowledge and experience working with legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
• Directly involved in addressing regulatory inspections or internal process audits
• Involved in drafting/reviewing responses to Health Authority and Ethics committee questions
• Strong communication and pres