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Director* Clinical Operations

Open for hire at one of the following locations –  Shanghai. - Job ID: 7261 

 

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 

 

 

As part of our team of more than 6,000 pioneers, you'll play a central role in solving some of the greatest scientific challenges of our time. In less than a year, we were able to develop our COVID-19 mRNA vaccine to the highest scientific and ethical standards – by far the fastest vaccine development in the history of medicine. We believe our biggest impact is yet to come. BioNTech is investing heavily in its pipeline of cutting-edge treatments for cancer and infectious diseases. The goal is to try to turn many currently incurable cancers into treatable conditions and prevent deaths from diseases that need not be fatal.

 

Our goal is 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. In doing so, we are guided by our three corporate values: innovation, passion and cohesion.

 

If you also want to contribute to giving hope for a healthy future to many people, then we should get to know each other!

 

Director* Clinical Operations (China Country Lead)

 

Your main responsibilities are: 

Lead the BioNTech clinical operations organization in China

  • Setup and grow the China clinical operations team

  • Establish departmental goals, metrics and monitor initiatives and performance

  • Be accountable for execution and delivery of sponsored human subject research across all therapy areas and development phases in China to quality, time, budget, and resources as defined in the study protocol as well as in local regulations, ICH GCP / IND guidelines, and BioNTech written standards

  • Implement a resourcing strategy to ensure availability and competency of resources needed to meet requirements

  • Provide strong leadership, people management, talent retention and individual development to the clinical operations team in China

  • Ensure strategic local input is provided at early stages of clinical development planning to optimize trial feasibility in-country

  • Cultivate strong relationships with important clinical trial sites in China

  • Work in partnership with other functions and closely align to achieve shared company goals 

 

Engage with and provide oversight to our CRO partners in China

  • Ensure the quality and integrity of outsourced clinical trials

  • Actively identify and manage any internal and external risks to the business

  • Build and maintain strong relationships with local vendors including but not limited to CROs, patient advocacy groups and SMOs at strategic and operational levels.

  • Build processes and actively support CROs to achieve best in class site activation timelines for outsourced trials in China.

 

Build efficient collaborations with our strategic development partners in China

  • Provide operational oversight of joint clinical trial programs

  • Serve as a point of escalation in case of challenges in project activities

  • Play an active role in helping to bridge cultural gaps and language barriers

 

 

What you have to offer

  • Natural/ life sciences or medical background

  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects

  • Minimum 12+ years of drug development experience including leadership experience, project management and regulatory submission experience

  • Operational excellence to deliver trials, develop solutions, accelerate trial start-up and recruitment

  • Accustomed to navigate a matrix environment and partner effectively with internal stakeholders, CROs, and sites  

  • Have strong knowledge of the national healthcare landscape as well as health policies and clinical trials landscape in China

  • Operating with a start-up mindset and dealing with ambiguity, ready to take over responsibility at a country level and build a team from scratch

  • Experience in usual software (Word, Excel, Power Point, MS Project)

  • Able to motivate and lead a team/ used to work in a team

  • A continuous improvement mindset and strong creative problem-solving ability - Able to recognize problems and provide solutions

  • Willingness to challenge the status quo / traditional approaches  

  • Excellent organizational and communicative skills

  • Results-oriented mind-set, and ability to manage competing priorities to meet or exceed targets at a country level.


 

Benefits for you

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.


How to apply

Apply now and simply send 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 by using our online form.


Please note:

  • Only applications sent via our online form shall be considered.
  • Only Candidates with the right qualifications and relevant experience shall be shortlisted
  • Incomplete applications shall be rejected
  • BioNTech will run a background check during the hiring process


We are looking forward receiving your application.


*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!


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