(Associate) Director* Clinical Operational Excellence

  • BioNTech Careers
  • Cambridge, Massachusetts
  • Manager First Level
  • Research, development, teaching
  • Published: 2022-09-23
  • published till: 2022-10-23
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 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.

(Associate) Director* Clinical Operational Excellence

We are seeking for a (Associate) Director* Clinical Operational Execution to join our young and ambitious Global Clinical Operations team, who will support the planning, development, and execution of execution and improvement operational activities related to clinical trials within a multi-functional environment in Clinical Development Organization.
This person will use a risk-based management approach to ensure and disseminate a culture of continuous learning across the organization and serve as a cross-functional ambassador for continuous learning as well as for other Clinical Development Operations (CDO) initiatives.

The (Associate) Director* Clinical Operational Execution will support process development and improvement across the organization, ensuring that BioNTech is bringing the highest quality processes and will be a key driver of identifying process gaps, proposing potential solutions, and implementing these in a harmonized way to help realize BioNTech’s long-term strategy and goals.

Your main responsibilities are:
  • Plan, develop, execute and track process improvement and operational initiatives related to clinical trials and ensure integration with systems, risk-based management approach
  • Evaluate quality measure analysis including performance development and reporting, working towards increased modernization and digitalization, and provide recommendations to the CDO leadership team
  • Maintain a proactive GCP compliance management infrastructure/process, system within GCO, including clinical trial oversight processes, monitoring and quality control of key processes (eTMF), standard operating procedures, process improvement, and training recommendations
  • Ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through the establishment and reporting of clinical performance indicators KPIs/KQIs as well as through the use of innovative and agile methodology to improve processes

What you have to offer.

  • Bachelor’s degree in a business, science or healthcare related field or equivalent. Master’s degree highly preferred
  • At least 8 years of experience in the pharmaceutical / biotech /CRO industry in a relevant field such as Clinical Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance
  • Advanced understanding of the drug development process with solid experience in clinical operations as a must-meet criteria
  • Experience with Six Sigma, LEAN, Agile methodologies
  • Successful and demonstrable track record delivering end-to-end (from conception to benefits realization) process improvement initiatives
  • Demonstrated experience with project management and application of operational excellence concepts
  • Experience working with external parties and/ or leading cross-functional teams

Benefits for you.

  • Benefits for you!
  • Medical, Dental, and Vision Insurance
  • Life, AD&D, STD, and LTD Insurance
  • HRA & FSA Spending Accounts
  • Health & Wellness, including free onsite gym access
  • Adoption & Surrogacy Assistance
  • Vacation and Unlimited Sick Time
  • Holidays and Floating Holidays, including discretionary winter shutdown
  • 401(K) Plan with Significant Company Match
  • Tuition Reimbursement and Professional Development
  • Commuting Assistance and onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more!

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 8121 (please indicate for inquiries) DCA-LI

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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