Senior Director* Clinical Operations - Portfolio Lead - Focus CAR T Cells

  • Cambridge, Massachusetts
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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.

Senior Director* Clinical Operations - Portfolio Lead - Focus CAR T Cells

As part of our global Clinical Operations department, you will be responsible for leading the planning and strategic set-up of a Clinical Trial Portfolio, including planning of required resources as well as relevant vendors and systems. Thus, you will be leading the Portfolio team and be the point of escalation for the (Associate) Directors Clinical Operations (platform leads) for clinical trial activities. You are accountable for the continuous adaptation of internal departmental processes to the rapidly growing organizations within BioNTech. Your main responsibilities are:
  • Oversee activities related to the heading of the project teams, the supervision/ control of third party providers, the timely performance of all services, as well as stakeholder management of all departments involved
  • Oversee the development and review of portfolio documents such like Oversight Plans, Process Developments (including Trial RACI) and SOP development
  • Point of escalation in case of challenges in platform or vendor-related activities with other departments or external vendors; contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors
  • Taking care of team developments, identification of high-performance team members and working on team development
  • (Assurance of) 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), combined with 15+ years of experience in project management, regulatory submissions and global study organizations
  • Extensive CAR T cell experience
  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
  • Profound experience with the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs
  • Excellent communication and ability to recognize problems and provide solutions
  • Able to rapidly enter in action and to work under stressful conditions
  • Able to motivate and lead a team

Benefits for you.

BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
  • 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 free onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • Plus more benefits that will be shared upon hire!

Have we kindled your pioneering spirit?

Then apply now for our location Cambridge, Massachusetts 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 3715 (please indicate for inquiries)

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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