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Location

Cambridge, MA | United States

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Job description

Manager* Biomarker Operations

Your main responsibilities are:

• Execution of the biomarker strategy, including planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples in global Phase I-IV clinical trials
• Ensure biomarker sample related collection, tracking, and storage in compliance with the Clinical Trial Protocol and Patient Informed Consent
• Management of cross-functional integration and execution of operational biomarker elements
• Ensuring biomarker operational deliverables in time and quality (including ICH/GCP regulations)
• Building of efficient biomarker sample logistics from study set-up until data delivery and study close-out
• Establishment and ensuring accurate tracking and reporting of biomarker sample and data metrics
• Work with internal functions on the selection and contracting process for biomarker sample processing and analysis vendors
• Act as liaison point for internal labs to ensure efficient communication and information flow

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 Laboratory Technical Assistant)

• Minimum 3 years of experience in clinical operations or central laboratory operations including clinical sample tracking/management (e.g., biomarker, PK/PD) and/or sample reconciliation activities
• Proven knowledge of analytical methods used in therapeutic areas like Oncology, Immuno-oncology, or Infectious Diseases
• Proven track records of independent contributions to global clinical studies (e.g. in CRO, biotech/pharmaceutical companies and/or central labs)
• Experience in (global) project management and ability to work in a matrix team environment
• Ready to take over responsibility, and able to rapidly enter in action and to work under stress conditions independently and proactively
• First experience in coordinating and guiding team members, and ability to recognize problems and provide solutions
• Refined organizational and written and spoken communication skills in English
• Experience in usual software (Word, Excel, Power Point, MS Project)

Benefits for you

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.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube .  Apply now for your preferred job and location through our careers site .

*BioNTech does not tolerate discrimination, favoritism, or harassment based on 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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Job tags

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Salary