(Senior) Global Clinical Trials Manager*

  • Cambridge, Massachusetts
  • Work experience
  • Research, development, teaching
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Become a member of the BioNTech Family!

BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

(Senior) Global Clinical Trial Manager*

The Clinical Trial Manager (CTM) is responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. S/he performs activities related with the leading of an operational project team, the supervision/ control of third-party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.

Responsibilities
  • Support in preparation of regular status reports to ADCO/SDCO and Chief Medical Officer (CMO), including presentation of project status in meetings
  • Overlooking the clinical operation trial budget
  • Opportune contact with PM and ADCO in case of divergences from the project plan
  • Oversight on project timelines and deliverables
  • Set-up or oversight of study related documents such like Trial Management Plan, Monitor Manual, etc.
  • Contribution to and review of study core documents, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.
  • Co-ordination of project activities with other internal departments or external vendors from start-up to close out of a clinical trial
  • Instruction and supervision of CTCs, CRAs and CTAs (in the scope of a project)




 

What you have to offer.

  • Bachelor's degree in life science or advance degree preferred
  • Minimum 3 years of experience in project management, regulatory submissions, monitoring of clinical trials or clinical trial coordination with practice in project planning and structuring
  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects

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 free onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more!
... and much more.

Have we kindled your pioneering spirit?

Then apply now and simply send us your application documents using our online form. #LI-DCA

*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!

BioNTech - As unique as you

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