Associate Director, Biomarker Operations

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Company Summary

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.
 

Responsibilities

  • 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
  • Management of cross-functional integration and execution of operational biomarker elements
  • Ensuring meeting deliverables in time and quality (including ICH/GCP regulations)
  • Building and maintenance of efficient biomarker sample logistics (incl. set-up, tracking, analysis) until data delivery
  • Establishment and ensuring accurate tracking and reporting of biomarker sample and data metrics
  • Lead the selection process for Biomarker analysis vendors until contracting
  • Support relevant functions for the selection process of the central lab
  • Management of day-to-day operational routine activities delegated to biomarker vendors incl. vendor surveillance, performance management

What you have to offer.

  • Minimum of 8 years’ experience in central laboratory operations, study start up (lab manual, requisition forms), clinical sample (eg, Biomarker, PK/PD) tracking/reconciliation and analysis
  • Proven experience with GCP environment and Lab Management System (eg, LIMS)
  • Knowledge in Therapeutic areas like Oncology, Immuno-oncology or Infectious Diseases
  • 2+ years of experience in management of direct reports
  • Proven track records of independent contributions to global clinical studies and clinical operations in CRO, biotech/pharmaceutical companies and/or central labs

Benefits for you.

  • Medical, Dental and Vision Insurance
  • Life, AD&D, STD and LTD Insurance
  • HSA & 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!

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. #LI-DCA

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 5702 (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!

BioNTech - As unique as you

https://biontech.de