Associate Director*, Clinical Data Management

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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.

The Associate Director Clinical Data Management provides solid core and comprehensive data management expertise to provide high quality data management deliverables on clinical studies within his/her portfolio/platform program(s). He/She is responsible for leading the Clinical Data Management Teams and overlooking the execution of clinical trials, with regard to operational and administrative aspects. This includes day-to-day people management, resource planning, hiring and allocation of Data Management resources to the respective clinical portfolio/platform program(s). The ADCDM is working closely with the (Senior) Director Clinical Data Management to develop forward strategies and processes.
 

Responsibilities

Tasks for above mentioned job/function:
The Associate Director Clinical Data Management provides solid core and comprehensive data management expertise to provide high quality data management deliverables on clinical studies within his/her portfolio/platform program(s). He/She is responsible for leading the Clinical Data Management Teams and overlooking the execution of clinical trials, with regard to operational and administrative aspects. This includes day-to-day people management, resource planning, hiring and allocation of Data Management resources to the respective clinical portfolio/platform program(s). The ADCDM is working closely with the (Senior) Director Clinical Data Management to develop forward strategies and processes.
  • Organizes and conducts team meetings.
  • Takes care of team development, identification of high-performance team members and working on team development together with the (Senior) Director Clinical Data Management
  • Provides guidance to project teams on the oversight and supervision of CRO/third party vendors and organizes trainings as needed. Acts as a mentor for new incomers or may delegate to appropriate team member this activity. Provides continuous feedback to develop team members.
  • Contributes to the development and review of portfolio documents (includes contracts, guidelines, budgets, metrics, KPIs..)
  • Complies with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
  • Identifies the needs of new technology or tools for Data Management and takes active role during  development and implementation.
  • Supervises clinical data management activities within his/her portfolio/platform program and ensures it is per BioNTech standards and strategy.
  • Escalates unresolved data or compliance issues to the functional manager(s).
  • Provides guidance to Subject Matter Experts with regard to standard process developments
  • Ensures the trials processes are aligned within his/her portfolio/platform program(s) and escalates any deviations or foreseen non-compliance.
  • Provides expert support to the Clinical Development Team, on study design issues for BioNTech development projects and portfolio/platform program(s).
  • Represents his portfolio/platform program(s) team among other department leads and functions, and supports cross-functional interactions and problem solving.
  • Participates in strategic vendor selection processes for Clinical Data Management, and actively participate in vendor relationship management, includes escalation.
  • Provides input on developing, revising, and maintaining core operating procedures and templates.
  • Provides support or assist Quality assurance department in conducting audits involving data management activities.

What you have to offer.

      
  • Minimum 12 years of experience in Clinical Data Management with wide practice in oversight of DM activities as a Lead and DM project management
  • Profound knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects and experience with Clinical Database Systems and processes
  • Experience with Clinical Database Systems and processes
  • Experience in leading teams and resource planning

 

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Cambridge, Massachusetts, 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 5201 (please indicate for inquiries)

We look forward to your application! #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!

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