(Associate) Director* Clinical Operations Training Management
- BioNTech Careers
- Cambridge, Massachusetts
- Research, development, teaching
- Published: 08.08.2022
Become a member of the BioNTech Family!
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.
Director* Clinical Operations Training Management
Your main responsibilities are:
- Develop compliant, comprehensive, and effective training processes and sessions, and continuously monitor training efficiency and effectiveness, proactively identify training gaps, and partner with key stakeholders to scope and ensure alignment with strategic priorities.
- Develop and execute training strategies for new, improved processes that support an agile working model and monitor external environment, regulatory/process, ICH/GCP changes impacting CDO practices and ensure required changes are implemented.
- Drive development and maintenance of CDO training curriculum, including Onboarding, Role-specific Process Training and Professional Development Programs ensuring all training reflects current industry best practices and regulatory standards in line with associated internal processes and systems.
- Work with cross-functional training leads to ensure harmonization of processes across all training programs and work towards increased modernization and digitalization, new technology and tools for internal and external training.
- Support VP, CDO and Sr. Director, Process Excellence in cross-functional efforts to build out infrastructure necessary to identify, evaluate and execute on functional growth opportunities.
What you have to offer.
- Bachelor’s degree in a business, science or healthcare related field or equivalent. Master’s degree preferred.
- Many years of experience within Clinical Operations , Clinical Trial Management, Clinical Trial Monitoring or related function within pharmaceutical/ biotech/ CRO or related field is required. (i.e. CRA, Quality, Audit, Regulatory Compliance or similar)
- Significant experience in curriculum design in a pharmaceutical environment
- Ability to deliver training on critical aspects of Clinical Trial Management such as ICH/GCP Guidelines, Monitoring Oversight, Site Interactions, non-compliance, Risk management, Inspection readiness etc.
- Broad experience in the pharmaceutical industry with a strong clinical development understanding. Expert knowledge of ICH Guidelines, FDA/ MHRA/EMA regulations, EU Clinical Trial Directive and other applicable industry regulations, processes and practices is required.
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
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 6690 (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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