Director* Clinical Development Infectious Diseases

Open for hire at one of the following locations –  Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 6802 

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
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 Development Infectious Diseases 

 

 

Your main responsibilities are:

• Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle. For all these tasks, work in close collaboration and alignment with clinical development lead. Ensure all questions / issues requiring medical oversight are brought to the attention of the clinical development lead.
• Work to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Contributes to the Data Review and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). This could also include support for Case Report Form (CRF) development, and implementation of data capture tools.
• Contribute to the development of the clinical protocol. Also contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead.
• Provide insights to and facilitate data review process improvements, for example by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement.
• Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers.  Contribute to the review and writing of clinical trial documents for study CSR activities, and publications (if applicable).
• Support pharmacovigilance activities (e.g. contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings)
• Support regulatory activities, like preparation and conduct of meetings with regulatory agencies.
• Produce training materials, share best practices and provide training to the broader clinical trial teams.
• Support preparation and (if applicable) participate in study level meetings for example Investigator Meetings, Data Monitoring meetings, and others.

 

What you have to offer.

• Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required.
• Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
• 2 years+ scientific, strategic and operational experience in planning, executing, reporting and/ or publishing clinical studies (pharmaceutical industry or academia)
• Good knowledge of procedures in global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution.
• Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3; ideally paired with experience in Infectious Diseases  
• Knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Ideally first experiences in how to improve and accelerate processes, systems and tools and drive continuous improvement.
• Experience in RDC is an advantage.
• Experience to work in a matrix, ability to influence without authority
• High flexibility and adaptive working style, ability to work on several tasks at the same time
• Ability to work effectively under high time pressure, while maintaining high quality standards
• Ability to effectively prioritize ta