Director, Clinical Data Insight and Strategy

Open for hire at one of the following locations –  Cambridge Hamilton Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 6857 

 

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 Data Insight and Strategy 

 

Responsibilities

•           Lead and provide strategic insights into data management and data related deliverables on portfolio, platform, and study level, specifically focus on data quality, project management for DM milestones and troubleshooting for critical data related topics include but not limited to EDC data, external data and etc. 

•           Responsible for handling rapid analytics/trouble shooting requests from various stakeholders within the organization for data related topics, metrics, and deliverables.

•           Develop analytics strategies, actions and communications plans for internal and vendor team members to help coordinate data management deliverables and requests, as well as mentoring the team for implementation.

•           Supports and work closely with Clinical Data Management LT to ensure DM strategies is executed with consistency and high quality across portfolio, platform, and study level, as well as across CROs.

•           Work closely with DM leaders, proactively identify and support the team to resolve issues related to clinical data throughout the trial lifecycle.

•           May represent Data Management in governance bodies internally and externally with stakeholders and CRO partners.

•           May represent DMLT, Review and assess CRO and external vendors’ contracts, performance, communication, and collaboration for continuously delivery of clinical data to time, cost and quality.

•           Partner within the organization, contributes to the development and delivery of innovative solutions and initiatives, in response to stake holder needs and company requirements. Understands business needs and readily customizes deliverables to address key business needs.

•           As DM leader, explore and introduces data driven approaches to generate business insights to address business planning and needs.  Translate those insights to tangible actions for DM and cross function team.

•           Understands and partner with DMLT, incorporate industry best practice to BNT DM team and support the growth, development of DM to be the driver of cross functional data cleaning process who are focus on timeline, quality delivery and budget. 

•           May support DM department head in launching new processes, business models and other business required areas in the organization.

 

Qualifications

 

Education

•           Natural / life sciences, scientific, or bioinformatics / computer science background (university degree) or former experience in a CRO/ biotechnology/ pharmaceutical company in a Clinical Data Management position

 

Experience

•           A minimum of 12-15 years of experience in a pharmaceutical industry or other clinical research setting with clinical trials; at least 10 years working with clinical data and clinical development processes

•           Solid understanding of US and global regulations and guidelines (e.g., FDA, EMA, ICH) applicable to clinical development; prior success in partnering with regulatory peers to support timely and quality regulatory submissions

•           Highly competent in clinical data management, various EDC systems, CDASH/CDISC standards and medical coding dictionaries.

•           3 years of supervisory experience required; preferred experience with global teams located in several offices

•           Experience with function/departmental resource allocation and labor requirement assessment.

•           Must have relevant technical skills, CRO oversight, QA/QC, and submission preparation experiences within the pharmaceutical/biotechnology industry.

•           Specific cross-study level management expertise is a plus

 

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a va