Director Clinical Data Management

Mainz, Germany   |   full time   |   Job ID: 9120 

As a Director of Clinical Data Management, you will be responsible for the effective leadership, strategic planning, and oversight at the portfolio level within the Global Clinical Data Management function. In this role you will ensure the execution and alignment of the data management strategy at the portfolio level to meet evolving business needs. You must have sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and industry standards, and advanced skills partnering with CROs and other third-party vendors. This position requires working cross-functionally with other key stakeholders and leading DM activities to support regulatory submissions and inspections. You must have experience s as a people manager across global teams.

Job Responsibilities

• Supports Senior Director of Clinical Data Management and peer Directors to build out processes necessary to identify, evaluates and executes on functional growth opportunities. 
• Liaises with various internal and external groups (Clinical Development, Clinical Operations, Statistics, Statistical Programming, Pharmacovigilance, and external vendors including CROs) for the implementation of data management activities needed for clinical studies within his portfolio. 
• May represent Data Management in governance bodies externally with CRO partners and stakeholders, and internally in Core teams. 
• Serves as the Data Management Subject Matter Expert representing R&D during regulatory inspections and submissions, and internal audits pertaining to R&D activities within his portfolio. 
• Contributes to departmental SOP and process development and improvement, and integration of technology; support GCP inspection readiness.
• Provides strong leadership within and across Data Management platforms. Facilitates internal information sharing to promote learning and best practices. 
• Identifies major themes and escalates unresolved data or compliance issues to the functional manager(s). 
• Hires, develops, and retains talents. Responsible for the performance management of the Data Management function, including performance of outsourced data management activities. Line manager of CDM staff, accountable for the recruitment, development and succession planning of staff. 
• Provides highest level of CRO/vendor oversight to ensure project plans are executed with high quality. 
• Ensures functional contracts are compliant with financial processes. Acts as a point of escalation. 
• Provides oversight and leads the efforts to implement and develop Data Management processes and tools based on emerging trends, technology, and best practices. 
• Champions Data Management and related expertise to promote best practices across the Drug Development lifecycle.
• Updates skills continually with respect to evolving industry standards, best practices, and therapeutic area knowledge. 
• Provides input to and help develop short-term and long-term strategies to improve vendor oversight practices 
• Provides input on vendor and technology evaluation, selection, and utilization that aligns with scopes of work 
• Oversees and manages the portfolio clinical data management activities and ensures consistency across the different trials within his program; ensures the development and readiness of personnel to deliver on existing programs 
• Maintains continual engagement at the core team and portfolio level to assess needs and build/maintain a capability for data management and analytics 
• Leads systematic professional development and provides strong support for direct reports and other members of the Clinical Data Management portfolio. 
• Supports significant levels of business change, within own organization and across the broader organization, e.g. standardization

Required Qualification, Skills and Experience

• 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.

• A minimum of 12-15 years 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.

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

• Experience with 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 portfolio-level expertise is a plus

• Very good English (written and spoken)

• Proven change management ability 

• Excellent verbal/written communication skills and ability to influence at all levels across functions and build effective relationships.

• High level of cultural sensitivity and proactive communications expertise. 

• Excellent organizational skills 

• Strong leadership skills with a passion for people development and an ability to prioritize and provide clear direction to team members in a highly dynamic environment

• Strong interpersonal skills and proven ability to effectively partner with other crossfunctional departments, includes Clinical Operations and Biometrics to create a bestin-class organization

• Focused and versatile team player who is comfortable under pressure, ambiguity, frequent change, or unpredictability

• Proactive and detail oriented mindset with the ability to ramp up and problem solve across different projects 

• Familiarity with Microsoft Office

• Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, …)

Your Benefits:

It's our priority to support you:

• Your flexibility: flexible hours | vacation account  
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket 
• Your life phases: Employer-funded pension | Childcare 

Apply now - We look forward to your application!

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

Job ID 9120 (please always specify if you have any questions)   

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.