Executive Director, Clinical Science

Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; New Jersey, US   |   full time   |   Job ID: 9743 

 

 

 

 

SUMMARY/JOB PURPOSE: The Executive Director (ED) of Clinical Science and Clinical Center of Excellence leads a best-in-class Clinical Science and Center of Excellence function at BioNTech to provide scientific and process expertise necessary to design and deliver early and late phase clinical studies. The ED of Clinical Science and Clinical Center of Excellence serves as a member of the Global Development Leadership Team. S/he manages a team of Clinical Scientists who are accountable for best practices in the design and conduct of clinical studies, clinical document excellence, medical data integrity, medical monitoring and clinical trial innovation. The ED of Clinical Science and Clinical Center of Excellences oversees the pipeline (portfolios) of clinical programs and process improvement initiatives impacting the Clinical Development organization and ensures cross-functional teams are formed, objectives set, and timelines achieved. S/he recruits highly qualified leaders and individual contributors to the organization as well as establishes the vision, mission, and culture of the team. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Supports resource forecasting, talent development, succession planning, and retention strategies.
• Builds a collaborative, supportive learning environment.
• Ensures and contributes to a consistent and high level of training for Clinical Scientists across the department with respect to relevant scientific data and knowledge, including SOPs and Working Practices
• May serve as a delegate for Clinical Development Portfolio VPs  as needed
• Partners with Clinical Development VPs to advance the portfolio/pipeline
• Leads teams to ensure high quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings
• Oversees the portfolio/pipeline of clinical studies to ensure consistency of clinical deliverables across program(s)
• Ensures high quality and timely delivery of protocols and data; implements quality assurance plans in collaboration with the QA organization

• Partner with QA and GDO to develop vision for embedding and operationalizing Quality by Design throughout the trial lifecycle
• Develop metrics and collect indicators that enable ability to track output and trends associated with protocol development and can be applied to identify areas of continuous improvement.
• Serve as clinical science/development subject matter expert to support quality and compliance efforts across the therapeutic areas and guide compliance to GCP.  Interface with key stakeholders across other departments to support a culture focused on quality across BioNTech.

• Maintains an advanced understanding of the status of all trial activities
• Champions clinical trial innovation such as novel study designs, dose escalation methods, decentralized trials, EMR to EDC, generative AI, data science and real-world data, and other approaches to accelerate clinical trials and reduce the burden on patients and sites.
• Serves as an internal subject matter expert on the latest best practices, industry standards, and novel approaches in clinical science/development excellence
• Leads resourcing and budget planning activities for the Clinical Science/Development organization, including contractors and Functional Service Providers

• Lead the development and delivery of educational and training programs focused on advancing clinical development capabilities while developing a high functioning community of practitioners

• Lead team focused on developing and maintaining clinical processes across Early and Late Development and serve as senior voice in supporting quality and compliance-related activities
• Holds accountability for the performance and professional development of the Clinical Scientist team
• Serves as a key cross functional collaborator; represents the Clinical Science function and/or the entire clinical Development function in various process improvement initiatives and/or cross functional activities
• Collaborates to support incoming asset and/or business development activities (i.e., due diligence)

 

SUPERVISORY RESPONSIBILITIES:

• Functional head role, manager of managers.