Director Clinical Operations

London, United Kingdom; Cambridge, US; Mainz, Germany   |   full time   |   Job ID: 9118 

 

 

As Director Global Clinical Operations you provide leadership and overall strategic management of at least one Platform within Clinical Development Operations. In this role you interact with and influence senior level management, external vendors, collaboration partners and clinical study personnel for clinical trials and/or entire trial platforms.

 

Your Main Responsibilities Are

 

• As a Platform Lead you oversee one to several therapies defined as a “platform” within BNT pipeline. You ensure consistent, high quality execution across compounds and vendors. You are responsible for global study management and vendor oversight 
• Contribution to development and review of portfolio documents such like Oversight Plans, Process Developments (including Trial RACI) and SOP development
• Supervision of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training
• Responsible for the overall success of the clinical study team(s) within a program(s)
• Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
• Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s)
• Key point of contact for clinical platform and study level escalation within the platform
• Oversight on overall project/program timelines and deliverables and identification future of program needs
• Organization and conduct of Platform or executive level meetings
• Provide innovative and flexible operational solutions and options to the teams; assist in preparing scenarios for creative solutions to operational challenges
• Responsible for CTM resource forecasting and resource allocation for clinical studies across one or more clinical programs
• Responsible for line management of CTM and/or CTS staff (e.g. performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, etc.)
• Team developments, performance management, identification of high-performance team members and working on team development together with the Senior Director GCO
• Involved in the governance structure and oversight with CROs and vendors
• Strategic contribution in the process of selection and decision on participation of vendors, preferred vendors and partnership vendors
• Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)
• Point of escalation in case of challenges in project activities with other sponsor departments or external vendors

 

What You Have To Offer

 

• Minimum 12 years of experience in pharmaceutical/biotech or related industry with at least 8 years in Global Clinical Development leading cross-functional teams
• Bachelor’s degree in the life sciences or a university degree in a related field with experience in a medical profession
• Profound knowledge and experience working with legislation and international guidelines (ICH-GCP) for the performance of clinical research projects. Directly involved in addressing regulatory inspections or internal process audits. Involved in drafting/reviewing responses to Health Authority and Ethics committee questions
• Strong communication and presentation skills both written and spoken inclusive of confident, articulate, and professional speaking abilities (and experience)
• Able to communicate strategy and decisions in a manner that fosters collaboration and partnerships across different functions
• Empathic listener and persuasive speaker
• Standard use of Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring
• Advanced skills in Microsoft Office program