Director, Global Clinical Operations

Role Summary

Director, Global Clinical Operations provides leadership and overall strategic management of at least one Platform within Clinical Development Operations. This role interacts with and influences senior level management, external vendors, collaboration partners and clinical study personnel for clinical trials and/or entire trial platforms.

Responsibilities

• Platform Lead: Oversee one to several therapies defined as a ‚Äúplatform‚Äù within BNT pipeline. Ensure consistent, high quality execution across compounds and vendors. Global study management and vendor oversight required with experience managing direct reports.
• 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‚Äôs 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
• 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.)
• Point of escalation in case of challenges in project activities with other sponsor departments or external vendors Resource planning of the team in alignment with the Senior Director Global Clinical Operations
• 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 Oversight on overall project/program timelines and deliverables and identification future of program needs
• Organization and conduct of Platform or executive level meetings
• Team developments, performance management, identification of high-performance team members and working on team development together with the Senior Director GCO
• Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)

Qualifications

• 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‚Äôs degree in the life sciences or a university degree in a related field with experience in a medical profession PMP or equivalent certification desirable
• 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 programs (Word, Excel, Power Point, MS Project) as well as knowledgeable of electronic data systems and technical solutions such as eTMF, IWRS, EDC, etc. and developing presentation material
• Strategic thinking - successfully develop strategic direction for clinical programs and sets objectives and priorities in alignment with the program goals. Identifie potential opportunities and manage risks
• Experienced in building high performing teams through talent development and coaching, developing honest relationships, and generating trust by demonstrating consistency between words and actions
• Proactive in assuming responsibilities even when dealing with ambiguity in a rapidly changing environment
• Capable of maintaining a current and strategic view of talent management, aligned with company priorities and needs

Skills

• Strategic thinking and leadership
• Cross-functional collaboration
• Regulatory compliance and ICH-GCP expertise
• Vendor management and governance
• Resource forecasting and budgeting
• Team development and performance management
• Advanced MS Office and clinical systems (eTMF, IWRS, EDC)