BioNTech is looking for a Senior Director, Global Clinical Operations to lead the strategic planning and execution of our clinical trial portfolio. You will be responsible for establishing the Clinical Operations team, managing resources, vendors, and systems, and ensuring the successful execution of clinical studies worldwide. This role is pivotal in scaling our operations to meet the needs of our rapidly growing organization.
What You'll Do
- Lead the Clinical Operations team and serve as the primary escalation point for trial activities and line management.
- Continuously adapt clinical operations processes to support the organization's rapid growth.
- Represent clinical operations in international collaborations with pharmaceutical and other partners.
- Drive Governance Vendor Oversight for key Clinical Research Organizations (CROs), including steering committees and compliance control activities.
- Communicate proactively with upper management, internal departments, and external partners to align on departmental activities.
- Oversee team leadership, third-party provider performance, and manage problems by collaborating with all involved departments.
- Initiate and review portfolio documents, including Oversight Plans, Process Developments (like Trial RACI), and SOPs.
- Supervise direct reports to ensure adherence to regulatory requirements, ICH-GCP guidelines, and company procedures.
- Conduct resource planning in alignment with GCDO and GDO functions.
- Participate in governance structures and oversight with CROs and vendors.
- Contribute to the selection and decision-making process for strategic vendor and partnership sourcing.
- Oversee overall project and program timelines, deliverables, and identify future program needs.
- Manage team development, performance, and identify high-performing team members in collaboration with GCDO Leadership Team.
- Ensure adherence to all regulatory requirements, ICH-GCP guidelines, and company procedures.
What We're Looking For
- A Bachelor’s degree in life sciences or a related medical field.
- Over 15 years’ experience in pharmaceutical/biotech or a related industry, with at least 10 years in Global Clinical Development.
- 10 years of global clinical trial experience across all phases (I-IV).
- Over 8 years’ experience directly managing people.
- Expert knowledge of global international guidelines (ICH-GCP) for Clinical Development Programs.
- Strong compliance focus with direct experience addressing regulatory inspections or internal audits, including drafting and reviewing responses to Health Authority and Ethics Committee questions.
Nice to Have
- An advanced degree such as a Masters, PhD, MD, or PharmD.
- Experience in the lifecycle development of Infectious Diseases in LMICs and Oncology programs.
- PMP or equivalent project management certification.
Team & Environment
You will lead the Clinical Operations team and serve as the primary escalation point for the Director/Senior Director Global Clinical Operations.
Benefits & Compensation
- Salary range: $198,900 to $318,300 per year.
- Equity compensation that is variable and dependent on company and individual performance.
- BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.
Work Mode
This is a global role with opportunities in the following locations: New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; and Mainz, Germany.
BioNTech is committed to advancing medicine through innovation while fostering a dynamic workplace that embraces diversity.
