Senior Director, Global Clinical Operations

Role Summary

The Senior Director Global Clinical Operations is responsible for planning and strategic set-up of the Clinical Operations team, including planning of required resources as well as relevant vendors and systems. The Sr. Dir leads the Clinical Operations team and is the escalation point for the Director/Sr. Director Global Clinical Operations for clinical trial activities and line management tasks. Oversees all aspects of clinical trial execution within a portfolio of therapies defined as a "portfolio" within BioNTech's pipeline (includes multiple platforms). Highly skilled in strategic operational execution, effective communication with senior leadership, as well as vendor and stakeholder management. Locations: New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany.

Responsibilities

• Accountable for the continuous adaptation of clinical operations needs and internal departmental processes for the rapidly growing organizations within BioNTech.
• Represents clinical operations in interaction with international collaborations with pharma partners and other collaboration partners.
• Actively driving Governance Vendor Oversight for the main Clinical Research Organizations (CROs) working for BioNTech, running steering committees and control activities to ensure the required compliance.
• Profound experience with the preparation and processing of national and international business experience in clinical operation and clinical development processes. The job holder needs to be able to understand the needs of BioNTech in order to satisfy current and upcoming clinical operations’ need.
• Actively exchanging and communicating with upper management, related internal departments and external departments and collaboration partners to ensure awareness of the department and the required activities. All clinical operations strategies need to be developed under consideration of the local laws, international guidelines (ICH GCP).
• Excellent communication and problem-solving skills are part of the job. S/he oversees activities related to leading the team, oversight of third-party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.
• Initiation of development and review of portfolio documents such as Oversight Plans, Process Developments (including Trial RACI) and SOP development.
• Supervision of the direct reports for adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training.
• Opportune contact to upper management, Clinical Development and other departments.
• Instruction and supervision (line Management).
• Resource planning in alignment with GCDO and GDO.
• Involved in the governance structure and oversight with CROs and vendors.
• Contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors for strategic sourcing.
• Oversight on overall project/program timelines and deliverables and identification future of program needs.
• Team developments, performance management, identification of high-performance team members and working on team development together with GCDO LT.
• Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).

Qualifications

• Education: A Bachelor’s degree in life sciences or a university degree in a related field with experience in a medical profession. Advanced degree preferred (Masters, PhD, MD, PharmD).
• Global clinical trial experience in all phases (phase I-IV).
• Over 8 years’ experience directly managing people.
• PMP or equivalent certification desirable.
• Expert knowledge and experience working with global international guidelines (ICH-GCP) for the performance of Clinical Development Programs.
• Strong Compliance focus with direct experience involved in addressing regulatory inspections or internal process audits. Involved in drafting/reviewing responses to Health Authority and Ethics committee questions.
• Over 15 years’ experience in pharmaceutical/biotech or related industry with at least 10 years in Global Clinical Development with experience preferred in the lifecycle development of Infectious Diseases in LMICs and Oncology programs.

Skills

• Leadership and people management with line management experience.
• Excellent communication and interpersonal skills; ability to interact with senior leadership and cross-functional teams.
• Stakeholder and vendor management; governance oversight with CROs and vendors.
• Strategic planning, resource planning, and project/timeline oversight.
• Problem-solving and proactive issue resolution; strong analytical abilities.
• In-depth knowledge of ICH-GCP guidelines and global regulatory requirements; audit and inspection readiness.