Pharmacist (m/w/d)

BioNTech SE

55131 Mainz am Rhein - Deutschland

Biologe/Biologin Arbeit Vollzeit ab 08.10.2025

Beschreibung

Director Clinical Operations
Mainz, Germany; London, United Kingdom | full time | Job ID:9757

As Director Clinical Operations, you will lead clinical trial teams, ensure compliance with regulatory standards, and oversee vendor management to drive successful study execution. You will play a key role in resource planning, team development, and strategic decision-making to support the delivery of high-quality oncology programs.
Contribution to the development and review of portfolio documents such as 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
Point of escalation in case of challenges in project activities with other sponsor departments or external vendors
Line Management and supervision of Clinical Trial Managers and Associate Directors Clinical Trial Management
Resource planning of the team in alignment with the Senior Director, Clinical Operations
Involved in the governance structure and oversight of CROs and vendors
Overlooking the process of selection and decision on the participation of vendors for a clinical trial and providing the strategic sourcing approach to the individual study team
Contributing to the selection and decision process on the participation of vendors, preferred vendors, and partnership vendors
Oversight on project/program timelines and deliverables and identify future program needs
Organize and conduct team meetings
Taking care of team developments, identification of high-performance team members, and working on team development together with the Senior Director, Clinical Operations
Support the QA team during internal audits, vendor audits, and/or hosting inspections
Adherence to the regulatory requirements, the ICH-GCP guidelines, and the respective procedures (i.e., policies, SOPs, instructions)

Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
Minimum 12+ years of experience in project management, regulatory submissions, and global study organizations
Refined colloquial and correspondence skills (written and spoken)
Experience in usual software (Word, Excel, PowerPoint, MS Project)
Ready to take over responsibility
Able to motivate and lead a team/ used to working in a team environment
Able to recognize problems and provide solutions
Excellent organizational and communicative skills
Independent and proactive way of working
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

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