Clinical Operations Lead (m/f/d)
Location:
office outside of Munich 100% Onsite
Your Role
* Lead and manage the Clinical Operations department, both scientifically and administratively.
* Support the CEO in implementing strategic plans at the site, with potential expansion internationally.
* Plan, coordinate, and oversee clinical studies and projects.
* Analyse and evaluate clinical data from multiple studies.
* Manage trial and site administration, including tracking key documents and producing reports (e.g., safety reports).
* Oversee clinical and non-clinical supply management in collaboration with internal and external partners.
* Review protocols, SOPs, study plans, and other trial documentation.
* Help with sections of clinical study reports, submission documents, and other regulatory documents.
* Help with design and draft protocols, check regulatory requirements, and identify external collaborators (including freelance support).
* Closely monitor ongoing trials in collaboration with Clinical Trial Managers (CTMs).
* Ensure inspection readiness and provide oversight during regulatory inspections.
Requirements
* Degree in a scientific discipline.
* In-depth knowledge of clinical research, regulations, and at least 7 years' experience in the pharmaceutical industry, ideally including international experience (preferably USA).
* Strong regulatory and operational experience across EU and US.
* Proven ability to lead, mentor, and develop a department, fostering a strong quality culture within the organisation.
* Strong network to source and staff new trials.
* Hands-on mindset: a "creator and maker" who enjoys building and contributing directly, not only overseeing.
* Excellent interpersonal and communication skills, with the ability to work effectively in global cross-functional teams.
* Strong organisational skills, ability to prioritise tasks, manage resources effectively, and work independently with high commitment.
* 100% onsite availability.
* Fluency in both German and English.