Director Clinical Operations

Hlx Life Sciences; München; Vor Ort; EUR 75.000 - 105.000; Vollzeit

Zusammenfassung

A leading life sciences company in Munich is seeking a Clinical Operations Lead to manage the Clinical Operations department and oversee clinical studies. The ideal candidate will have a scientific degree, 7+ years of experience in the pharmaceutical industry, and strong regulatory knowledge. Fluency in both German and English is required. This role is 100% onsite and involves strategic planning as well as operational oversight.

Qualifikationen

• 7+ years in the pharmaceutical industry with international experience.
• Proven ability to lead and mentor a department.
• Hands-on mindset, effective in cross-functional teams.

Aufgaben

• Lead and manage Clinical Operations department.
• Support CEO in strategic planning and oversee clinical studies.
• Ensure inspection readiness during regulatory inspections.

Kenntnisse

Clinical research knowledge

Regulatory expertise

Interpersonal skills

Organisational skills

Fluency in German and English

Ausbildung

Degree in a scientific discipline

Jobbeschreibung

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.