Job Title: Senior Director, Clinical Program Operations - Europe (Germany, France, UK)

Location: Primarily remote-based, with head office based in North Germany and operations in France and the UK. You will be required to occasionally travel across the EU and to regularly commit time, when necessary, to commute into their German offices.

Industry: Biotechnology - Oncology
Employment Type: Full-Time
Reports To: SVP Clinical Development & Program Strategy
Salary: €140,000 + Excellent Benefits + Travel & Expenses

About the Company:

iO associates are delighted to be supporting a cutting-edge biotech oncology company with a mission to transform cancer care through the development of novel, targeted immunotherapies.

Their pipeline continues to steadily advance through pivotal clinical stages, and they're now seeking a bold, mission-driven leader who thrives at the intersection of science, operations, and global execution.

Role Overview:

I'm looking to speak to Senior Directors, Directors of Medical Affairs and leaders in Clinical Program Operations, who're based in Germany (ideally North) and bring proven, transferable experience operating within the EU / at a Global scale.

The successful applicant will take ownership of the execution of oncology clinical trials across key European territories. You will lead on regional operations, drive country-specific strategies, and ensure tight integration with global development plans.

You'll need to bring experience in both managing and building a team of CRAs and MSLs, as team building / recruitment will be one of your core responsibilities.

This is a high-impact role for a strategic and hands-on leader with deep expertise in European regulatory frameworks, vendor oversight, and operational excellence in Phase I-III oncology trials. The ideal candidate brings strong leadership skills, cultural fluency, and a passion for delivering transformative therapies to patients across Europe.

Key Responsibilities:

Regional Clinical Leadership

Own clinical operations strategy and execution for oncology studies across Germany, France, and the UK.
Serve as the regional clinical operations lead on global study teams, ensuring EU input is integrated into study plans and timelines.
Continue to build a high-performing team of CRAs and MSLs, allocating resources as appropriate to various studies which are developing in parallel.

Cross-Border Operational Management

Align regional trial delivery with global timelines, regulatory milestones, and corporate objectives.
Coordinate and oversee CROs, vendors, and clinical site activities across the region, ensuring compliance with EU regulatory requirements (eg. EMA, MHRA, ANSM, PEI).
Stakeholder Engagement & Team Management
Lead a growing team of Clinical Operations professionals (particularly CRAs and MSLs) in Germany and across Europe, fostering accountability, collaboration, and high performance.
Build strong relationships with clinical sites, investigators, and European KOLs to support patient recruitment and study awareness.

Process Innovation & Compliance

Promote adoption of digital trial technologies and patient-centric tools to enhance trial efficiency and data quality.
Ensure full compliance with GCP, ICH E6 R2, and national regulations (e.g., GDPR, EU CTR).

Risk, Budget & Performance Oversight

Identify operational risks and develop mitigation strategies across different regulatory and healthcare landscapes.
Monitor trial budgets, ensure resource optimisation, and track KPIs for regional performance.

Required Qualifications

Bachelor's or advanced degree (PhD/Masters) in Life Sciences, Pharmacy, Nursing, or related discipline.
+10 years of experience in clinical operations within pharma or biotech, with significant experience managing Phase I-III oncology trials in Europe.
Proven track record of leading multi-country European trials, with deep operational knowledge of Germany, France, and the UK.
Strong understanding of EU regulatory bodies, ethics committee submissions, and local health authority requirements.
Experience building and managing large teams of CRAs and MSLs
Demonstrated ability to lead teams, manage vendors, and drive cross-functional collaboration.
Excellent communication skills in English; fluency in German or French is a strong plus.
Willingness to travel up to 30% across key European regions.

Preferred Attributes

Experience working in a biotech or early-stage company environment.
Familiarity with the EU Clinical Trial Regulation (EU CTR 536/2014) and GDPR compliance in clinical research.
Background in implementing decentralised clinical trials or hybrid study models in Europe.
Effective in navigating cultural nuances and healthcare systems across the EU.

What's on offer?

A chance to directly shape the future of cancer treatment in Europe.
Competitive compensation, including salary, bonus, and equity.
Flexible remote work structure with regular engagement across international teams.
A collaborative, science-driven culture with a commitment to innovation and patient impact.

Apply today, and reach out to Adam Akhtar - iO Associates, for further information!