VP Clinical Operations

Company Overview:

Currently working with an global biotech with multiple clinical trials that is expanding their executive clinical team.

They need a VP of Clinical Operations who understands proper clinical trial management. We need someone who can help identify and execute the best strategy to fast-track their Phase II and III trials. They also have a unique approach using immuno-oncology which has recently secured a global partnership with Big Pharma.

If you are a Clinical Operations leader who is passionate about oncology drug development, fast moving biotechs and are able to find the balance between strategy and execution - then would love to hear from you.

Key Responsibilities:

Strategic Leadership:

• Able to lead strategic and operational aspects of late stage clinical programs for solid tumors.
• Work with the C-Suite and other departments and help explain what is and is not possible. To help set realistic timelines but pushing the most from the budget, vendors and clinical time to maximise their PIII trials.
• Lead a small team of individuals (Trial Managers, CTAs, Consultants) and foster a culture of continuous learning and professional growth within the department.

Clinical Trial Planning and Execution:

• Lead the implementation and execution of clinical development plans for 3x Global Clinical Trials (PII/PIII, Solid Tumors).
• Oversee the planning, initiation, and execution of global clinical trials, from new Phase I through future late-stage submissions.

Vendor Management:

• Maintain ongoing relationships with external vendors, including clinical research organizations (CROs), central labs, and other service providers - we have good CROs in place already, we want to maintain this good relationship and maximise their effectiveness.
• Communication, answering questions, ensuring proper use of budget. You will set the expectations and the overal strategy, your CPM will be answering their questions and making sure they stay on track.

Regulatory Compliance:

• Ensure compliance with relevant regulatory guidelines, industry standards, and ethical practices in clinical research.
• Collaborate with Regulatory Affairs to support the preparation of regulatory submissions and interactions with health authorities.

Risk Management:

• Identify potential risks and issues related to clinical trial conduct and develop proactive mitigation strategies.
• Implement risk management plans to ensure the successful execution of clinical programs.

Requirements:

• Essential: Biotech, Pharma or CRO experience.
• Essential: Worked on global large scale trials (minimum Phase II, ideally PIII).
• Essential: Strong track record of Clinical Operations execution.
• Highly Preferred: Line Management Experience.
• Highly Preferred: Oncology Trial Experience.
• Mindset Needed: This is biotech (100 people) - must be willing to deal with fast changing role. Being able to work the strategy but also not afraid if certain SOPs are not in place yet - not afraid to be hands on when needed.
• Location: Must be France or Germany based.
• Visa Requirement: Must have current Full EU working rights.
• Language: English (German and/or French a plus but not essential).

Process and application

If you are interested you can apply simply by clicking onto this advert.

Or you can message or email me directly. All applications are strictly

Note - I also have open a Director position (similar company), if you believe this is too senior - do apply or connect with me anyway.

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