Careers

The Company

Founded in 2008 and based in Berlin, 3B Pharmaceuticals (3BP) is a privately owned pharmaceutical biotechnology company, leading in the discovery and optimization of peptides for the development of tumor-targeted radiopharmaceuticals. The goal is the therapy and diagnosis of currently difficult-to-treat cancers. Expertise ranges from compound identification to early clinical development. 3BP is recognized as a major player in this highly specialized field.

Up until now, the company has outlicensed clinical candidates for further development, its molecules are currently being developed by pharma companies including Novartis, Debiopharm and Fusion Therapeutics.

The next step in 3BP’s evolution will be to sponsor its own clinical trials of potential new medicines. This creates an exciting opportunity for an experienced Director of Clinical Operations to build and lead a new operational function ready to start the first sponsored clinical trial in 2024.

The Role

The Director of Clinical Operations (DCO) will design and build out 3BP’s clinical operations function. They will oversee all aspects of operational execution of clinical trials. They will be accountable for planning and leading the studies to time, quality, budget, company standards and scientific requirements.

In addition, the DCO will work with the Quality team to incorporate GCP compliance into the existing quality management system.

The DCO will have previously led several clinical trials from design to completion, including selection and oversight of a full service CRO. They will have participated in at least one regulatory authority GCP inspection as a subject matter expert or senior leader and have experience of building inspection readiness into all operational processes. Extensive mentorship and support will be available, although the DCO should thrive with minimal direct supervision and a high degree of control over their own day-to-day activities.

The DCO should be excited and motivated by the opportunity to create a clinical operations function from the ground up. They will be comfortable operating at all levels during the set up period, from defining strategy to fulfilling the everyday operational tasks. They will be able to lead and inspire others including colleagues, vendors and clinical site personnel, and have a collaborative and open-minded style that fosters a supportive working environment for the team. A track record of applying experience and judgement towards development of an operations function, agile project decision-making and shared learning is essential.

 

Key Responsibilities

• Build and lead 3BP’s clinical operations strategy and function
• Partner with the quality team to develop the GCP area of the quality management system
• Lead the operational delivery of sponsored early phase clinical oncology trials
• Drive assessment, selection, engagement, and oversight of vendors
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations and 3BP’s SOPs
• Input into protocol development, regulatory documents and clinical study reports from a clinical operations perspective

 

Basic Qualifications

• Considerable clinical development experience that is equivalent to 10 years as a trial leader (at least 3 of them in the field of oncology) with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment
• Proven experience of effective oversight of CROs and third-party vendors
• In-depth knowledge of essential regulatory guidelines and ICH/GCP
• Previous participation as a subject matter expert or senior leader in a regulatory authority GCP inspection
• Strong leadership, influencing and negotiation skills
• Ability to establish and build internal and external relationships at all levels
• Excellent project and budget management skills
• Experienced in authoring patient facing materials, study procedures manuals, pharmacy manuals, and informed consent forms in English
• Highly developed communication skills
• Bachelor’s degree in life sciences or related discipline
• Previous experience in oncology is necessary, experience of clinical development of radiopharmaceuticals would be a plus, though not essential

 

Location and travel

The position could be office based or remote in Europe, although in-person attendance will be expected regularly. In addition, the DCO will travel internationally to investigator sites & meetings, congresses and vendor sites as appropriate to build the function and operationalize the trials.

 

Our Culture

• An open and appreciative corporate culture with a strong team spirit

• Attractive employment conditions in a growing company with flat hierarchies
• You work independently and autonomously
• Permanent employment, flexible working time model
• Potential to develop your role as the company grows

If this appeals to you, we look forward to receiving your application documents with details of your previous work, the earliest possible starting date and your salary expectations. Please send your application by email with the subject DCO to
jobs@3b-pharma.com.