Job opportunities

Clinical Trial Operations Manager

Catapult Therapeutics is a privately held Dutch biotech company developing CAP-100 – an innovative first-in-class humanized anti-CCR7 antibody.

Catapult Therapeutics was established in 2015 as a joint venture between Spanish and Dutch partners. Catapult is founded on the discoveries of Dr Cecilia Munoz and her group at Hospital La Princesa in Madrid. They identified and validated CCR7 as a therapeutic target for leukemias and lymphomas. Technology of Dutch biotech company Pepscan made it possible to generate antibodies against human CCR7.

The chemokine receptor CCR7 is over-expressed in many cancers, and high CCR7 expression is associated with poor prognosis and short survival in hematological and solid malignancies. Preclinical studies have shown that the anti-CCR7 antibody can prolong survival and inhibit cancer cell migration in multiple animal models of B-cell and T-cell lymphomas.

CAP-100 has a uniquely differentiated mechanism of action, which is complementary to current standard of care treatments for hematological malignancies. Thus, CAP-100 is a potential monotherapy and can be used in combination with current standard treatments.

Catapult  is currently finalizing the preclinical development of CAP-100, with IND submission planned in Q4 2020.  The preparations for the start of the first study in patients are ongoing.

 The opportunity

Catapult Therapeutics is currently entering the clinical trial phase 1. To realize our ambition, we are looking for a hands-on clinical trial operations manager with proven knowledge of all aspects of clinical operations, preferably in oncology.

The basic responsibility is to deliver and execute the Catapult clinical development strategy for CAP-100 in a cost effective, safe and regulatory compliant fashion.

Proficiencies

The ideal candidate with life science background has a sound understanding of the pharmaceutical development process and has proven clinical trial experience. The candidate has a good understanding of stakeholder management, is accountable as project manager, and is thrilled by being in the frontline of breakthrough developments in cancer therapies. It’s a great advantage if the candidate has led the successful early clinical development of a new product.

Your responsibilities

• Ensuring projects are conducted according to defined scope, quality, budget and timelines.
• Oversight of Contract Research Organizations (CROs) and other vendors appointed by Catapult for the conduct of clinical trials
• Coordination of investigational medicinal product supply
• Co-monitoring of investigational sites to assure that clinical research is being carried out in full compliance with relevant requirements.
• Participation in development and review of clinical documentation and relevant clinical Quality Management System and conduct of vendor qualification audits.
• Arranging for submission and approvals by ethics committees and competent authorities together with regulatory affairs staff
• Representing clinical operations in the overall Catapult project team.
• Participation in the writing and review process of medical sections of regulatory documents for EU and US applications; assisting team with preparations for regulatory agency meetings and reports.

Your education, skills and experiences

• Degree in (bio-)medical, biological, biotechnology sciences or equivalent by experience; MSc preferred.
• 5+ years’ work experience as a CTM or equivalent for pharmaceutical/biotechnology company or CRO.
• Experience in oncology or immunotherapy is highly desired.
• Understanding of clinical trial methodology and operations
• Must be able to work on multiple simultaneous tasks with limited supervision
• A self-motivated, energetic and detail-oriented professional with an affinity for project management
• Result oriented and proactive attitude with a can-do mentality. High standards, self-starter.
• Open-minded and creative problem solver who is punctual, takes ownership, and can deal with competing priorities and challenges
• Demonstrated capabilities in building relationships based on trust, engagement and long-term commitment

Your profile

• Entrepreneurial
• Excellent interpersonal skills
• Excellent oral and written communication skills (English)
• Project management skills
• Passion for clinical excellence
• Sound decision making capabilities
• Willingness to travel abroad (mainly US/EU)

What we offer

The position (32-40 h/week) offers an opportunity to work within a small team, with great autonomy and entrepreneurial, science-loving colleagues, all of whom are committed to improving the lives of patients.

Catapult Therapeutics’s offers an informal ambitious working environment. We offer a market conform salary and a good pension plan. The right candidate will be welcomed enthusiastically.