Clinical Operations Senior Director M/F

À propos de nous

TreeFrog Therapeutics is an innovative biotech aiming to bring cell therapies to millions of patients, thanks to C-StemTM technology, which was developed to cultivate and differentiate stem cells on a large scale, a world 1st. Since its incorporation in 2018, Treefrog Therapeutics has raised more than €74 million and is experiencing strong acceleration thanks to its over 150 froggies team.

Mission Context

TreeFrog continues to grow and is one step closer to its goal of bringing cell therapy for patients! The next step in TreeFrog’s evolution will be to sponsor its own clinical trials of potential new cell therapies. This creates an exciting opportunity for an experienced Director of Clinical Operations (DCO) to build and lead a new operational function ready to start the first sponsored clinical trial in 2026. The clinical development is at an early stage in TreeFrog, involving lots of interaction with R&D, preclinical, medical device, and regulatory/quality teams. It requires strong experience to develop early clinical activities while ensuring alignment with the company strategy and patient’s needs.

Mission

The Director of Clinical Operations, reporting directly to the Chief Medical Officer (CMO), will design and build out TreeFrog’s Clinical Operations function. He/She will manage all aspects of operational execution of clinical trials and 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 Regulatory and Quality team to ensure compliance with clinical trial requirements and incorporate GCP compliance into the existing quality management system.

Responsibilities:

1. Build and lead TreeFrog's clinical operations strategy and function.
2. Lead the planning and coordination of the operational clinical activities with the different teams.
3. Partner with the quality team to develop the GCP area of the quality management system.
4. Lead the operational execution of sponsored early phase clinical trials.
5. Drive assessment, selection, engagement, and oversight of vendors and clinical sites related to the operational conduct of clinical trials.
6. Produce all clinical trial documents (clinical study reports, etc.).
7. Be responsible for authoring and application of TreeFrog’s clinical SOPs in accordance with ICH/GCP guidelines, all applicable laws and regulations.
8. Contribute to the authoring of regulatory documents (including IB, Protocol, Trial Masterfile…).

Profil

Since a bachelor’s degree in life sciences or related discipline, you have accumulated at least 10 years’ experience in clinical operations as a trial leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment. The first and most prominent clinical project on which you will be focused will be the development of our Parkinson disease cell therapy program, thus, experiences in Parkinson, neurology, and/or ATMP is a plus.

Experience with medical writing, CEPs/CERs, and clinical investigation reports is required. A track record of effective oversight of CROs and third-party vendors is essential. Good knowledge of regulation in EU/US and experience in interactions with FDA, EMA, and ANSM is a plus. In-depth knowledge of essential regulatory guidelines and ICH/GCP, ISO 14155 standard, MDR 2017/745, and GDPR are required as well as previous participation as a subject matter expert or senior leader in a regulatory authority GCP inspection.

We are seeking a candidate with the following skills:

• High degree of autonomy.
• 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.

If this appeals to you, we look forward to receiving your application and join us as a Froggy!

Conditions

• Location: Office based preferred (Rue Thomas Edison - Canéjan 33610) or Remote in Europe although in-person attendance will be expected regularly.
• Travel: The DCO will travel internationally to investigator sites & meetings, congresses, and vendor sites as appropriate to build the function and operationalize the trials.
• Start date: Q2 2025.
• Benefits:
  • Moving assistance: If you don't live near Bordeaux, we can help you find accommodation via a financial package.
  • Mobility sustainable: We promote soft mobility through our partner Bee-cycle, which offers a solution to help our employees purchase a bike, and Karos, which is a car-sharing solution, and we reimburse all transport-related season tickets up to 50%.
  • Ecological commitment: TreeFrog wants to save lives, but also help save our planet. Several of our employees are working together to reduce our waste and carbon emissions. For example, we have a zero-waste connected fridge.
  • Sport: Crossfit & yoga classes are held several times a week on our premises.
  • Food: We offer luncheon vouchers worth €9.80, 60% of which is paid by the employer. We also have several delivery solutions for quality, low-cost meals on our premises.

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Location: Bordeaux, FR

Posted Date: 12/21/2024