Preclinical Development Manager ATMP (ref. ATP-2024-556)

KU Leuven Research & Development (LRD) builds bridges between science and society. As a technology transfer service of the KU Leuven Association, we guide scientists to put their research results at the service of society, the economy and the living environment. Our multidisciplinary team has a solid experience in setting up research collaborations, protecting and licensing intellectual property and establishing spin-offs. Through a unique network, we connect researchers with companies, but also with governments, investors and other organizations, so that we can respond together to the needs of society. In this way we are building a world ready for tomorrow, with today's excellent research. In the framework of the building of a unique translational hub named Multithera for the development and clinical translation of Advanced therapy medicinal products (ATMPs) LRD is looking for a CMC manager ATMP.

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Responsibilities

The CMC Manager ATMP will guide stakeholders in devising strategies to evaluate the non-clinical aspects (pharmacology and toxicology) of candidate cell and gene therapies within the Multithera platform. He/She will plan studies to adhere to regulatory requirements, conduct non-clinical gap analyses, and represent Multithera and collaborating partners in Regulatory Agency Scientific and Innovation meetings. The CMC Manager ATMP will devise and execute optimal non-clinical strategies while delivering top-quality non-clinical and supplementary regulatory submissions for each program, in collaboration with other members of the Multithera group and its stakeholders.

Key Accountabilities:

• Evaluate the non-clinical safety aspects of candidate cell and gene therapy programs, performing gap analyses for external collaborators and clients;

• Offer ad-hoc non-clinical safety support and guidance on program development to partners and clients across a wide range of advanced therapy medicinal products;

• Plan, design, and execute non-clinical studies sponsored by Multithera or its partners, including GLP regulatory toxicology;

• Manage contract providers' selection and monitoring, ensuring compliance with project plans and budget;

• Compose non-clinical sections of regulatory documents for scientific advice meetings and clinical trial applications. Represent Multithera and collaborating organisations in meetings with associated health technology assessment (HTA) groups (both local and international);

• Support business development efforts through participation in meetings, conferences, proposal preparation, and grant application writing, meeting high standards and tight deadlines;

• Cultivate and maintain solid relationships and communication with vendors and collaborators;

• To review literature and attend conferences to keep abreast of developments in ATMP development, with a strong focus on pharmacology / toxicology;

• Create and review protocols and author study reports for non-clinical studies.

Profile

• You have a Master or PhD degree in Biomedical Sciences; Pharmaceutical sciences; (Bioscience) Engineering or equivalent through experience;

• You have proven track record in handling non-clinical aspects of innovative cell and gene therapies;

• You are familiar with animal models for efficacy, pharmacology, and safety assessment and evaluation;

• You have experience in preparing regulatory documentation and engaging with regulatory agencies;

• Understanding of regulatory requirements for bioanalytical assay development and validation is advantageous;

• You have background in working within a GxP compliance environment;

• You are proficient in creating study protocols and reports;

• Knowledge of the academic grant application process would be a plus.

Your core competencies:

• Highly motivated and driven to support the growth of the cell and gene therapy industry, with a strong desire to build a successful career in the sector;

• Expertise in ATMP development and a broad understanding of other therapeutic modalities;

• Excellent interpersonal, communication, and emotional intelligence skills;

• Proficient in standard Microsoft packages;

• Proactive and adaptable approach to work assignments, with a commitment to learning and professional development;

• Resilient, organized, and detail-oriented, able to manage multiple tasks and priorities in a fast-paced environment;

• Experience in managing research and development projects in academic or industry settings, with proven project delivery and management skills;

• Strong ability to work independently, take initiative, and collaborate effectively within a team;

• Ambitious and results-oriented, with exceptional external-facing skills to build relationships;

• Effective problem-solver, able to evaluate complex situations and provide professional solutions;

• Confident public speaker, coach, and mentor, with a successful track record in scientific collaborations and publishing;

• Committed to staying up-to-date with industry knowledge and best practices;

• Willingness to travel.

Offer

• We offer a full-time position with a permanent role in an innovative environment in the center of Leuven;

• A salary matching the job responsibilities and taking into account your experience;

• Additional benefits including free hospitalization and group insurance, additional holidays, bicycle allowance, free public transport and ecocheques;

• A hybrid working environment and teleworking allowance.

Interested?

For more information please contact Mrs. Lieve Mommaerts, tel.: +32 16 37 76 89.

You can apply for this job no later than December 05, 2024 via the online application tool