Preclinical Development Lead
Company Description
RegMed XB (Regenerative Medicine Crossing Borders), was founded in 2017 as a virtual institute of Dutch and Flemish[FL1] public (governments and universities) and private (health foundations and companies) partners that are working together to develop regenerative medicine solutions to cure chronic diseases. RegMed XB believes that when researchers, patient organizations and entrepreneurs work side by side, they stand the best chance to bring the most impact to patients and society at large. There are currently four “Moonshots” to cure patients with end-stage kidney failure, type 1 diabetes, osteoarthritis and cardiovascular disease. Beyond its scientific objectives, RegMed XB is also active in public-private partnerships to integrate research and valorization to shorten the time-to-patient and translate research results into new businesses.
In order to continue their development, RegMed XB is looking for qualified talents. Be a part of the development of unique products in the field of Regenerative Medicine and be the next :
Preclinical Development Lead
Be at the forefront of medical innovation and collaborate closely with key stakeholders, including patients and clinicians, drive the advancement of new treatments as part of RegMed XB Moonshot Programs and have a crucial role in medical innovation, working alongside Project Managers, Business Developers, and the Medical Director.
Position
- Focus on the (pre)clinical development of specific regenerative medicine products.
- Guide, prepare, and assemble comprehensive dossiers, including Chemistry, Manufacturing and Controls; Investigational Medical Product Dossier; and Investigational Medical Device Dossier and manage submissions to regulatory bodies to obtain Clinical Trial Authorization.
- Assess existing product dossiers, perform gap analyses, and prepare dossiers for consultations with regulatory bodies.
- Lead the (pre)clinical development of new products in Regenerative Medicine as part of RegMed XB Moonshot Programs, focusing on Advanced Medical Therapeutic Products (ATMPs), in collaboration with the investigational teams, patients, clinicians, and other key stakeholders.
- Manage and collaborate closely with Moonshot Project Managers and report to the Chief Medical/Scientific Director to align and advance project goals.
Requirements
- You hold an advanced degree in Bioengineering, Molecular Biology, Pharmacology, or another related field within the life sciences.
- You have 7 to 10 years of experience in the industry, focused on developing innovative patient products, and have demonstrated successful interactions with key regulatory agencies like the EMA, FDA, and national competent authorities.
- You possess expertise in medical product development, having co-led the creation of product dossiers and the preparation of submissions to relevant regulatory authorities.
- You have actively engaged in technical discussions during scientific advice sessions with National Agencies, the EMA (CAT), and/or the FDA. Experience with Advanced Therapy Medicinal Products (ATMPs), Class II/III Medical Devices, or combination products is a plus.
- You have a solid understanding of the challenges involved in the clinical translation of innovative medical treatments, particularly in manufacturing.
- You possess strong leadership skills, consistently meet deadlines, and actively contribute to problem-solving. You thrive in collaborative environments with motivated teams and have a keen interest in the emerging field of Regenerative Medicine.
- You are willing to work mostly from home and to travel within the Netherlands and Belgium for day trips, facilitating direct engagement with project partners and stakeholders.
- You speak English fluently and can communicate in Dutch easily.
Other information
Interested?
RedMed X offers a stimulating work environment where you can apply your skills and actively contribute to the company's growth.
To apply, send your resume to the following email address: shera.janati@key4nova.com.
