Our client is an innovative Belgian biotech company active in cell therapy. With a team of dynamic and Science-driven professionals, this biotech’s mission is to improve patients Quality of Life.
To strengthen the team, we’re looking for a (m/f):
Scientific Director – Non-Clinical Projects
As a Scientific Director, you report to the COO and the CSO and you are part of the R&D team. As a key member, you provide non-clinical advice and you ensure the execution of the non-clinical development strategy.
Your main responsibilities are:
- You design non-clinical safety plans that support clinical trials and marketing applications.
- You lead PK/PD and safety studies of potential new medicines.
- You maintain effective interactions with the research, pre-clinical development, clinical operations, manufacturing and regulatory affairs teams.
- You are a key player in writing regulatory documents including non-clinical sections such as IND’s, IMPD’s, CTA’s and BLA’s.
- You contract, monitor, review and sign-off on non-GLP and GLP studies conducted by various CRO’s.
- You lead and follow-up researches at CRO’s and take decisive actions.
- You regularly report projects evolution to the top management.
- You have a PhD in immunology, biology, biochemistry, pharmacology or medicine.
- You have 10 years industry experience in pharmaceutical or biotech companies.
- You have experience with biologics. Experience in ATMPs, and/or orphan-indication products development is an asset.
- You have a track-record of successfully managing non-clinical projects (safety, toxicology, pharmacology…) and of providing strategic oversight for R&D, preclinical and clinical study protocols, reports and publications.
- You have a good knowledge of GLP, GCP and regulatory requirements (FDA, EMA, ICH).
- You have strong organizational and interpersonal skills, with attention to details.
- You have excellent written and verbal communication skills, underpinned by the ability to present clear directions to teams within the organization and to external audiences.
- You have a positive, open, objective mindset and are flexible and open to change. You have critical thinking and you are assertive.
- A strategic and leading position within a high-potential innovative biotech company.
- The opportunity to work in a human-sized, collaborative and respectful environment.
- To take part in a challenging and cutting-edge scientific development program.
- An attractive compensation package in line with the responsibilities of the position and your experience.