NOVADIP BIOSCIENCES (www.NOVADIP.com) is an innovative biotech company expert in the development of novel regenerative medicines. This human-sized structure is a leader in new generation therapies for hard & soft tissue reconstruction from autologous adipose stem cells.
NOVADIP BIOSCIENCES shows the ambition to grow to a worldwide class, with a successful closing of a 28M€ fund raising. Its main objective for the coming years is to develop its portfolio of products and to perform clinical validation and process industrialization of its main compounds.
NOVADIP BIOSCIENCES is a French/English-speaking work environment based in Mont-Saint-Guibert (close to University of Louvain-la-Neuve and Brussels area), Belgium, Europe.
In order to support our clinical development in the USA, we are actively looking for a (m/f):
As a Medical Manager, you are part of the Medical Department consisting of the Chief Medical Officer, a Compliance Manager, 2 Clinical Project Managers, 2 Clinical Research Associates and a Clinical Research Assistant. You closely collaborate with them.
Your main responsibilities are as follows:
- Design, contribute and write new study protocols and documentation related to clinical trials (IMPD/IND, investigator brochure, sponsor master files, patient informed consent, CRF, monitoring plan, safety plan /DSMB…) and contribute to the design of clinical development plans.
- Develop and maintain a network of medical experts in the field and work in close collaboration with internal departments (i.e. R&D, Regulatory Affairs, Manufacturing, logistics…).
- Identify, screen, select, and initiate contacts with clinical sites, CROs, and other sub-contractors in the USA for the future trials in collaboration with clinical team.
- Set up pharmacovigilance program (standalone or in collaboration with CRO).
- Manage the interactions with ethics committees.
- Monitor trials from a medical point of view, together with internal staff and clinical sites personnel.
- Review incoming clinical data, and write medical reports or any other scientific files in collaboration with the Chief Medical Officer.
- Facilitate communication flow between the clinical sites, CROs and Novadip.
- Share your knowledge with the teams in order to overcome scientific, operational, regulatory, marketing, financial and strategic challenges within the company.
- Active participation in training/coaching of operational teams involved in clinical trials (internal and external).
- Report to the Chief Medical Officer.
- MD, PhD in Medical Sciences or Master in sciences or related field.
- Min. 5 years of experience within either a CRO or a Pharma/Biotech/Medtech company. Experience in cell therapy is a great asset.
- In depth understanding of processes related to clinical development plans, clinical trials, and superior knowledge of IHC-GCP.
- Interest in basic sciences and translation of medical science in new clinical trials protocols.
- Good communication skills with both clinical and non-clinical contacts.
- Excellent attention to details and established organizational skills.
- Demonstration of flexibility, professionalism, good interpersonal skills and managerial skills.
- Fluency in written and spoken English is required. Good level of Dutch or French is a plus.
- Willingness and ability to be based in USA or to travel frequently to the USA.
- To be in the possession of a full driving license.
A diversified full-time permanent position within a high-potential innovative biotech company.
- To work in a human-sized, dynamic, respectful and professional environment.
- The opportunity to take part in a challenging scientific and business growth.
- Varied contacts inside the company and with the biotech/pharma sector.
- An attractive salary package in line with the position responsibilities and your experience.