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 in 2015. significant support of 9.4 million euros from the government of Wallonia. Its main objective for the coming years is to perform clinical validation and process industrialization of its main compounds NVD-001 and NVD-003 and to develop its other new products.
NOVADIP BIOSCIENCES is a French/English-speaking work environment based in Mont-Saint-Guibert (close to University of Louvain-la-Neuve and Brussels area in Belgium).
In order to support our team, we are actively looking for a (m/f): Product Development Director
As a Product Development Director, you lead scientific, non-clinical (in vitro and in vivo) and CMC activities. Reporting to the Chief Technology Officer, you implement the process development, product characterization and non-clinical strategy of the company.
You lead and provide strategic direction for the product development and ensure full compliance of quality. You are an insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive development plans. You are also responsible for leading and managing the SaT Team.
Your main responsibilities are:
- You lead pharmacology and safety studies of potential new medicines.
- You maintain effective interactions with the basic research, clinical operations, pharmaceutical operations, 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.
- Initiate the development of performance metrics on projects and studies
- You contract, monitor, review and sign-off on GMP, non-GLP and GLP studies conducted by various CRO’s.
- You follow up research at CRO’s and take decisive actions.
- You design CMC, product characterization and non-clinical safety plans that support clinical trials and marketing applications.
- You Achieve financial objectives by preparing budgets, scheduling expenditures, analyzing variances, and initiating corrective actions.
- You regularly report projects evolution to the top management.
- You have a PhD in life sciences (biology, biochemistry, pharmacology, medicine…).
- You have around 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 preclinical and clinical study protocols, reports, and publications.
- You have a good knowledge of CMC development strategy (process development and validation; product characterization).
- You have a good knowledge of GMP, GLP 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.
- You fluently communicate in English.
- 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.
Nous traitons votre candidature rapidement et de manière strictement confidentielle.