Nanologica AB is looking to recruit a Clinical Project Manager for driving the clinical development of our own products as well as co-development programs. The role encompasses managing multiple development projects, building and maintaining relationships, providing guidance on clinical/regulatory issues and exploring new application areas and business opportunities. We are looking for someone with an entrepreneurial spirit, hands-on attitude and strong interpersonal skills to join our enthusiastic team. At Nanologica we offer a multi-cultural, fast-paced working environment and opportunities for you to grow individually and professionally. Come join us on our journey!
The position is full time and based in Södertälje. We will interview candidates continuously and welcome your application today.
As a Clinical Project Manager you will be responsible for planning, executing, and reporting of clinical studies throughout the life cycle of Nanologica´s products, focusing on productivity, delivery and quality as well as managing risk and contingencies proactively and lead problem solving efforts.
Main responsibility areas include:
Manage all activities related to projects in clinical development phase in compliance with GCP/ICH guidelines and relevant SOPs, including budget, documentation, reporting and communication with involved parties.
Identify unmet medical needs and challenges of current treatment options to match with potential benefits of the Drug Delivery technology. Support activities for establishing innovation strategies, identifying partners and opportunities and advancing technology- or product development. Investigate and prioritize projects according to clinical benefits, match with technology, feasibility and market value. Lead multi-disciplinary internal/external project team activities.
University degree or PhD degree in life sciences. Preferably 3+ years of industry experience, (e.g. in clinical project management). Understanding of drug product development and multi-project planning and coordination. Strong understanding of ICH/GCP guidelines and relevant regulatory requirements. Project management skills and excellent written and verbal communication skills are necessary.
Experience in nanotechnology, drug delivery and/or material science and in managing of vendors and CROs. Experience with product development according the 505(b)2 regulatory approval pathway in the US.
Nanologica was founded in 2004 and uses a unique knowledge in the field of material sciences to fulfill the vision of providing better and cheaper medicine through nanoporous silica. Two business areas within life science, where the knowledge is applied, has been formed - Drug Delivery and Chromatography.
Within Drug Delivery, a proprietary technology to deliver the right dose of pharmaceutical drugs to the right place at the optimal time has been developed. The technical platform has been evaluated in several collaborations with big pharma companies and a pipeline of projects where reformulation of existing drugs will address limited therapeutic options for patients has been built, with a focus on the benefits for the patient. Several strategic partnerships have been entered into and we continue to evaluate business opportunities to accelerate innovation and implementation of our technology into clinical stage products.
The technical platform has now taken the step into a first commercial license agreement, at the same time as an in-house project within the field of gastroenterology, with formulation development and preparation of the clinical phase, has started. More information is available at www.nanologica.com.