Project Leader IBD
About The Position
A young and dynamic Israel-based microbiome company is looking for a highly-motivated, experienced Project Leader to lead a pre-clinical project through to the clinic. The successful candidate will have a strong scientific background and previous experience with regulatory processes and clinical stage projects. The candidate will have excellent interpersonal skills and managerial capabilities to lead the project within a matrix-like organizational structure while managing external CROs. The successful candidate will report to the Sr. Director Development.
· Manage one of BiomX’s leading programs. Leading a project at BiomX includes oversee of all activities related to the project at all levels, from the details of the science behind the product through the strategic planning and understanding of the market.
· Advancing a new drug to the clinic and eventually to patients is a team effort. Project Leader will lead and coordinate project related activities with different units within the company.
· Many activities are handled outside of BiomX. Project Leader will establish and manage outsourced activities with CROs and consultants.
· Development of a biological product requires constant handling of dynamic and unforeseen challenges. Project leader will constantly evaluate gaps in the program and provide solutions within the company and via external resources
· The market, the science and the therapeutic landscape are constantly evolving. Project leader will keep abreast of these changes and will serve as a knowledge resource within the company for the indications the project is aiming for.
· Manage development activities towards regulatory submission and clinical trials, including activities related to clinical assay development and CMC.
· Prepare and manage the project’s work plan and budget. Adjust and modify the work plan as required through the project’s life cycle.
· Be responsible for attaining project’s timelines in line with company’s needs
· PhD in Life Sciences, Biotechnology or equivalent with a minimum of 5 years of relevant industry experience in a similar position
· Previous experience in regulatory activities and submissions (FDA; EMA) and preparation and execution of clinical trials
· Ability to assess and prioritize multiple tasks and demands within an interdisciplinary environment
· Strong scientific background to evaluate and implement methods in transnational activities
· Excellent communication skills and interpersonal relationships
· Excellent organizational skills
Please submit your resume in English