ProTA Therapeutics is a newly established Australian private company developing immunotherapy based treatments for food allergy. The company’s lead product based on technology spun out of the Murdoch Childrens Research Institute, is under development as a treatment for the most common cause of life-threatening anaphylaxis, peanut allergy.
The company seeks to build its development capabilities to manage the transition from Proof of Concept to Phase III clinical development and cGMP manufacturing. The successful candidate will lead, direct and manage the product development process within the company, working closely with partners, regulatory consultants, CRO and CMO companies. A hands on approach is required to develop a CMC package, a regulatory strategy to guide clinical development and documentation for the FDA, TGA and European regulatory bodies.
The successful applicant will be a key member of the Executive Management team, working both independently and as part of a small multidisciplinary team. The ability to shift effortlessly from strategic planning and leadership functions, to hands on performance will be required for success in this role. A capacity to communicate with individuals across disciplines and at all levels in the organisation are essential, as well as the ability to work harmoniously within a small team environment.
Experience with production of pharmaceutical products in a laboratory or manufacturing operation that complies with cGLP/cGMP would be highly regarded, as would knowledge of international regulatory and clinical requirements, including FDA, TGA and EMA.
For a confidential discussion about this role, or to obtain a position description, please contact:
Dr. Suzanne Lipe, CEO ProTA Therapeutics
Applicants will be required to email their resume and covering letter providing relevant key skills and experience, prior to the closing date of 27 April, 2017.