Job: Director, Clinical Operations & Medical Affairs

Prota Therapeutics is an Australian private company developing immunotherapy based treatments
for food allergy. The company’s lead product based on technology licensed from the Murdoch Children’s Research Institute, is under development as a treatment for the most common cause of
life-threatening anaphylaxis, peanut allergy.

The Role
The company seeks to build its development capabilities to transition from Proof of Concept to
Phase III clinical development and cGMP manufacturing, and to build industry presence to
prepare for investor and corporate partnering activities. The successful candidate will lead, direct
and manage the clinical product development process, working closely with the CEO and CSO
and with external partners, consultants, CRO and CMO companies. The incumbent would be
expected to have a hands-on role designing, improving and implementing systems the company
would use in the delivery of its development program.

Duties and Responsibilities
• Manage key clinical operations to develop products for human clinical use.
o Provide strategic and operational input into clinical development plans and study
protocol design
o Identify and assess study centers and investigators and initiate study sites to
participate in clinical trials (USA and Australia)
o Appointment and management of a clinical CRO.
o Develop and implement clinical SOPs
o Oversee investigational study product inventory and distribution to sites.
o Contribute to regulatory agency documentation as required
• Manage product development related publications and communications.
o Monitor and report on clinical publications, industry announcements and
consumer media commentary.
o Develop a communication plan that aligns publication of data at scientific
meetings with data analysis and media announcements
o Manage communications with healthcare professionals and respond to enquiries
from members of the public.
o Assist with development of corporate partnering and business development slide
decks and briefing packs
o Lead and manage the establishment of a Prota corporate website.

Pre-Requisite Qualifications and Capabilities
• A post graduate Master or PhD degree in a related life sciences discipline
• A minimum of 10 years’ industry experience in product development and clinical
research, mostly in leadership roles
• Experience with US FDA regulated pivotal Phase 3 clinical trials gained at a biologics or
pharmaceutical development company is expected.
• Comprehensive knowledge of Good Clinical Practices (GCP), ICH Guidelines, FDA and
TGA regulatory body requirements.
• Prior experience in allergy-related trials would be particularly advantageous.
• Proven management experience with strong leadership and motivational capabilities.
• Exceptional organizational skills and project management capability.
• Excellent oral and written communication skills

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
organization is essential, as well as the ability to work harmoniously within a small team

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 22 May 2018.


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