Clinical Research Project Manager

PYC Therapeutics is an RNA therapeutics company using our world leading Cell-penetrating peptide (CPP) technology to create CPP-antisense oligonucleotide therapeutics for a range of severe rare disease. Our lead program is an intravitreal CPP-ASO for the treatment of a rare genetic eye disease called Retinitis Pigmentosa, the leading of childhood blindness.

We are seeking a highly motivated individual to lead, and project manage our lead program from pre-clinical to IND submission and into the clinic as our Clinical Research Project Manager. This is a rare opportunity to be a part of team taking a drug from discovery to market for a severe and unmet need with a ground break technology – both CPPs and ASOs. The role would integrate closely with our lead molecule’s inventors; Prof. Sue Fletcher (inventor of Eterplirsen – world’s first approved therapy for Duchene Muscular Dystrophy) and Dr. Fred K. Chen (world leading ophthalmologist with a focus on rare genetic retinal dystrophies).

The duties would focus on working with our existing team covering CMC, Toxicology and Pharmacology; reporting to our future CMO (and in the interim the CBO) to ensure a smooth and effective path to the clinic for our lead program. As a small drug development company PYC will be leveraging world best CROs and the role would include co-ordination of the CRO responsibilities and interaction with the PYC team.

The role would be based in Perth, Western Australia at our research labs at the Harry Perkins Medical research institute at Sir Charles Gardener Hospital. The role would entail some travel to the US, and the possibility of relocating to the US (Boston) after 1 year in the role. PYC is happy to discuss transfer packages and visa’s for non-Australian applicants.

Key Responsibilities:

• Management of regulatory submission process from initiation to approval for RNA therapeutics products, including preparation and submission of all new INDs (all IND Modules), study protocols, investigator brochures and other reports
• Review and preparation of all regulatory submission documents for completeness and quality in accordance with US regulatory agency requirements and standards
• Work in collaboration with the PYC leadership team on preparation, review and submission of regulatory documents and regulatory interactions
• Knowledge of Phase I clinical trial filing requirements, including requirements for protocol submission, review and reporting for ophthalmic trials
• Interaction with PYC partners, consultants and vendors regarding various regulatory, contracting, and operations matters

Qualifications:

• BA/BA degree required in Biology, Science or related discipline, Masters/PhD preferred
• 5 years of relevant experience
• Working knowledge of U.S. FDA regulatory system
• Ophthalmology experience highly helpful
• High level time management and organization skills
• Excellent written and verbal communication skills
• Knowledge of current and developing clinical research trends
• Sound interpersonal skills and ability to supervise others
• Ability to work independently and display initiative
• Ability to identify problems and develop solution

Job Type: Full-time

Salary: $140,000.00 to $160,000.00 /year

Experience:

• Clinical and regulatory (for drug development): 5 years (Required)

Education:

• Master’s (Preferred)

Work authorization:

• United States (Preferred)

Work Location:

• Multiple locations

Benefits:

• Health insurance
• Flexible schedule

Schedule::

• Monday to Friday