Director Clinical Operations

PYC Therapeutics
Perth
CBD, Inner & Western Suburbs
Science & Technology
Biotechnology & Genetics
Full time
Posted 22d ago

JOB TITLE: Director Clinical Operations

 

About PYC Therapeutics

PYC Therapeutics is a drug-development company offering a new generation of RNA therapeutics to provide solutions for unmet or underserved need in disease.

Our RNA therapeutics have two key technologies that constitute our therapeutic approach. These technologies form an integral part of our investigational molecules: specific and precise RNA-targeting oligos that are covalent linked to peptides that can enhance the delivery of the molecule to relevant cells and tissues within the targeted portion of the body.

 

General Description

The Director, Clinical Operations, will support clinical development programs for PYC Therapeutics, specifically within Clinical and Medical efforts by execution of clinical operations in these programs and for deliverables in partnership across the organisation; with external vendors; and with external academic and private clinician-researchers; with patients and patient advocate organizations; and with collaboration partners. The incumbent will report to the Chief Development Officer.

As a leader in the organization, the incumbent will be accountable to develop clinical operations strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will play a key role the establishment and growth of Clinical Operations functions to assure best-in-class global capabilities and execution.

 

Education

A degree from an accredited college or university, or an equivalent level of professional, clinical and/or scientific education, training and experience is desirable

Experiences and requirements 

  • Minimum of 10+ years of experience and success within other biotech/pharmaceutical/contract companies is required with college or university degree; 15+ years without such credentials from an accredited college or university degree
  • Biotech/pharma or CRO experience needs to be at the clinical trial study management level for at least 5 years
  • Previous participation in a clinical operations program is essential, including involvement in all stages of clinical trials, that is from start up to clinical study report, in principle having taken at least one clinical trial through from start to finish. Involvement at various stages, if not entirely, in multiple clinical trials is the preference
  • Experience in Ophthalmology clinical operations, and specifically, retinal diseases required
  • Direct experience with rare ophthalmic disease is preferred
  • High level of both written and verbal communication; interpersonal, organisational, and cross functional collaboration skills
  • Knowledge of GCP and ICH Guidelines
  • Experience with the development and support of related SOPs and policies is expected
  • Experience handling each of the following parts of clinical trial management: clinical trial sites, vendors, independent reading/grading centres, interfacing or managing clinical supply logistics, and handling contracts, negotiations including initiation and close out of efforts is required
  • Flexibility to work with colleagues in a global setting
  • Able to engage in work-related travel 
  • Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred

Applications close 20 October 2021 

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