Director Early Nonclinical Development

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

JOB TITLE: Director Early Non-Clinical Development

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.

 

Director Early Nonclinical Development

The Director Early Nonclinical Development will head efforts that can include contributions to Lead Selection and will include Lead Optimisation and Early Development of RNA-peptide conjugates. The best candidate will provide strategic and tactical leadership to the Research and Development programs. The best candidate demonstrates strength in communication and team leadership in a role that is broadly engaged across the organisation. In this position you will bring strong early-stage drug development experience and the ability to build and deploy tools and best practices to ensure the successful execution of R&D programs at a rapidly growing organisation. You will guide programs through a multitude of stages including taking a concept with excellent basic science, and with proof of principle for the mechanism at minimum at the conceptual stage, and put in place and execute the strategy for lead selection, characterization and conduct key aspects of lead characterization as part of key non-clinical research and early developmental milestones and decision points, and as a critical member of the team

 

Responsibilities

  • Take command of early development efforts to ensure a thorough understanding of concept, mechanism and available information
  • Interface with the early research team from the discovery stage so as to gain an understanding of all the evaluations that have been conducted. Create appropriate selection criteria to assist in lead selection, and then select lead and back-up molecules if needed, by considering and executing best approaches including but not limited to
    • In vivo PD and / or efficacy evaluations
    • Duration of effect and high-level distribution-effect-time curves, if and as appropriate
    • Tolerability and other on- and off-target evaluations, if and as appropriate
  • Narrow down, through in vitro and in vivo efforts including efficacy, tolerability and potential early PK-biodistribution, and other screening toward a lead candidate
  • Conduct extensive lead candidate characterization that will be foundational for non-clinical development
  • Hold deep command of efforts that include vitro and in vivo outcomes from the conceptual level through to proof of concept either via efficacy or PD models in vivo
  • Interface with early-stage CMC to educate efforts through appropriate in vitro and in vivo assays so that CMC improvements can run ahead
  • Strategize, plan, put in place, and execute the appropriate selection funnels for going from lead candidates to lead selection
  • Narrow down, through in vitro and in vivo efforts including efficacy, potential early PK and other screening toward a lead candidate
  • Interface with CMC to inform CMC efforts and optimization through appropriate assay-based feedback
  • Provide adequate expertise and support for bioanalytical assay design and development
  • Design and contribute to, and drive strategies to inform and advance non-clinical research and development to deliver candidates for clinical development as part of overall program strategy
  • Create and own the early non-clinical development plan in partnership with functional leaders in clinical and regulatory development as an integral part of the program strategy
  • Interface with functional and cross-functional leaders, especially with the early research scientific project leaders to foster high-performing teams through the creation of team norms and operating principles.
  • Facilitate effective, science-based business decisions including scenario planning, highlighting all potential downstream impacts of strategic decision making
  • Serve as a spokesperson for programs and remain accountable for team deliverables and value creation
  • Provide leadership around the design, execution, interpretation, and reporting of all contributing functional disciplines along with the functional leaders
  • Proactively identify and communicate risks in the project timelines regarding key milestones and deliverables and work closely with the scientific and functional leaders to mitigate downstream impacts
  • Work with project management to ensure alignment and provide leadership for budgets and timelines
  • Prepare and present progress reports and ad hoc reports, as required
  • Responsible for the conduct and deliverables of program meetings

 

Qualifications

  • MD, PhD, or PharmD and 5+ years of necessary biotech/pharma experience, or other university degree in a scientific discipline with 10+ years of necessary biotech/pharm experience
  • Strong understanding of the scientific basis for development programs strongly desired
  • Adequate understanding and know-how for being able to take compounds from discovery and ensuring proper lead molecule selection and lead characterization
  • 4+ years of experience leading multi-disciplinary research and non-clinical development programs highly preferred
  • Demonstrated leadership skills, has an easily recognized executive presence, and is a proven relationship builder who is effective via influence
  • Deep experience working with multi-disciplinary teams
  • Previous experience leading successful scientific programs that have progressed to clinical studies from discovery or early research
  • Proven track record of effective interpersonal and communication skills with ability to develop strong positive relationship with all levels of the organization.
  • Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
  • Requires a strong understanding of overall drug development strategies, spanning across all critical early-stage efforts
  • Working knowledge of IND enabling work as well as capability of contributing to all relevant IND sections including but not limited to module 2 and module 4

Applications close 20 October 2021 

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