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Vice President/Consultant of Drug Development: Clinical Readiness

3 months ago

Sydney, New South Wales, Australia Psylo Full time

Who We Are

Psylo is a biotech company pioneering next-generation therapeutics to treat central nervous system disorders. Our mission is to extend the healing potential of psychedelics to a broader patient population. We use our computationally-enhanced drug discovery platform to develop novel compounds with optimized pharmacological profiles that overcome the clinical limitations of current treatments. Psylo is based in Boulder, Colorado and Sydney, Australia. Psylo won the Hello Tomorrow 2023 APAC Competition, was a Top 50 Global Startup in the SLINGSHOT 2023 competition and was named a Top 100 Innovator by The Australian Business Review.

About the Role

We are seeking a VP-level pioneer and leader in drug development who will drive early small molecule leads through later stage preclinical development and into clinical stages. This role will start as a part-time/consulting position with increasing hours and potential to transition to full time.

The Vice President/Consultant of Drug Development: Clinical Readiness will be responsible for advancing our programs, from lead ID through the IND filing. The candidate must be an entrepreneurial, highly motivated, and purpose-driven leader who is able to flexibly and efficiently lead multi-disciplinary teams at various stages of discovery. The successful candidate will have a track record of accomplishments in drug development as well as demonstrated high-impact research in industry. The candidate must exhibit excellent leadership, project management, and strong collaboration and communication skills and should be ready to champion new ideas in a very dynamic and innovative environment.

Location and Start Date

In person in Sydney, Australia.

Responsibilities

  • Drive screening and optimization strategy for drug discovery programs to enable the delivery of clinical development candidates following the identification of validated targets and lead structures.
  • Advance drug discovery campaigns to move early exploratory programs through IND readiness and into basic clinical design.
  • Oversee the planning and execution of preclinical assessment, PKPD evaluation, toxicology studies, and other necessary activities to support IND submissions.
  • Monitor project timelines, budgets, and resource allocation to ensure successful and timely IND submissions.
  • Identify and engage clinical CROs to frame a Phase I trial in Australia
  • Lead and mentor a diverse team of experts, including regulatory consultants, the Director of CMC, toxicologists, and GMP consultants.
  • Foster a collaborative and innovative culture to drive excellence in drug development.
  • Proactively identify potential risks and develop risk mitigation strategies to ensure successful IND submissions and progression of drug development programs.
  • Set drug discovery team goals and budgets.
  • Monitor, evaluate, and report project progress to the executive leadership team (CEO, CSO, and others).

Qualifications

  • Ph.D. in Chemistry, Biology, Pharmacology, or related field (or relevant equivalent experience).
  • A minimum of 10 years of pharmaceutical/biotechnology industry experience, with a focus on small molecule drug development and IND-enabling activities.
  • Extensive knowledge of the drug development process and deliverables at each stage of the pipeline, with a focus on IND-enabling studies through clinical proof-of-concept.
  • Strong preference to candidates who have experience in preparing candidates for Australian clinical trials.
  • Proven track record of successfully leading IND submissions and advancing compounds into clinical development.
  • Detail-oriented mindset with exceptional verbal and written communication skills
  • Demonstrated leadership and team management skills, with the ability to inspire and motivate cross-functional teams

Psylo, Inc. is committed to operating a workplace free of discrimination and harassment. We expect every Psylosider to cultivate and maintain our company values of Honesty, Empathy, Accountability, Self-reliance, and Diversity. Through these values, our team maintains a community where everyone has the opportunity to feel included, respected, and encouraged to learn and grow. We provide equal employment opportunities to all qualified candidates and employees, we take responsibility for self-examination of our unconscious bias, and strive for the best inclusionary hiring practices.

Benefits for this role include health, vision and dental insurance and ESOP.

Does this sound interesting, but you are not sure if you are qualified? Interested in engaging with Psylo along these lines as a consultant? We like thinking outside of the box too. With your application, please include a description of how you think your skills would be useful to the team.


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