Chief Medical Officer

2 weeks ago


Wellington, Wellington, New Zealand Evithé Biotechnology Full time
Chief Medical Officer (CMO)
Pharmaceutical Industry
Full-time

The Biotechnology company is a fast growing bio-pharmaceuticals start-up company that produces novel, patented botanical prescription drugs and multi-target pharmaceutical drugs in the treatment of inflammatory diseases.

The company is based in Wellington, New Zealand and our team works closely with national and international business partners and universities to deliver a high quality prescription drugs that meets international regulatory requirements.

This job fits an all-star that likes a challenge to expand our operations from laboratory research to clinical trials:

The company is expanding their in-house capabilities and this is an opportunity to be an integrative part in the operations of a bio-pharmaceutical company that aims to make a difference in the treatment of inflammatory diseases from Rheumatoid arthritis to sepsis.


  • This job is based in Wellington, New Zealand and requires visits to Australia.
  • Applicants from other cities are required to be in Wellington for 1 week per month.
Responsibilities

  • Lead the clinical development program and the strategic planning.

Including the writing and publication of our Phase 1 clinical trial results and the research and development of our phase 2 clinical trial that will be run across sites in New Zealand and Australia.


  • Collaborate with the team to develop and execute strategic plans, contributing to the long-term success and growth of the company.
  • Develop & execute approved plans using strong project management skills and collaborate both within and outside of the company, meeting project goals without comprising quality, scope, budget and timelines.
  • Support the technical development and planning of in vitro and in vivo research including pharmacokinetic research to assure they meet ICH, TGA and FDA guidelines.
  • Lead the team to implement the required regulations for each segment of the business, identify research and knowledge gaps and source adequate support to complete the regulatory requirements.
  • Lead the development, submission, and approval of data packs to ethics boards, TGA and the Federal Drug Administration (FDA).
  • Liaise with advisors and the FDA to monitor the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted in time.
  • Support the mapping of the value chain and create and maintain the product strategy roadmap.
  • Support the development and ongoing maintenance of Standard Operating Procedures (SOP's).
  • Support the development of strong relationships with strategic partners to support the growth of the company.
  • Ensure consistency, completeness and adherence to standards for all regulatory submissions and support communications with safety monitoring committee.
  • Monitor and interpret regulations to evaluate the impact on the business and advise and develop strategies to leverage any benefit and or mitigate any potential threats.
  • Drive a culture of continuous improvement and operational excellence to enhance productivity, quality, and overall business performance.
  • Support the development of new roles within the company and the implementation of the hiring strategy.
Qualifications & Experience

  • Minimum of a Masters or Ph D in a related field such as biochemistry, immunology, medicine or pharmacology.
  • Medical Monitoring and Quality assurance experience of at least 5 years.
  • Regulatory experience in the pharmaceutical industry or CRO for at least 5 years.
  • ICH, TGA & FDA regulatory pathway experience and familiarity with the application of these regulation requirements in a clinical setting.
  • Ability to support the development of innovation and commercialization pathways within pharmaceutical regulatory frameworks.
  • Experience in pharmaceutical value chain development.
Skills

  • Strong business acumen and strategic mindset, with a proven track record of personally executing strategic plans.
  • Honesty and ability to identify knowledge gaps and address these appropriately.

International market proficiency:
Demonstrable experience and understanding of how to help launch a fast-growing bio-pharmaceutical company into international markets.

  • Strong ability to translate technical information related to equipment, processes, and regulatory expectations.
  • Ability to meet deadlines and support others to do this consistently.
  • The ideal candidate will be a motivated self-starter who can demonstrate a strong ability to work independently, support junior staff and build teams.
  • Exceptional problem-solving skills, with the ability to navigate complex regulatory requirements and drive innovative solutions.
  • Excellent communication and interpersonal skills, with the ability to effectively communicate complex concepts to a diverse audience.
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