Chief Medical Officer

1 week ago

Australia PharmAbcine Inc. Full time

Job Title: Chief Medical Officer

Reports to: Chief Executive Officer

Company Overview:

PharmAbcine Inc. is a clinical-stage biotechnology company dedicated to developing innovative antibody therapeutics for the treatment of various cancers and other unmet medical needs. With a strong presence in South Korea, the United States, and Australia, the company is committed to advancing its pipeline of next-generation antibody therapeutics.

Job Summary:

The Chief Medical Officer will play a critical role in leading the company's clinical development programs, providing strategic direction, and overseeing the execution of clinical trials. This position requires a seasoned medical professional with expertise in oncology, rare diseases, and clinical research.

Key Responsibilities:

  • Develop and implement clinical strategies to integrate PharmAbcine's compounds into standard oncology and rare disease practices.
  • Manage clinical aspects of regulatory strategies and interactions with health authorities.
  • Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
  • Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders.
  • Provide clinical support and work with the management team to develop and communicate the company's overall corporate strategy.
  • Represent the company and its programs to external audiences, including the investment, medical, and regulatory communities.
  • Lead and supervise the Clinical Research Department, with direct line responsibility for Clinical Operations, Patient Advocacy, Medical Affairs, Clinical CROs, Clinical Consultant, and Biometrics Departments.

Requirements:

  • MD with Board Certification in Medical Oncology or Family/Pediatrics with Oncology training preferred.
  • 10+ years of experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs.
  • Multiple years of management experience leading a clinical group, including clinical/medical affairs and clinical operations.
  • A proven success record in Phase I-IV clinical research studies and trial design, as well as the successful submission of INDs and marketing approval-directed filings (BLAs, NDAs, and MAAs).

Desirable Qualifications:

  • Knowledge of relevant FDA regulations and guidelines, as well as those of the EU and other health authorities.
  • Experience with, or strong knowledge of, oncology drug development, especially biologics or antibody-based.
  • Experience or knowledge of orphan or rare disease drug development.
  • Experience in translational medicine, clinical pharmacology, and early-stage development.
  • Excellent knowledge of the competitive environment for drugs in the Hematology/Oncology marketplace and in research and development pipelines.
  • Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
  • Excellent leadership and interpersonal skills, with the ability to engender credibility and confidence within and outside the company.
  • Must have outstanding executive presence, be science- and data-driven, and have a results-oriented work ethic.
  • Ability to travel domestically and internationally, with a willingness to be productive and successful in an intense work environment.

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