Chief Medical Officer / Sydney

Chief Medical Officer

• Innovative bio-pharma company
• Sydney HQ
• Competitive remuneration & benefits
• A 'patient first' focused mission
• Work with a like-minded, motivated team

The role

Lead and direct relevant medical responsibilities by providing scientific insight and development of strategy for assigned compounds by participating and leading committees (eg. Product Strategy Teams, Medical-Regulatory-Legal Teams, etc) to realize the companies overall vision.

• Interact internally with senior level management; advise & negotiate to guide the overall activities of the therapeutic area.
• Develop & maintain relationships externally through Advisory Boards, Professional Associations, Professional Meetings & Conferences, etc.
• Manage the budget & provide direction for the therapeutic area budget.
• Medical direction & review for pre & post launch regulatory strategies (which may include label (PI), protocols, Supplemental NDA’s, etc)
• Oversee the medical review & sign off promotional pieces in support of the Medical-Regulatory-Legal committee for products.
• Participate in the publications strategy.
• Collaboration & input to New Business Development opportunities.
• Conduct regular review of training effectiveness.
• Other medical and scientific support duties as assigned

You

• A positive 'can do' attitude.
• MD degree.
• 5+ years of relevant clinical practice, research, academic and/or pharmaceutical industry experience.
• Experience with clinical research, publication activities, congress presentations, and public speaking.
• Life cycle management experience.
• Preferably experience in cGMP working environment, start-ups, commissioning and qualification of process equipment in an operating plant.
• An understanding and experience of quality systems and the need to develop and follow SOPs, particularly in a cGMP environment.
• Understand pharmaceutical industry regulations governing medical functions within industry activities & medical regulatory processes.