Service Medical Director leading Anaesthesia and Perioperative Medicine at Monash Health. Collaborating across departments to ensure effective healthcare delivery and patient safety standards.
About the role
- Is accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials
- Applies technical and clinical/medical skills to ensure the design of efficient and high-quality clinical trials
- Responsible for effective execution of studies and works in close partnership with clinical/team colleagues
- Accountable for timely delivery of a quality protocol and clinical execution of clinical trials
- Maintains compliance with internal and external standards
- Performs medical monitoring of clinical trials
- Acts as the primary contact with external investigators and internal study teams for clinical/medical questions
- Provides input to the development of protocol design and oversees development of protocol amendments
- Ensures TMF compliance for clinical documents
- Supports disclosure of safety and efficacy data and trial conclusions
Requirements
- Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university
- Minimum of 4-years Clinical Development experience in industry/CRO
- Licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years post their intern/house officer/foundation period
- Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority
- Clinical research experience in phase 3/pivotal space
- Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
- Demonstrated clinical/medical, administrative, and project management capabilities
- Excellent verbal and written communication skills in English
- Demonstrated experience establishing, managing, and training teams in clinical development
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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