Justyn Cleary-Byrne Email & Phone Number

Sydney, Nsw, Au

Sydney, Nsw, Au

Sydney, New South Wales, Australia

I am responsible for providing Pharmaceutical, Biotechnology, and Medical Device tailored Research and Development Clinical Operations [scope of activities include the following (but not limited to): Field insights gathering (to support clinical research activities, protocol and Investigator Brochure design and development); KOL Mapping and Publication Review; Line Management; Global Project Management (PM), Local PM, Country/ Start-up Specialist) assuring compliance with ICH-GCP and other regulatory standards, that result in accelerated product development while optimising expenditure and streamlining processes. My clinical strategy consultancy spearheads the planning, implementation and evaluation of clinical and operational initiatives in line with the Sponsor organisation’s strategy, ensuring safe, effective, and resource-efficient service delivery.My consultancy offerings also include: Optimising Medical Affairs/Medical Strategy, Medical Science Liaison, KOL Engagement, Business Development, Relationship Management, Territory Management, Change Management Strategy and Leadership (Departmental Head and Line Management). I have proven leadership in strategic planning initiatives at an executive level, optimising healthcare resource allocation and enhanced patient-centred service delivery within multiple teams. I have managed significant operating budgets with regular reporting to executive leadership, optimising resource use while ensuring alignment with approved budgets and strategic objectives.Expertise in Early Phase I - IV Clinical Trials across multiple Therapeutic Areas including (but not limited to): Oncology (Immuno-oncology), Immunology (Rheumatology, Autoimmune and Inflammatory disease), Ophthalmology, Dermatology, Vaccines, Paediatrics, Gastroenterology, Endocrinology and Women’s Health.

Sydney, New South Wales, Australia

I was responsible for Corporate Business Development in the Australian and New Zealand markets, leading strategic initiatives by identifying, evaluating, and executing external opportunities in the Pharmaceutical, Biotechnology, and Medical Device Industries, driving revenue growth, managing budgets, providing long-term strategic leadership, and optimising cross-functional matrix relationships. Drove continuous improvement initiatives to drive increase business prospects; establish professional development programs that enhanced team capabilities to meet evolving healthcare demands and strategic objectives.

Australia

I was responsible for the provision of medical and scientific expertise to support the corporate medical and commercial business strategies; Built and strengthened relationships with Key Thought Leaders, Healthcare Professionals and Industry groups, fostering collaborations that supported mutual objectives and enhanced patient centric outcomes. Develop and deliver medical information and education to Healthcare Professionals (HCP) and internal/external stakeholders; Regularly perform landscape and treatment gap analyses to monitor competitive intelligence that contribute to medical/commercial/market access strategies; Collaborate with marketing and sales teams to develop and review promotional materials; Ensure compliance with medical and regulatory standards (MA -Code of Conduct); Participate in the development and execution of medical strategies and plans in the Immunology therapeutic area; Review of Publication/Scientific literature; Represent company at medical conferences; Lead advisory boards, steering committees and other scientific events with engaged HCPs; Support clinical research activities (including the design and conduct of studies and data analysis); Review and provide input on clinical trial protocols, Investigator Brochures and regulatory submissions; and maintain clinical expertise in a role dedicated to Medical Science Liaison responsibilities, specifically in Adalimumab (Immunology, Autoimmune and Inflammatory Diseases – Rheumatology and Gastroenterology) and Rituximab (Haematology Oncology) biosimilars.

Sydney, Australia

I was responsible for the provision of medical and scientific expertise to support the medical and commercial business strategies; develop and deliver medical information and education to Healthcare Professionals (HCP) and internal/external stakeholders; Engage with Key Opinion Leaders and HCPs to gather insights and build relationships; regularly perform landscape and treatment gap analyses to monitor competitive intelligence to contribute to medical/commercial/market access strategies; Collaborate with marketing and sales teams to develop and review promotional materials; Ensure compliance with medical and regulatory standards (MA -Code of Conduct); Participate in the development and execution of medical strategies and plans in the Bone and Cardiology therapeutic area; Review of Publication/scientific literature; Represent company at medical conferences; Lead advisory boards, steering committees and other scientific events; Support clinical research activities (including the design and conduct of studies and data analysis); Review and provide input on clinical trial protocols, Investigator Brochures and regulatory submissions; Maintain clinical expertise in a role dedicated to Medical Science Liaison responsibilities, specifically in Bone and Cardiology.

Sydney, Australia

Responsible for achieving monthly, quarterly, and annual sales targets through effective and compliant territory planning, while building and maintaining customer relationships, fostering collaboration across teams, supporting change management, driving innovation, and ensuring full accountability for compliance with all relevant laws, regulations, and policies.

Dee Why, New South Wales, Australia

Responsible for the leadership, strategic planning, and operational delivery for assigned clinical studies, ensuring compliance with quality standards, regulations, ICH-GCP, SOPs, timelines, and budget commitments, while fostering optimal site relationships and actively participating in overall therapeutic leads and country expert activities within a cross-functional context.

Sydney, New South Wales, Australia

Responsible for the end-to-end execution and delivery of clinical studies, ensuring adherence to quality standards, timelines, resourcing, and budget, while providing leadership, strategic direction, and oversight to Clinical Management teams, and ensuring reporting alignment with local/regional KPIs to Country Head and Regional Operations Head.

Master Of Commerce Law, Commerce Law

Bachelor'S Degree, Registered Nursing/Registered Nurse

Bachelor'S Degree, Registered Nursing/Registered Nurse, 5.0

Bachelor Of Science - Bs, Registered Nursing/Registered Nurse

Medicines Australia Code Of Conduct

Education record

Medicines Australia - Code Of Conduct

Education record