Senior Director, Clinical Compliance and Risk Management

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. This is a fantastic opportunity to impact Clinical Compliance across the Asia Pacific Region in a role that will be based in our head office in Mulgrave with direct reports located in Japan, China, and Australia. You will be experienced in navigating a complex Research and Development Organisation with the ability to engage and develop rapport with regionally located stakeholders. Your leadership and strategic thinking will allow you to build risk mitigation plans with a forward-thinking focus. This is an incredible opportunity to become a leader within our globally acknowledged high performing team. The Senior Director Clinical Compliance & Risk Management will support and enable corporate Global Development Operations (GDO) clinical trial execution & business objectives through support of implementation of the GDO audit management plan, lead regional risk identification/management, preparing and providing local on-site local health authority inspection support assuring GDO is inspection ready at all times. There will be significant partnership with the Global Quality Organisation. · Responsibilities: Collaborate with key stakeholders to develop and implement a process for management of quality issues Engage stakeholders to utilize processes and technologies in support of Quality Management Systems (QMS) processes Embed a sustainable GDO Quality Culture & execute the GDO related QMS Initiate notification and/or escalation of emerging and significant risks to the relevant senior management and governance bodies, as appropriate Identify trends to enhance training and process improvements, assurance that findings from the Accompanied Monitoring Program are tracked and acted upon as part of a wider QMS Oversee vendor activities in relation to monitoring activities in accordance with the Accompanied Monitoring Program Support process improvement activities within QMS Oversight to drive key deliverables as required and ensure timely completion of activities Identify and support the development & implementation of technical training across GDO and within the respective region Assure inspection readiness within the respective region through implementation of the GDO audit management plan, on-site support during site Health Authority inspections and/or local sponsor Health Authority inspections in partnership with BMS global quality organization Coordinate local health authority site inspections or sponsor inspections as necessary Up to 30% Asia Pacific and other international travel may be required Qualifications, experience and competencies: Our ideal candidate will be an experienced Asia Pacific strategic leader with detailed knowledge of clinical compliance & GCP principles and demonstrable strengths in building trust, people engagement and influence A minimum of a Bachelor's Degree (or equivalent degree) is required. Degree in a life science, natural science or business is preferred. At least 8 years of experience in a Good Clinical Practice (GCP) regulated discipline is required. Knowledge of the global drug development process is required. Experience in a GCP quality role is required Experience in and/or knowledge of risk management in a regulated industry is required. In depth technical clinical operations experience/knowledge at site level is preferred Ability to operate in a matrix organization is preferred The candidate will demonstrate the ability to adopt a biopharma enterprise-wide mindset, to act with speed, accountability and integrity, and to have fun along the way To protect the safety of our employees, third parties, customers, patients and communities, BMS Australia requires all employees to be fully up to date (Boostered) with vaccination status using a locally approved vaccination against COVID-19, unless an exemption is applicable under the State or Federal legislation relevant to you (e.g. your state’s anti-discrimination act). Within our policy an exemption can only be approved by the HR Director. By applying for this role, you understand that you will be asked if you can comply with the Policy Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.