Associate Director, Clinical Operations (Clinical Trial Management & Clinical Trial Associates)

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. The Associate Director Clinical Operations role leads a Clinical Trial Managers and Clinical Trial Associates, ensuring execution to clinical operations effectiveness for phase I-IV clinical studies in Regional Clinical Operations (RCO) Australia and New Zealand. Key Responsibilities and major duties include: Direct supervision of line managers within RCO Supervision and coordination the work assignments and performance of RCO staff inclusive of Clinical Trial Managers (CT Mgrs) and Clinical Trial Associates (CTAs) to ensure timely execution consistent with R&D and local research goals and priorities Effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management. Anticipating resource needs and providing workload evaluations and task assignments Allocation and assignment of study resources at the cross functional/functional unit level in alignment with R&D and local research goals and priorities. Supervision of clinical trial execution at country level including supervising study metrics and team performance Approval of study fee funds and payments based on grant of authority Propose and/or validate country study targets Support Health Authority inspection and pre-inspection activities Support audit preparation & Corrective Action / Preventative Action preparation for local related issues Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met Together with the Head of Clinical Operations track and manage performance metrics for Clinical Operations staff Anticipate and initiate action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit Act as a Point of Contact for FSP staff within the country Managing the hiring, performance management and succession planning of staff Perform general and human resource administrative functions Participate in performance calibration and talent review meetings Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, Regulatory, Pharmacovigilance, Market Access, Commercial, Human Resources) Represent RCO in local leadership discussions at the affiliate level Ensure effective external partnerships with Study Sites, Investigators, Industry Associations, Heath Authorities as needed Manage partnerships with clinical trial sites Qualifications, experience and competencies Bachelor's degree required preferably within life sciences or equivalent A minimum of 10 years pharmaceutical industry experience in Clinical Research or Medical Affairs including extensive experience in people management Prior monitoring experience required • Significant experience in the planning, conduct and management of clinical programs (Phase I-IV) Demonstrated ability to drive project related activities Previous experience leading, managing, coaching and developing direct reports In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs In depth knowledge and understanding of clinical research processes, regulations and methodology Ability to manage and lead complex regional and/or global initiatives Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management Demonstrated organizational and planning skills and independent decision-making ability Strong organization and time management skills and ability to effectively manage multiple competing priorities Outstanding interpersonal, oral and written communication skills to influence, inform or guide others 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 “ Please be aware that BMS Australia is bound by certain global commitments that may affect the appointment of this position.” 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.