Associate Director, Clinical Operations

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 is responsible for leading a cross functional or functional Clinical Operations Unit, ensuring execution to clinical operations effectiveness in Regional Clinical Operations United States West region. This position will sit ideally in California (other states in the West will be considered). Travel is anticipated within the region with travel to officein NJ up to 4 times per year.

Key Responsibilities and Major Duties:
  • Direct supervision of line manager(s) within Clinical Operations
  • May supervise and coordinate the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Monitors 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.
  • Anticipates resource needs and provides workload evaluations and task assignments
  • Allocates and assign study resources at the cross functional/functional unit level in alignment with R&D and local research goals and priorities.
  • Supervises clinical trial execution at country level including supervising study metrics and team performance
  • Approves study fee funds and payments based on grant of authority
  • May propose and/or validate country study targets
  • May support Health Authority inspection and pre-inspection activities
  • May 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 tracks and manages performance metrics for Clinical Operations staff
  • Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit
  • May act as a Point of Contact for FSP staff within the country
  • Managing the hiring, performance management and succession planning of staff
  • Performing general and human resource administrative functions
  • Participation in performance calibration and talent review meetings
  • Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GSR, GPV, Market Access, Commercial, Human Resources)
  • May represent RCO in local leadership discussions at the affiliate level
  • Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed
  • Manage partnerships with critical accounts / sites


Supervisory Responsibility:
  • Direct line reporting responsibility for Line Managers & Clinical Trial Monitors


Degree/Certification/Licensure:
  • Bachelors or Master’s Degree within life sciences or equivalent


Experience:
  • 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


Competencies:
  • 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
  • Good verbal and written communication skills (both in English and local language).


Software:
  • Microsoft Suite
  • Clinical Trial Management Systems

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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