Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Position Summary
The Associate Director, Regional Clinical Operations (RCO) is a senior leadership role within the RCO organization providing functional, strategic or country level leadership. The Associate Director has a pivotal role in:
shaping the external environment through interactions with industry fora and external stakeholdersstrategic decisions around which clinical trials should be run in the UK and Irelandensuring performance on our book of workfunctional leadership of the Clinical Trial Managers (project managers) in regional clinical operationsKey Responsibilities
Provides functional, strategic or country leadershipSupervises and coordinates work assignments and performance of RCO staff inclusive of Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs), Country Coordinators (CCs), Site Contract Leads (SCLs) and/ or Trial Managers – Late Development (TM-LD) and Trial Specialists – Late Development (TS-LD) to ensure timely execution consistent with R&D and local research goals and prioritiesEffectively communicates with and influences individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis managementAnticipates resource needs and provides workload evaluations and task assignmentsAllocates and assigns 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 performanceApproves study fee funds and payments based on grant of authority and may approve site contractsProposes and/or validates country study targetsSupports Health Authority inspection and re-inspection activitiesSupports audit readiness activities, and the development and implementation of Corrective and Preventative Actions (CAPAs) for identified issues, also ensuring the necessary resources / tools are availableDevelops goals aligned with R&D and local research goals and priorities and takes necessary actions to ensure that goals are metManages performance metrics for Clinical Operations staffAnticipates and initiates action in response to multiple/changing demands and project priorities placed on RCO organization and teamActs as a Point of Contact for FSP staff within the countryManages the hiring, performance management and succession planning of staffPerforms general and human resource administrative functionsParticipates in performance calibration and talent review meetingsEnsures collaboration and information sharing with local country cross functional stakeholders (Medical, GSR, GPV, Market Access, Commercial, Human Resources)Represents RCO in local leadership discussions at the Affiliate levelEnsures effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath AuthoritiesManages or supports partnerships with critical accounts / sites
Supervisory Responsibilities
Direct line reporting responsibility of CTMs, CRAs, CCs, SCLs, TM-LDs and/or TS-LD roles
Key Stakeholders/Contacts
Stakeholders within RCO, Global Development Operations (GDO) & Global Drug Development organization and within the local affiliate organization including, Medical, Regulatory, Pharmacovigilance, Market Access, Commercial, Human Resources, Legal, local clinical trial sites, Industry bodies, etc
Qualifications, Competencies & Experience
Bachelor’s degree required, preferably within life sciences or equivalent
10 years’ experience in pharmaceutical or relevant industry, including extensive experience in people managementPrevious experience leading, managing, coaching and developing people and teamsDeep understanding of Clinical ResearchDemonstrated experience in the planning, conduct and management of clinical programs (Phase I-IV)Demonstrated ability to drive project related activities
In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical AffairsIn depth knowledge and understanding of clinical research processes, regulations and methodologyAbility to manage and lead complex regional and/or global initiativesUnderstands clinical landscape with practical knowledge of a variety of medical settings and medical records managementDemonstrated organizational and planning skills and independent decision-making abilityStrong organizational and time management skills and ability to effectively manage multiple competing prioritiesOutstanding interpersonal, oral and written communication skills to influence, inform or guide others
Microsoft SuiteClinical Trial Management System (CTMS)