Director, Head Of Clinical Operations, Latam North (Colombia And Mexico)

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Job Summary: This role will be part of the Regional Clinical Operations (RCO), Latam North, R&D regional organization, and will be responsible for the execution of phase I-IV clinical studies in Colombia and Mexico.
Job Description: This role will lead the Latam North Cluster clinical operations teams and is responsible for execution excellence in operational planning, implementation, trial management, site management and monitoring of clinical trials (registrational, non-registrational / Investigator Sponsored Research (ISR)) conducted within Colombia and Mexico.
This leadership role will serve as a member of the RCO LATAM Senior Leadership Team and be part of the RCO and GDO extended leadership teams.
This role will also serve as a member of the local affiliate leadership team (as applicable) managed by the General Managers of the Countries, as well as other affiliate senior leadership committees.
This role will interact with the development teams, local medical and key BMS stakeholders in order to ensure effective management of Latam North conducted clinical trials.
This role will support a GDO Quality culture collaborating with both the GDO Global Clinical Compliance team as well as the GQ Clinical Trial and Safety group.
Job Responsibilities: Executes clinical trials, as per the Colombia and Mexico Book of Work.
Ensures timely study start-up and that target subject recruitment numbers and database lock timelines are met.
Proactively evaluates clinical trial feasibility and site selection by collaborating with the BI&A and Medical country teams to evaluate current metrics and data.
Endorses country and site feasibility targets for Colombia and Mexico.
Manages the Mexico and Colombia team's workload and support of multiple studies.
Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities.
Takes a broad business perspective when making decisions.
Makes judgements to ensure work is achieved within target timelines.
Exercises sound judgement in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities.
Builds and maintains a highly performing team of highly qualified, Mexico and Colombia based, research professionals and the respective line managers.
Managing the hiring, development, coaching, mentoring, performance management and succession planning of staff.
Ensures effective utilization of FSP resources in the execution of clinical trials conducted in the Latam North Cluster.
Meeting or exceeding project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing.
Develop, maintain and maximize strong working relationships with peers, senior leaders, key stakeholders and external institutions/networks to influence decisions and achieve optimal results focused on our patients.
Drive alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders.
Identify, maintain and optimally grow clinical investigative site/Institution/Network relationships through direct/personal and/or group engagements in most impactful manner.
Supports a GDO Quality Culture.
Ensures a continuous improvement mindset across the group.
Supervisory Responsibility for line management of Clinical Trial Managers, Clinical Trial Monitors, Clinical Trial Associates, Study Start-up and Site Contract Lead, Trial Managers - Late Development and Trial Specialists - Late Development role.
Required Qualifications: Bachelors degree required preferably within life sciences or equivalent.
Minimum of 10 years of experience in people and project management in a pharma/biotech/CRO organization.
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.
Understands the drug development process, from early to late stage, including lifecycle management.
Deep knowledge of clinical trial operations including monitoring methodologies, systems, regulations/compliance, budget and resource management and site facing engagements.
Knowledge of the external country clinical trial environment and stakeholders therein, both for Mexico and Colombia.
Demonstrated organizational and planning skills and independent decision-making ability.
Highly organized and motivated possessing excellent communication, interpersonal and presentation skills.
Passionate, accountable and innovative critical thinker who balances risk/speed for maximum results.
Outstanding interpersonal, oral and written communication skills to influence, inform or guide others.
Results oriented with proven track record in building strong, collaborative relationships with internal and external stakeholders to manage the Latam North book of work.
Good verbal and written communication skills (both in English and Spanish).
Preferred Qualifications: Experience working with Public Institutions /Systems, both in Mexico and Colombia.
Experience in participating /leading interactions with Regulators, Trade Associations and Clinical Trial Associations both in Colombia and Mexico.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol: BMS has a diverse occupancy structure that determines where an employee is required to conduct their work.
This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.
The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility.
Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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