Senior Clinical Operations Manager
Karuna Therapeutics
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.
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. Read more: careers.bms.com/working-with-us.
Position Summary
To lead and manage a cross functional Clinical Operations Unit, ensuring delivery of clinical operations effectiveness in RCO-US.
Key Responsibilities
Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial
Monitors (CTMs), Clinical Trial Associates (CTAs), Site Relationship Managers, Study Start-up Specialists and/or Site Contract Leads to ensure timely execution consistent with R&D and local research goals and priorities
Demonstrates the ability to 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 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 RCO management 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
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, GRS, GPV, Market Access, Commercial, Human Resources)
When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager
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
Qualifications & Experience
Bachelors required preferably within life sciences or equivalent
Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs
For CT Monitor Line Managers – 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 supervisory and/or leadership experience (i.e. participation in task force, initiative or cross functional team)
Previous resource allocation experience preferred
Experience mentoring and providing feedback to others
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
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 that must be used independently and without assistance (e.g., Microsoft Suite)
Microsoft Suite
Clinical Trial Management Systems
Working Conditions
Domestic travel to clinical trial sites
International travel where required
Overnight Absences Required (per typical month) ~0-1
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 a supportive culture, promoting global participation 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 an 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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