Summary:This position provides the leadership and direction to the Global Clinical Operations organization within the Americas Region providing end-to-end site-facing operational capabilities with the key goal of delivering our clinical development programs on time and on budget. The GCO organization functions as the primary connection between our Clinical Development Teams and the 6000 clinical research sites that conduct Janssen clinical trials. They are the face of Johnson and Johnson to the majority of investigators and ensure that the trials are conducted in a GCP-controlled way but with a patient-and site-centric mindset.
The VP GCO Americas is responsible and accountable for Trial Coordination and Site Management activities within the Americas region across USA Canada Brazil Argentina Mexico along with support for numerous non-core countries. This includes but is not limited to oversight leading driving and providing strategic direction to the clinical trial coordination and execution process in conformance to all relevant laws regulations guidelines policies and procedures.
This is accomplished through leading a large and diverse team of 1000 associates (Headcount and Flex) with responsibility for $250M budget. Additionally this individual will establish appropriate connections with appropriate partners to ensure overall portfolio success
e.g. CROs.
As a GCO Leadership Team (LT) member this role is involved in strategic and operational management and decision-making within GCO needs to provide regional input and leadership and lead/support key GD and GCO initiatives or projects.
Principal Responsibilities:
- Drives the needed design input planning and execution for clinical trials in his/her region. This includes the effective protocol feasibility input and site selection and the monitoring of the clinical trial execution including milestone achievements budget and quality.
- Designs the regional organization so that execution of clinical trials by the employees in the region is done according to protocol International Guidelines for Good Clinical Practice international and national SOPs and local procedures and regulations.
- Help shape and communicate the GCO vision through regional leadership and alignment by building an informed aligned and engaged workforce. Ensures alignment of the regional objectives with the overall targets and objectives of the GCO and Global Development.
- Is accountable for the regional annual budget process and prioritizes resource needs. Communicates anticipated projects clinical trial plans and additions to staff. Approves final budget. Oversees workload for the staff to ensure optimal utilization rate of resources throughout the region.
- Creates strong working relationships with critical business partners within and outside GCO and catalyzes his/her organization to do the same. Including Executive liaison with key Regulator bodies such as the Food and Drug Administration as well as interacting with Key Opinion Leaders throughout the Region.
- Accountable for building a high performing team through on-going development performance management and coaching. Takes ownership for ensuring a strong pipeline of leaders within the organization through the Succession Planning process.
- Identifies strategic improvement opportunities and sponsors/leads/contributes to critical improvement projects for GCO.
- Demonstrates a strong track record of leading by example in the areas of Credo Values operating within the boundaries of Health Care Compliance and a mindset of continuous improvement. Report (suspicion of) fraud or scientific/ethical misconduct.
- Leads or participates in cross pharma / cross sector projects. Represents J&J on industry networks.
Principal Relationships:
Internal contacts in the organization: Other Regional GCO Leaders Clinical Trial Management Contracts and Centralized Services (CCS) Delivery Units (DU) Local R&D/Local Operating Company/departments Clinical Supply Chain (CSC) Quality & Compliance Groups R&D Operations Functions External vendor groups Medical Affairs & Commercial Leaders including the Regional Commercial Head.
External contacts outside of the organization: CRO Functional Management Ethics Committees Health Authorities including the F.D.A. and other Regulatory bodies Investigational Sites and others.
Education and Experience Requirements:
- Masters degree (scientific or business orientation) preferred; advanced scientific degree preferred.
- At least 15 years of experience in relevant Clinical Operations / Operations / Commercial functions across career with exposure to clinical development teams/process (from PhI-PhIV through filing)
- Strong knowledge in regulatory and operations compliance and quality control experience
- Proven track record of delivering complex global clinical programs - Strong knowledge in regulatory and operations compliance and quality control experience.
- Experience driving performance through external partnerships specifically in the areas of CROs FSP and Central Labs
- Global and diversity-oriented people management experience includes line management and matrix management. Experience of working in or with truly global and multidisciplinary R&D teams.
- Expert knowledge of clinical operations processes from protocol development to submission across all phases of development (including Medical Affairs). Experience in multiple TAs.
- Foundational knowledge in the areas of Finance and Data Science
- Change management/leadership experience in driving complex transformation efforts.
- Excellent interpersonal and communication skills. Demonstrated ability to influence decision making at all levels. Able to positively impact productivity and business results.
- Ability to develop strong partnerships in a matrix environment.
- Fostering a culture of accountability and empowering others.
- Driving a Credo-based culture including a diverse and inclusive work environment.
- Demonstrated inspirational leadership and ability to set a vision for the future; a drive for delivering and exceeding business results.
- Proven ability to act as a change agent and adapt to rapidly changing organizational and business issues.
Other:
- Travel Percentage: 15-20%
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Budget Management Competitive Landscape Analysis Corporate Management Customer Intelligence Developing Others Forward Thinking Inclusive Leadership Industry Analysis Leadership Operational Excellence Performance Measurement Product Development Lifecycle Qualitative Research Research and Development Stakeholder Management Strategic Change Tactical PlanningThe anticipated base pay range for this position is :
The anticipated base pay for this role in the US is $212000 - $391000.Additional Description for Pay Transparency:
Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:
Job Location:
Monthly Salary:
$ 212000 - 391000
Posted on:
9 hours ago
Vacancies:
1 Vacancy
