At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

QUALIFICATIONS/ REQUIREMENTS:

• Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
• Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.
• Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state.
• At least 4 years of line management experience required. Proficient in decision-making and financial management!
• Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision.
• Proficient in English, with strong computer literacy, interpersonal, and negotiating skills. Demonstrates excellent organizational abilities and the capacity to collaborate effectively while managing multiple priorities within a matrix environment. Consistently performs activities in a timely and accurate manner.

• Providing line management to direct reports, including setting goals and objectives, conducting performance evaluations, and supporting talent development.
• Evaluating and forecasting resource needs for the assigned portfolio and/or other specific areas of responsibility, in collaboration with local GCO management.
• Ensuring the deployment of the One Delivery Model through collaboration and oversight of vendors.
• Being accountable for the acquisition of new talent and the ongoing development of human resources.
• Guiding direct reports in issue resolution and communication with involved stakeholders.
• Leading organizational changes and effectively communicating shifts in priorities as necessary.
• Reviewing and approving expenses in accordance with company policies.
• Demonstrating leadership behaviors aligned with J&J Leadership Imperatives.
• Fostering an environment that encourages sharing of ideas, information, and best practices both internally and externally.
• Providing coaching and mentorship as needed, including conducting accompanied site visits where appropriate.
• Defining, executing, or supporting long-term strategies aligned with GCO, GD, and JJIM R&D strategies to position the local and global GCO organization for success.
• Overseeing the execution and monitoring of clinical trials across all phases (from feasibility to close-out), ensuring inspection readiness within assigned therapeutic area(s) and/or other areas of responsibility.
• Ensuring that relevant operational objectives are met in conformance with established standards.
• Being accountable for appropriate and timely escalation and reporting of issues, including suspicions of fraud, scientific or ethical misconduct, and healthcare compliance breaches. Contributing to CAPA and issue resolution in accordance with required timelines.
• Building and maintaining strong relationships within the local GCO department, Local Operating Company (particularly with Medical Affairs), and other key internal and external stakeholders.
• Developing country capabilities to support effective study placement within the assigned therapeutic area(s) and/or other areas of responsibility.
• Ensuring a robust feasibility process and overseeing site selection to meet country commitments within strategic goals.
• Regularly reviewing operational and quality metrics and driving follow-up actions as appropriate.
• Driving innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/GD overall, fostering a culture of continuous improvement and innovation within the local GCO team.
• Modeling a Credo-based culture within the local GCO team.
• Other duties may be assigned as needed.
  The principal relationships include reporting directly to the Director of Clinical Operations, Director of Operations TA Head, or County Head, and maintaining primary contact with Local Trial Managers (LTMs), Site Managers (SMs), Clinical Trial Assistants (CTAs), the Country Head, other Functional Managers (FMs)/Clinical Research Managers (CRMs), Program Delivery Leaders (PDLs), Trial Delivery Leaders (TDLs), and Strategic Account Leads (SALs) within the country. Additionally, it involves collaborating with R&D and Local Operating Company staff—including Medical Affairs—and coordinating across departments within and outside GCO/GD, such as Delivery Units (DU), Integration and Process Optimization, Integrated Data Analytics & Reporting (IDAR), BRQC, HCC, External Alliances, Contracts & Centralized Services (CCS), and others as required. The role also requires managing external relationships with relevant vendors, health authorities, ethics committees, investigational sites, local vendors, and other external partners to ensure seamless clinical trial operations and adherence to standards.