Senior Director, MedTech US Clinical Operations Lead

IQVIA•Washington, DC

11h

About The Position

Job Overview IQVIA MedTech is seeking an experienced clinical operations leader to oversee all U.S.-based MedTech clinical activities. The Senior Director, MedTech US Clinical Operations will provide end-to-end oversight of clinical operations regionally within the United States for the MedTech portfolio, ensuring alignment with regulatory requirements, quality standards, and business objectives. This role will serve as the primary point of accountability for U.S. clinical execution across project management, monitoring, start-up and administrative functions; driving efficiency, risk mitigation, and operational scalability. Essential Functions Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work appraising performance and guiding professional development rewarding and disciplining employees addressing employee relations issues and resolving problems. Approve actions on human resources matters. Provide strategic oversight of the regional P&L, ensuring financial targets are met through effective resource allocation, cost management, and revenue optimization. Work with individual staff to make sure all study management and project deliverables are completed as per the contract, to achieve quality deliverables on time and within budget and in accordance with SOPs, policies and practices. As their first point of contact, provide effective and timely consultation/guidance to employees on issue resolution. Coach and mentor employees around project planning, project review, risk management and problem solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees. Obtain and provide regular feedback to employees from other project team members and key stakeholders to assist in personal and professional development. May attend project team meeting in order to support development needs. Identify skill and competency gaps at the individual level and work to craft development plans that will close the gaps. Ensure direct reports demonstrate working knowledge of EAC, baseline and change control in terms of scope, budget, schedule and risk/ issue management. Train the Project Lead management team on process and procedures. Ensure required trainings are completed on time. Complete and discuss the Project Lead competency framework with each direct report. Actively engaged with the review of project performance dashboard for tracked information. Follow up with direct reports to ensure system and metrics compliance. Review metrics and ensure required updates are made in IQVIA systems to ensure accurate and timely reporting is available to senior management. Proactively manage risks linked to resourcing, project and/or individual needs with other management and leadership team members to manage study issues and obstacles. Work with individual staff to identify any quality issues within the study and provide coaching on resolution of issues, including implementation of corrective and preventative action plans and escalation. Provide technical expertise and/or clinical project management experience to assigned staff for training and process improvement efforts. Lead and/or actively participate in corporate initiatives Act as a departmental cross-functional liaison and/or change agent Provide technical expertise and project management experience. Provide consultation to clients on medical device development process, strategy, and plans as needed. Act as a Project Management liaison with other groups within IQVIA.

Requirements

Bachelor's Degree Life Sciences or related field
Demonstrated experience in full ownership and management of a regional Profit & Loss (P&L), including budgeting, forecasting, and financial performance accountability.
Experience with leading medical device clinical trials is highly preferred
Requires broad management knowledge to lead cross-regional teams, and well as the ability to influence others outside of own job area regarding policies, procedures, and goals.
Requires 15 years of clinical research experience including 9 years of leadership experience.
Equivalent combination of education, training and experience.
Knowledge of clinical trials - In depth and skill in applying applicable clinical research regulatory requirements i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Strong understanding of the Clinical Research industry and the relevant environments in which it operates.
People Management - Proven ability to manage a team and work through others in a global environment to deliver results to the appropriate quality and timeline metrics.
Provides others with a clear direction delegates work appropriately and fairly, motivates and empowers others, monitors/manages performance and provides feedback and coaching; recruits, develops and retains staff of a high caliber
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
Effective team-management skills.
Collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences, as well as establishing and maintaining effective working relationships with coworkers, managers and clients.
Leadership - Ability to manage competing priorities.
Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal stakeholders and customers as well as negotiate solutions.
Strong ability to balance operational and strategic priorities.
Knowledge of financial tracking and accounting methods and skill in applying them.
Excellent judgment and decision-making skills.
Organization - Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
Excellent organization and problems-solving skills.
Strong presentation skills.
Strong understanding of other IQVIA functions.
Communication - Excellent communication and interpersonal skills, including good command of English language.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Results Oriented - Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
IT Skills - Strong software and computer skills, including MS Office applications.
IQVIA Core Competencies - Strong ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation, Ownership).

Responsibilities

Manage staff in accordance with organization’s policies and applicable regulations.
Responsibilities include planning, assigning, and directing work appraising performance and guiding professional development rewarding and disciplining employees addressing employee relations issues and resolving problems.
Approve actions on human resources matters.
Provide strategic oversight of the regional P&L, ensuring financial targets are met through effective resource allocation, cost management, and revenue optimization.
Work with individual staff to make sure all study management and project deliverables are completed as per the contract, to achieve quality deliverables on time and within budget and in accordance with SOPs, policies and practices.
As their first point of contact, provide effective and timely consultation/guidance to employees on issue resolution.
Coach and mentor employees around project planning, project review, risk management and problem solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees.
Obtain and provide regular feedback to employees from other project team members and key stakeholders to assist in personal and professional development.
May attend project team meeting in order to support development needs.
Identify skill and competency gaps at the individual level and work to craft development plans that will close the gaps.
Ensure direct reports demonstrate working knowledge of EAC, baseline and change control in terms of scope, budget, schedule and risk/ issue management.
Train the Project Lead management team on process and procedures.
Ensure required trainings are completed on time.
Complete and discuss the Project Lead competency framework with each direct report.
Actively engaged with the review of project performance dashboard for tracked information.
Follow up with direct reports to ensure system and metrics compliance.
Review metrics and ensure required updates are made in IQVIA systems to ensure accurate and timely reporting is available to senior management.
Proactively manage risks linked to resourcing, project and/or individual needs with other management and leadership team members to manage study issues and obstacles.
Work with individual staff to identify any quality issues within the study and provide coaching on resolution of issues, including implementation of corrective and preventative action plans and escalation.
Provide technical expertise and/or clinical project management experience to assigned staff for training and process improvement efforts.
Lead and/or actively participate in corporate initiatives
Act as a departmental cross-functional liaison and/or change agent
Provide technical expertise and project management experience.
Provide consultation to clients on medical device development process, strategy, and plans as needed.
Act as a Project Management liaison with other groups within IQVIA.