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IQVIA · 10 hours ago

Senior Director, MedTech US Clinical Operations

United States

Full-time

Remote

Director/Executive

$235K/yr - $250K/yr

15+ years exp

IQVIA is seeking an experienced clinical operations leader to oversee all U.S.-based MedTech clinical activities. The Senior Director will provide end-to-end oversight of clinical operations regionally within the United States for the MedTech portfolio, ensuring alignment with regulatory requirements and driving efficiency in project management and operations.

AnalyticsHealth CareLife Science

Hiring Manager

Kayleigh Kelly

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

Qualification

Clinical trials managementP&L managementRegulatory complianceProject managementPeople managementFinancial trackingMentoring skillsCollaborationCustomer service skillsIT skillsCommunication skillsProblem-solving skillsPresentation skills

Required

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

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)