Senior Director, Pharmacokinetics

IQVIA•Durham, NC

11d•Remote

About The Position

The Senior Director, Pharmacokinetics provides strategic, scientific, and operational leadership across Clinical Pharmacology PK/PD, Early Clinical Development Biostatistics, and Statistical Programming functions. This role is responsible for ensuring teams are appropriately resourced, equipped with the capabilities needed to meet client and project demands, and positioned to deliver high-quality outcomes across studies and development programs. The position oversees the design and execution of early clinical development statistical strategies, including study design, analysis planning, reporting, programming delivery, standards implementation, and cross-functional collaboration. The Senior Director will establish and execute strategic objectives, drive operational excellence, and lead initiatives that enhance functional performance, innovation, and organizational effectiveness. Key responsibilities include accountability for the planning, budgeting, and delivery of PK/PD, biostatistics, and statistical programming activities across assigned projects and portfolios, ensuring alignment with scope, quality expectations, and timelines. The role also serves as a senior scientific and operational consultant for highly complex client engagements and development programs. Beyond departmental leadership, the Senior Director will contribute to the broader IQVIA BIOS organization by shaping functional strategy, advancing operational improvements, developing talent, promoting innovation, driving standards adoption, and leading cross-organizational initiatives that support long-term business objectives.

Requirements

Ph.D. in Pharmacokinetics, Pharmaceutics, or related field and 12 years experience including Clinical Pharmacology and line management experience OR Master's Degree or PharmD in Pharmacy or related field and 14 years experience OR equivalent combination of education, training and experience required
Advanced knowledge of pharmacokinetics, pharmacodynamics, including NCA, PopPK modeling, exposure-response analysis, and current drug development trends.
Strong understanding of PK/PD standards, methodologies, and operational processes supporting clinical development programs.
Comprehensive knowledge of the drug development lifecycle, ICH GCP, and applicable global regulatory requirements.
Proven leadership capabilities with excellent coaching, mentoring, talent development, and team-building skills.
Strong analytical, strategic thinking, and problem-solving abilities with experience navigating complex scientific and operational challenges.
Proficiency with industry-standard tools and technologies, including Phoenix WinNonlin, NONMEM, SAS, SigmaPlot, Microsoft Office, and related software, as applicable.
Excellent communication, interpersonal, influencing, and stakeholder management skills, with the ability to effectively engage clients, leadership, and cross-functional teams.
Demonstrated ability to lead within global matrix organizations, manage multiple priorities, and collaborate effectively across diverse, multicultural environments.

Responsibilities

Provide strategic, scientific, and operational leadership for Clinical Pharmacology PK/PD, Early Clinical Development Biostatistics, and Statistical Programming, ensuring high-quality, timely, and compliant delivery of project and program objectives.
Oversee the quality, consistency, timeliness, and regulatory readiness of statistical, programming, and PK/PD deliverables, including analyses, reports, tables, listings, figures, datasets, define documentation, regulatory submissions, and decision-support outputs for IQVIA clients.
Lead resource planning, workforce forecasting, capacity management, and project assignments across PK/PD, biostatistics, and statistical programming teams, ensuring optimal alignment of expertise and resources with portfolio and client needs.
Provide strategic oversight of early clinical development statistical and programming activities, including study design consultation, statistical methodology, analysis planning, data review, reporting, interpretation, and submission strategy across clinical development programs.
Establish, implement, and continuously enhance quality control, scientific review, and operational excellence processes to ensure the highest standards of quality, compliance, and efficiency.
Participate in proposal development, budget planning, bid defenses, and client presentations, providing scientific and operational leadership for Clinical Pharmacology PK/PD, biostatistics, and statistical programming components of business opportunities.
Serve as a senior scientific consultant on complex client engagements, clinical development programs, and regulatory strategies, providing guidance on PK/PD methodologies, development plans, study designs, and health authority interactions.
Provide technical leadership, mentoring, coaching, and career development support to PK/PD scientists, statisticians, programmers, and other functional staff, fostering capability growth and organizational excellence.
Contribute to the development, harmonization, and implementation of SOPs, working practices, quality standards, and governance processes across Clinical Pharmacology and the broader BIOS organization.
Act as a Clinical Pharmacology representative on corporate, cross-functional, and cross-organizational task forces, committees, and strategic initiatives.
Partner with Business Development, Project Planning, and operational leadership teams to support business growth, identify new opportunities, and ensure successful project startup and execution.
Serve as a key liaison across Clinical Pharmacology, BIOS, and other functional areas to promote collaboration, consistency, innovation, and operational alignment.
Contribute as a senior leader within the broader IQVIA BIOS organization by shaping functional strategy, driving process harmonization, advancing technology and automation initiatives, developing talent, and representing early clinical development perspectives in governance and leadership forums.
Maintain a comprehensive understanding of advancements in Clinical Pharmacology, PK/PD, biostatistics, and related scientific disciplines through ongoing evaluation of emerging methodologies, technologies, regulatory expectations, and industry best practices, while ensuring team members remain current with evolving trends.
Participate in departmental financial planning and budget management, ensuring responsible stewardship of resources and alignment with organizational objectives.
Manage staff in accordance with company policies and applicable regulations, including workforce planning, performance management, coaching, talent development, succession planning, employee engagement, recognition, corrective action, and resolution of employee relations matters.
May serve as a scientific and strategic consultant in the development of clinical development plans, study designs, PK/PD analyses, global registration dossiers, and regulatory interactions with health authorities worldwide.
Drive innovation and continuous improvement initiatives that enhance scientific rigor, operational efficiency, client experience, and the overall value delivered by Clinical Pharmacology and BIOS teams.
Perform other duties and strategic initiatives as assigned by Clinical Pharmacology leadership.