Senior Director, Pharmacokinetics

Job Overview

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.

Essential Functions

• 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.

Qualifications

• Ph.D. in Pharmacokinetics Pharmaceutics or related field and 12 years experience including Clinical Pharmacology and line management experience OR Masters 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.

Additional Job Details

• Location: Home-based (Remote)
• Travel: Occasional travel required

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.