Senior Director, Pharmacokinetics

About the role

The Senior Director, Pharmacokinetics provides strategic, scientific and operational leadership across Clinical Pharmacology PK/PD, Early Clinical Development Biostatistics and Statistical Programming. The role ensures teams are resourced and equipped to meet client and project demands, and oversees the design and execution of early clinical development statistical strategies, including study design, analysis planning, reporting, programming delivery and standards implementation. It is a home-based (remote) position with occasional travel.

Key responsibilities

• Plan, budget and deliver PK/PD, biostatistics and statistical programming activities across projects and portfolios, and act as a senior scientific and operational consultant on complex client engagements.
• Ensure quality, consistency, timeliness and regulatory readiness of statistical, programming and PK/PD deliverables, including analyses, reports, datasets and regulatory submissions.
• Lead resource planning, workforce forecasting, capacity management and project assignments, and oversee study design, statistical methodology, analysis planning, data review, reporting and submission strategy.
• Establish and strengthen quality control, scientific review and operational excellence processes.
• Take part in proposal development, budget planning, bid defenses and client presentations, and partner with Business Development and Project Planning teams.
• Mentor, coach and develop PK/PD scientists, statisticians and programmers, and contribute to SOPs, quality standards and governance.
• Represent Clinical Pharmacology on corporate and cross-functional task forces, and represent early clinical development perspectives in governance and leadership forums.
• Manage staff in line with company policies, including performance management, coaching, succession planning and employee relations.

Required profile

• Ph.D. in Pharmacokinetics, Pharmaceutics or a related field with 12 years of experience including Clinical Pharmacology and line management, or a Master's degree or PharmD with 14 years of experience, or an equivalent combination.
• Proven leadership, coaching and team-building skills, and experience in global matrix organizations.
• Excellent communication, stakeholder management and client engagement skills.

Required skills

• Advanced knowledge of pharmacokinetics, pharmacodynamics, NCA, PopPK modeling and exposure-response analysis.
• Knowledge of the drug development lifecycle, ICH GCP and global regulatory requirements.
• Proficiency with Phoenix WinNonlin, NONMEM, SAS, SigmaPlot and Microsoft Office, as applicable.

The potential base pay range is $137,600 to $383,300 per year, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply.