4 дня назад
Senior Director, Pharmacokinetics
137 600 - 383 300$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Pharmacokinetics (Clinical Pharmacology/PK/PD): Leading clinical pharmacology PK/PD, early clinical development biostatistics, and statistical programming functions across clinical development programs with an accent on scientific strategy, regulatory readiness, resource planning, and operational excellence. Focus on designing statistical strategies, overseeing complex PK/PD analyses and submissions, advising clients on development plans and regulatory interactions, and developing multidisciplinary teams.
Location: Home-based remote role associated with Durham, North Carolina, United States; occasional travel required.
Annual base pay: $137,600–$383,300.
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Lead Clinical Pharmacology PK/PD, early clinical development biostatistics, and statistical programming functions.
- Oversee study design, analysis planning, reporting, programming delivery, standards implementation, and regulatory submissions.
- Manage resource planning, workforce forecasting, capacity management, budgets, and project assignments across multidisciplinary teams.
- Provide scientific and operational consulting for complex client engagements, development programs, and regulatory strategies.
- Drive quality control, process harmonization, technology and automation initiatives, and operational excellence.
- Develop talent through coaching, mentoring, performance management, succession planning, and career development.
Requirements
- Ph.D. in Pharmacokinetics, Pharmaceutics, or a related field with 12 years of experience, including Clinical Pharmacology and line management; alternatively, a Master's degree or PharmD with 14 years of experience, or an equivalent combination.
- Advanced knowledge of pharmacokinetics and pharmacodynamics, including NCA, PopPK modeling, and exposure-response analysis.
- Knowledge of PK/PD standards, clinical development processes, the drug development lifecycle, ICH GCP, and global regulatory requirements.
- Leadership experience with coaching, mentoring, talent development, team building, and management in global matrix organizations.
- Proficiency with Phoenix WinNonlin, NONMEM, SAS, SigmaPlot, Microsoft Office, and related tools.
- Strong analytical, strategic thinking, communication, influencing, and stakeholder management skills.
Culture & Benefits
- Home-based remote work arrangement with occasional travel.
- Opportunity to lead cross-functional and cross-organizational initiatives within the BIOS organization.
- Health and welfare benefits may be provided in addition to base pay.
- Incentive plans, bonuses, or other compensation may be available depending on the position offered.
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