1 день назад
Director, Clinical Management Early Phase, CNS (Clinical Research)
186 489 - 278 875$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Director, Clinical Management Early Phase, CNS (Clinical Research): Leading the operational strategy, execution, and completion of early-phase CNS clinical programs with an accent on global clinical development planning, regulatory submissions, vendor governance, and data integrity. Focus on designing clinical development plans, interpreting trial data, preparing health authority documents, managing program-level risks, and coordinating cross-functional teams under GCP, ICH, and company SOP requirements.
Location: Remote within the United States
Salary: $186,489–$278,875 per year, plus incentive opportunity.
Company
is a pharmaceutical company developing and managing clinical programs, including early-phase programs in central nervous system research.
What you will do
- Lead the operational strategy, planning, execution, and completion of global early-phase CNS clinical programs.
- Develop clinical development plans, timelines, budgets, program standards, and financial estimates.
- Coordinate program-level teams, external service providers, cross-functional departments, and alliance governance activities.
- Lead clinical sections of investigator brochures, briefing books, submission dossiers, annual reports, and responses to health authority questions.
- Contribute to clinical trial analysis, interpretation, publications, presentations, HEOR strategy, and data integrity reviews.
- Support inspection readiness, risk mitigation, continuous improvement, and training of Clinical Management personnel.
Requirements
- Bachelor’s degree and at least 14 years of applicable pharmaceutical industry experience, including 10 years of clinical trial management experience.
- Previous supervisory experience and strong people management, communication, planning, analytical, and problem-solving skills.
- Comprehensive knowledge of clinical operations, drug development, SOPs, GCP, and ICH regulations.
- Thorough knowledge of CROs, outsourcing, vendor statements of work, global regulatory requirements, biostatistics, data management, and medical writing.
- Experience with Microsoft Word, Excel, PowerPoint, Outlook, and clinical trial systems such as eCRFs, IRT, and CTMS.
- Ability to travel up to 25%.
Nice to have
- Advanced degree.
Culture & Benefits
- Comprehensive medical, dental, vision, and prescription drug coverage.
- Company-provided life, accidental death and dismemberment, short-term disability, and long-term disability insurance.
- Tuition reimbursement and student loan assistance.
- Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
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