47 минут назад
Director, Clinical Management (Psychedelics)
186 489 - 278 875$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Clinical Management (Psychedelics) (Clinical Operations/Drug Development): Leading the operational strategy, planning, execution, and completion of global clinical programs with an accent on regulatory compliance, clinical trial quality, and cross-functional program leadership. Focus on developing clinical and regulatory documents, managing CRO partnerships and program risks, interpreting clinical data, and supporting psychedelic programs involving controlled substances.
Location: Remote within the United States; travel of up to 25% may be required.
Salary: $186,489–$278,875 per year, plus an incentive opportunity.
Company
is a pharmaceutical company developing and commercializing medicines and conducting global clinical research.
What you will do
- Lead the operational strategy and objectives of global clinical development programs in collaboration with senior clinical management.
- Plan, execute, and complete clinical programs in accordance with GCP, ICH Guidelines, applicable regulations, SOPs, timelines, and budgets.
- Lead program-level teams, advisory boards, cross-functional meetings, and clinical management representation for assigned programs.
- Develop and maintain clinical and regulatory documents, including investigator brochures, briefing books, submission dossiers, and responses to health authorities.
- Oversee clinical data review, final analysis, clinical trial reports, publications, inspection readiness, and risk mitigation activities.
- Manage CRO and external service provider partnerships, support HEOR strategy, and contribute to portfolio resource planning.
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, organization, planning, analytical, and problem-solving skills.
- Comprehensive knowledge of clinical operations, drug development, SOPs, GCP, ICH regulations, global regulatory requirements, biostatistics, data management, and medical writing.
- Thorough knowledge of CROs, outsourcing, vendor statements of work, and clinical trial implementation and management.
- Strong computer skills, including Microsoft Word, Excel, PowerPoint, and Outlook, plus familiarity with eCRFs, IRT, CTMS, and related clinical trial software.
- Must be able to work remotely within the United States and travel up to 25%.
Nice to have
- Advanced degree.
- Experience with controlled substances.
Culture & Benefits
- 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.
- 401(k) match, flexible time off, paid holidays, and paid leave programs.
- Equal opportunity employment and reasonable accommodation support for qualified applicants.
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