2 дня назад
Director, Clinical Science
201 840 - 302 760$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Clinical Science (Clinical Research): Leading clinical development plans, study designs, protocols, clinical trial execution, and regulatory submissions with an accent on late-phase studies, biomarker and pharmacokinetic strategy, and cross-functional scientific leadership. Focus on overseeing pivotal trials, reviewing emerging clinical data, managing study risks and deliverables, and guiding interactions with regulatory agencies, CROs, and external experts.
Location: Basking Ridge, New Jersey, United States
Salary: $201,840–$302,760 per year
Company
is a global pharmaceutical company developing innovative therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
What you will do
- Lead development plans, study designs, protocols, informed consent forms, and clinical sections of regulatory documents.
- Oversee large, late-phase and potentially pivotal clinical trials, including recruitment, retention, compliance, risk management, and contingency planning.
- Direct biomarker, pharmacokinetic/pharmacodynamic, data review, statistical analysis, and data quality strategies with cross-functional teams.
- Review emerging clinical data, lead dose-escalation meetings, and ensure timely delivery of clinical milestones and outputs.
- Represent Clinical Science in integrated and operational project teams and serve as a subject matter expert for Clinical Operations, CROs, AROs, and vendors.
- Lead regulatory and external interactions with health authorities, IRBs, key opinion leaders, advisory boards, and internal experts.
Requirements
- Bachelor's degree in life sciences or a related field.
- 10+ years of relevant clinical experience.
- Experience leading large, late-phase clinical studies, including Phase 2/3 or Phase 3 trials.
- Advanced expertise in preclinical and clinical research, protocol writing, data review, study design, and clinical trial strategy.
- Ability to travel up to 20% of the time.
Nice to have
- Master's degree, PharmD, PhD, or equivalent qualification.
- Postgraduate training in a therapeutic area or related specialty.
- Hematology experience.
Culture & Benefits
- Work within a global pharmaceutical organization focused on innovative medicines and unmet medical needs.
- Collaborate with scientific, clinical, regulatory, commercial, and external stakeholders.
- Participate in program strategy, in-licensing, acquisition due diligence, and performance-based team development.
- Full-time professional employment with a benefits program.
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