7 дней назад
Associate Project Director (Immunology, Rheumatology, Dermatology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Project Director (Immunology, Rheumatology, Dermatology) (Clinical Trials): Leading complex, global clinical trials for biotech, medtech, and specialty pharma clients with an accent on cross-functional coordination, project planning, budgets, and quality management. Focus on managing full-lifecycle studies, resolving delivery risks, maintaining audit-ready documentation, and mentoring project management staff.
Location: United States of America; travel of up to 25% may be required
Company
supports biotech, medtech, and specialty pharmaceutical organizations in developing medicines, medical devices, and diagnostics.
What you will do
- Serve as the primary client liaison and chair project team meetings, aligning study objectives, timelines, milestones, and deliverables.
- Coordinate cross-functional teams across Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety.
- Develop and maintain project plans, manage quality and risk, oversee documentation, and support audits.
- Manage project budgets, scope, forecasting, invoicing, expenses, and change orders.
- Resolve project conflicts, plan resources and transitions, and manage central vendors.
- Support business development, lead proposal presentations, provide training and feedback, and mentor junior project management staff.
Requirements
- Bachelor’s degree or international equivalent, preferably in a clinical, biological, or science-related field.
- 8–14 years of trial management experience in a pharmaceutical, medical device, or CRO environment, including 5–8 years as a Project Leader.
- Advanced project and portfolio-level budget, finance, and costing experience, including coaching and mentoring other project managers.
- Experience managing complex, multi-phase, full-lifecycle global trials and presenting at bid defenses and investigator meetings.
- Expert knowledge of ICH/GCP, project management principles, and the clinical development process, with advanced knowledge of FDA Guidance Documents, EU Directives, and ISO 14155.
- In-depth therapeutic and protocol knowledge in Immunology, Rheumatology, or Dermatology.
Culture & Benefits
- Full-time employment with flexibility and work-life balance.
- Opportunities for professional growth, skills development, and mentoring.
- A collaborative environment where employee ideas and input influence working practices.
- Equal opportunity employment compliant with federal guidelines.
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