9 дней назад
Associate Director, Clinical Trial Start-Up (Clinical Research)
164 800 - 247 200$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Clinical Trial Start-Up (Clinical Research): Developing and overseeing global clinical trial start-up strategies, country and site activation plans, and CRO execution with an accent on data-driven planning, regulatory compliance, and operational risk mitigation. Focus on analyzing historical and predictive data, optimizing site activation timelines, and leading cross-functional improvements across clinical research programs.
Location: Remote/Home-Based in California or Philadelphia, Pennsylvania, United States. The role includes 10%–20% travel in the US and internationally.
Salary: $164,800–$247,200 annually for US-based candidates, with potential bonus, equity, and benefits eligibility.
Company
is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.
What you will do
- Lead or oversee study-level clinical trial start-up strategies, country and site activation plans, projections, and risk mitigation.
- Use historical and predictive data, real-world evidence, analytics, and emerging technologies to optimize activation timelines and operational planning.
- Provide subject-matter expertise on global study, country, and site start-up pathways, regulatory requirements, IRB/EC processes, and activation strategies.
- Partner with cross-functional teams to support country and site selection, protocol implementation, timelines, and governance activities.
- Oversee CROs, vendors, and SSU team members, including KPI tracking, training, guidance, and performance feedback.
- Improve SSU policies, SOPs, tools, training, documentation quality, inspection readiness, and process efficiency.
Requirements
- Bachelor’s degree in life sciences or a related field required; an advanced degree is preferred.
- 8–10 years of clinical research experience, including at least 5 years focused on clinical trial start-up or site activation.
- Expertise in global clinical site start-up, regulatory requirements, IRB/EC processes, and site activation pathways.
- Experience leading or supporting global start-up strategies in in-house and outsourced models, including CRO or vendor oversight.
- Strong analytical, strategic thinking, leadership, collaboration, communication, and cross-functional decision-making skills.
- Proficiency with CTMS, document management systems, and SSU technology platforms such as Veeva Vault.
Nice to have
- Experience assessing or using AI in clinical trial start-up.
- Advanced degree in life sciences or a related field.
Culture & Benefits
- Remote/home-based work arrangement with US and international travel.
- Medical, dental, and vision insurance.
- 401(k) retirement savings plan and flexible paid vacation.
- Potential annual cash bonus or incentive compensation and discretionary equity grants.
- Equal opportunity and affirmative action employment practices.
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