9 дней назад
Senior Director of Clinical Operations
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director of Clinical Operations (Clinical Trials/Biotech): Owning clinical and regulatory delivery for a Phase 2 trial from start-up through close-out, with an accent on safety, quality, risk-based oversight, and on-time, on-budget execution. Focus on making real-time clinical decisions, shaping portfolio-wide SOPs and trial systems, signing off essential trial documents, and guiding complex FDA-facing operations.
Location: Remote in the US
Company
Developing clinical-stage therapeutic assets through integrated, technology-first clinical trial infrastructure, with a focus on improving biopharma development.
What you will do
- Own clinical and regulatory delivery for one in-licensed asset from trial start-up through close-out.
- Ensure trial quality, safety, timeline, and budget performance while working closely with the Clinical Program Manager.
- Identify and mitigate risks and contribute to the asset’s clinical development plan.
- Shape Clinical Operations SOPs, processes, monitoring standards, oversight practices, and quality systems across the portfolio.
- Advise on clinical delivery requirements for Citrus and other trial systems in partnership with Product and technology teams.
- Provide portfolio-wide sign-off on safety, trial design, proportionality, essential documentation, and quality issues while mentoring the ClinOps team.
Requirements
- 15+ years of clinical operations experience with hands-on delivery across multiple Phase 2 drug trials.
- Experience with complex neurology trials in chronic indications, ideally Parkinson’s disease.
- First-hand experience making clinical, quality, and safety decisions across multiple trials.
- Senior review and sign-off experience for monitoring plans, RAMPs, protocol deviations, and eTMF readiness.
- Experience designing SOPs and processes at portfolio or function level and influencing EDC, CTMS, and eTMF systems.
- Experience across multiple regulatory jurisdictions; FDA experience is preferred.
Nice to have
- Experience with FDA-facing clinical trials.
- Experience in Parkinson’s disease trials.
Culture & Benefits
- Mission-driven, high-growth, VC-funded startup environment.
- Competitive salary and meaningful stock options.
- 27 days of annual leave plus 11 national holidays.
- US health insurance through TriNet, enhanced parental leave, and a monthly wellness allowance.
- $2,000 annual learning and development allowance.
- Remote team lunches, virtual and in-person company events, and access to gym and retail discounts.
Hiring process
- Initial 30-minute conversation with a Senior Talent Partner.
- Second interview with the VP Operations and another interviewer, followed by a functional interview with the CMO and Head of Quality.
- Final 30-minute values interview with two team members.
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