Note: The job is a remote job and is open to candidates in USA. Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. The Associate Director, Clinical Operations will lead clinical trial operations across the development lifecycle, overseeing study execution, budgets, vendors, quality, compliance, and cross-functional collaboration for assigned Orexin development programs.
Responsibilities
- Lead and oversee end-to-end clinical trial operations from study start-up through close-out for Centessa’s Orexin development programs
- Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies
- Partner closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution
- Contribute to the development and review of key study documents, including protocols, informed consent forms, monitoring plans, EDC specifications, and statistical analysis plans
- Develop, manage, and track clinical trial budgets, ensuring studies are delivered within approved financial parameters
- Provide regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders
- Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance
- Support and facilitate execution of contracts, clinical trial agreements, and study budgets
- Contribute to regulatory strategy and support preparation of submissions to regulatory authorities, including FDA, IRBs, and ECs
- Manage and oversee CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations
- Ensure all clinical operations activities comply with company SOPs, GCP, and ICH guidelines, and support inspection readiness as needed
Skills
- Bachelor's degree in sciences field required
- 8+ years of experience in pharmaceutical, biotechnology, or CRO environments
- Proven experience managing clinical trials across multiple phases (Phase 1–3), including domestic and international studies
- Strong working knowledge of clinical trial operations, global regulatory requirements, ICH guidelines, and GCP
- Solid understanding of clinical development project management, including timelines, resources, budgets, and risk
- Creative and adaptable approach to addressing challenges related to timelines, quality, or budget
- Experience using clinical trial management systems
- Demonstrated ability to oversee vendors, CROs, and external partners
- Demonstrated leadership and ability to influence cross‑functional teams without direct authority
- Strong communication, collaboration, and interpersonal skills
- Highly organized with the ability to manage multiple priorities in a fast‑paced environment
- Proactive problem‑solver with the ability to anticipate needs, take initiative, and implement practical solutions
- Advanced degree preferred
- Experience supporting global clinical trials preferred
- CNS and/or sleep disorder experience preferred
- Prior experience supporting FDA regulatory submissions is a plus
- PMP certification or formal project management training is a plus
Benefits
- Contractors engaged through Centessa are employed through a third-party agency that serves as the employer of record and provides access to a comprehensive benefits package.
- Eligible contractors may enroll in medical plans, including PPO and EPO options, as well as dental and vision coverage after 30 days.
- Additional perks, such as a 401(k), wellness programs, and other discounts, may also be available to eligible contractors.
- Remote role based in the US, with occasional travel.
Company Overview
Company H1B Sponsorship