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Associate Director, Clinical Operations jobs in United States
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Centessa Pharmaceuticals · 1 day ago

Associate Director, Clinical Operations

Centessa Pharmaceuticals is a new kind of pharmaceutical company with a focus on data-driven decision making and an asset-centric R&D model. The Associate Director, Clinical Operations will provide leadership and operational oversight for clinical trials, ensuring that study objectives are met on time and in compliance with regulatory standards.
BiotechnologyPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Clinical trial operationsRegulatory submissionsProject managementCRO managementClinical trial management systemsCNS experienceCommunication skillsCollaboration skillsInterpersonal skillsProblem-solving skills

Required

Bachelor's degree in sciences field required
8+ years of experience in pharmaceutical, biotechnology, or CRO environments in clinical operations
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

Preferred

advanced degree
Experience supporting global clinical trials
CNS and/or sleep disorder experience
Prior experience supporting FDA regulatory submissions
PMP certification or formal project management training

Benefits

Discretionary annual bonus
Participation in our equity program
401(k) plan
Company-sponsored medical, dental, vision, and life insurance
Generous paid time off
Health and wellness program

Company

Centessa Pharmaceuticals

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Centessa Pharmaceuticals is a next-generation biopharmaceutical company that aims to reshape the traditional drug development process.

H1B Sponsorship

Centessa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)

Funding

Current Stage
Public Company
Total Funding
$1.12B
Key Investors
Oberland CapitalGeneral Atlantic,Janus Henderson Investors,Vida Ventures
2025-11-11Post Ipo Equity· $250M
2024-09-11Post Ipo Equity· $225M
2024-04-23Post Ipo Equity· $100M

Leadership Team

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John Crowley
Chief Financial Officer
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Gregory Weinhoff
Chief Business Officer
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Company data provided by crunchbase