Director, Clinical Operations

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $186k - $279k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Generate Biomedicines

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

📋 Description

• Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies and related development activities • Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives • Own study timelines, budgets, resource allocation, quality metrics, and overall delivery • Lead scenario planning, risk forecasting, and mitigation strategies at the program level • Partner with Clinical Development leadership on portfolio-level planning and decision-making • Directly manage and develop Clinical Operations staff • Recruit, hire, onboard, and retain talent • Set performance expectations, conduct evaluations, provide coaching, and support career development • Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC • Coordinate internal stakeholders, CRO partners, and external vendors • Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives • Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs • Oversee study budgets, vendor performance, and quality metrics • Establish performance metrics and drive continuous improvement across external partnerships • Lead inspection readiness strategy and support regulatory inspections • Drive issue identification, risk management, and CAPA oversight • Contribute to Clinical Operations strategy, infrastructure development, and process optimization • Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies • Share best practices and define standards across the clinical operations organization

🎯 Requirements

• 12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry • Bachelor’s degree required • Significant experience leading global late-phase (Phase 3) studies • Demonstrated success in direct people management, including hiring, performance management, and team development • Proven ability to lead complex cross-functional teams and influence at senior leadership levels • Strong expertise in CRO oversight, global regulatory environments, and inspection readiness • Strategic thinking and strong operational execution skills • Deep working knowledge of ICH/GCP and global clinical development regulations

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package