Associate Director, Clinical Operations Study Lead

BlueRock Therapeutics

Overseeing management and operations of clinical trials at BlueRock Therapeutics. Ensuring compliance with regulatory requirements and fostering collaboration for operational excellence.

Posted 5/28/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $170,000 - $200,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provides strategic and operational leadership for one or more complex clinical studies, ensuring successful delivery through the study lifecycle (planning to execution) ensuring adherence to timelines, budgets, and quality standards.
Develops executable study plans and milestones. Establishes and maintains clinical study timelines.
Utilizes operational data and metrics to drive high-quality planning processes and operational execution. Monitors the same to drive overall performance and risk management.
Maintains a comprehensive overview of study status, proactively communicating progress, risks, and mitigation strategies to stakeholders.
Leads/partners in the development and/or QC review of key study documentation (e.g, study protocols, informed consents, monitoring plans, operational manuals)
Drives operational initiatives key to successful study execution including but not limited to site identification/qualification, site activation strategy, site performance management, overall enrollment success (including mitigation/rescue actions as needed).
Ensures clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines and internal quality standards.
Supports or leads aspects of audit and inspection readiness and risk mitigation initiatives, including root cause analysis and CAPA development/closure for operational findings on assigned studies.
Actively contributes to the advancement of department and organizational initiatives and processes.
Leads study and/or project team(s), including effectively partnering with colleagues from other disciplines. (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators, alliance partners) to ensure seamless trial execution.
Participate in the mentorship of clinical operations staff.
Contributes to the development and implementation of novel clinical operations activities and methods in cell therapy.

Requirements

What you’ll need

Bachelor’s degree in life sciences or related field
7+ years’ experience in clinical operations within the pharmaceutical, biotech and or CRO setting including at least 2 years in a study or team leadership role in a pharma or biotech company.
Experience supporting both early and late-stage clinical studies. Preference for experience with BLA-enabling trials.
Demonstrated success managing complex clinical studies in global settings; strong preference for cell/gene therapy or biologics experience; therapeutic area experience in neurology and/or ophthalmology preferred.
Excellent knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA).
Strong vendor management skills and experience with complex outsourcing and partnership models
Proven financial acumen. Experience managing within a study budget, managing and reporting on change order status
Exceptional verbal and written communication and stakeholder management skills . Track record of developing and delivering high quality materials and updates for leadership forums.
Demonstrated ability to effectively collaborate with internal and external stakeholders in a highly matrixed setting
Ability to thrive in a fast-paced, matrixed, and innovative environment.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account BlueRock Therapeutics Website LinkedIn All Job Openings 201 - 500 employees Founded 2016 🧬 Biotechnology 💊 Pharmaceuticals 🔬 Science 💰 $225M Series A on 2016-12 Biotechnology
Pharmaceuticals
Science BlueRock Therapeutics is a clinical stage cell therapy company dedicated to transforming the treatment of degenerative diseases by developing innovative cell therapy solutions. With a focus on neurology and ophthalmology, BlueRock aims to replace damaged or lost cells to create next-generation medicines with lasting impact. The company is currently working on investigational therapies such as bemdaneprocel for Parkinson’s disease and OpCT-001 for primary photoreceptor diseases, with several clinical trials underway. Associate Director, Clinical Operations Study Lead 🔥 14 minutes ago 🏢🏡 Cambridge – Hybrid 💵 $170k - $200k / year ⏰ Full Time 🟠 Senior 🏥 Clinical Operations 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Provides strategic and operational leadership for one or more complex clinical studies, ensuring successful delivery through the study lifecycle (planning to execution) ensuring adherence to timelines, budgets, and quality standards.
Develops executable study plans and milestones. Establishes and maintains clinical study timelines.
Utilizes operational data and metrics to drive high-quality planning processes and operational execution. Monitors the same to drive overall performance and risk management.
Maintains a comprehensive overview of study status, proactively communicating progress, risks, and mitigation strategies to stakeholders.
Leads/partners in the development and/or QC review of key study documentation (e.g, study protocols, informed consents, monitoring plans, operational manuals)
Drives operational initiatives key to successful study execution including but not limited to site identification/qualification, site activation strategy, site performance management, overall enrollment success (including mitigation/rescue actions as needed).
Ensures clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines and internal quality standards.
Supports or leads aspects of audit and inspection readiness and risk mitigation initiatives, including root cause analysis and CAPA development/closure for operational findings on assigned studies.
Actively contributes to the advancement of department and organizational initiatives and processes.
Leads study and/or project team(s), including effectively partnering with colleagues from other disciplines. (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators, alliance partners) to ensure seamless trial execution.
Participate in the mentorship of clinical operations staff.
Contributes to the development and implementation of novel clinical operations activities and methods in cell therapy. 🎯 Requirements
Bachelor’s degree in life sciences or related field
7+ years’ experience in clinical operations within the pharmaceutical, biotech and or CRO setting including at least 2 years in a study or team leadership role in a pharma or biotech company.
Experience supporting both early and late-stage clinical studies. Preference for experience with BLA-enabling trials.
Demonstrated success managing complex clinical studies in global settings; strong preference for cell/gene therapy or biologics experience; therapeutic area experience in neurology and/or ophthalmology preferred.
Excellent knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA).
Strong vendor management skills and experience with complex outsourcing and partnership models
Proven financial acumen. Experience managing within a study budget, managing and reporting on change order status
Exceptional verbal and written communication and stakeholder management skills . Track record of developing and delivering high quality materials and updates for leadership forums.
Demonstrated ability to effectively collaborate with internal and external stakeholders in a highly matrixed setting
Ability to thrive in a fast-paced, matrixed, and innovative environment. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Manager, Clinical Operations 🕒 May 12 Nuvalent, Inc. 11 - 50 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings Manager of Clinical Operations at Nuvalent responsible for clinical trial planning and execution. Ensuring adherence to regulatory guidelines and managing multiple aspects of clinical studies. 🏢🏡 Cambridge – Hybrid 💵 $125k - $145k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🏥 Clinical Operations Director, Clinical Operations Program Leadership 🕒 March 13 Biogen 5001 - 10000 🧬 Biotechnology ⚕️ Healthcare Insurance 💊 Pharmaceuticals Website LinkedIn All Job Openings Director of Clinical Operations at Biogen overseeing strategy and execution of clinical development programs. Responsible for program delivery and collaboration with multi-functional teams. 🏢🏡 Cambridge – Hybrid 💵 $209k - $288k / year ⏰ Full Time 🟠 Senior 🏥 Clinical Operations 🦅 H1B Visa Sponsor View More Clinical Operations Manager Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

clinical operationsclinical trial designstudy managementrisk managementfinancial acumenvendor managementroot cause analysisCAPA developmentcell therapybiologics

Soft Skills

leadershipcommunicationstakeholder managementcollaborationmentorshipproblem-solvingorganizational skillsadaptabilitystrategic thinkingperformance monitoring