Associate Director, Clinical Operations Lead -Asthma jobs in United States
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Generate:Biomedicines · 2 weeks ago

Associate Director, Clinical Operations Lead -Asthma

positionUnited States
timeFull-time
remoteRemote
seniorityLead/Staff, Director/Executive
money$162K/yr - $210K/yr
date8+ years exp

Generate:Biomedicines is a pioneering therapeutics company at the intersection of machine learning, biological engineering, and medicine. They are seeking an Associate Director, Clinical Operations Lead to oversee global Phase 3 asthma studies, ensuring successful planning, execution, and delivery of study objectives while collaborating with cross-functional teams and CRO partners.

Artificial Intelligence (AI)BiotechnologyHealth CareMedicalProduct Research
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H1B Sponsor Likelynote
Hiring Manager
Rayelle Theeck SHRM-SCP
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Responsibilities

Serve as the operational lead for global Phase 3 asthma studies, ensuring successful planning, execution, and delivery of study objectives
Develop overall study strategy, timelines, and operational plans aligned with program goals and regulatory expectations
Lead scenario planning, risk assessment, and proactive mitigation efforts to maintain quality and timelines
Review and approve key trial documents, including protocols, amendments, plans, and manuals
Lead and coordinate multidisciplinary study teams (clinical operations, data management, biostatistics, safety, regulatory, medical, quality)
Act as the central point of accountability across internal stakeholders, CRO partners, and external vendors
Enable effective communication, decision-making, and timely issue escalation across the study team
Oversee study start-up, site identification, enrollment strategy, monitoring plans, and patient engagement initiatives
Ensure study conduct follows ICH-GCP, SOPs, and global regulatory requirements
Manage study budget, vendor performance, timelines, and operational quality metrics
Identify and manage trial risks, as well as oversee maintenance of issue, action and decision logs
Assist in audit preparation and ensure corrective and preventive actions (CAPAs) are implemented
Partner closely with data management and biostatistics to ensure data quality, timely database lock, and high-quality deliverables
Drive inspection readiness and continuous study health assessments
Ensure accuracy and completeness of submission-supporting documents, reports, and responses
Provide operational oversight of CROs and other third-party vendors, ensuring performance and deliverables meet expectations
Contribute to vendor selection, scope development, contracting, and ongoing governance
Provide mentorship and operational guidance to junior team members and cross-functional partners
Share best practices and champion process improvements across the clinical operations function

Qualification

Clinical operations experienceLate Phase studiesRegulatory interactionsStrategic planningPharmaceutical industry experienceLeadership skillsDigital trial toolsPatient engagement modelsCommunication skillsProblem-solving skillsCross-functional collaborationMentorship

Required

8–12+ years of clinical operations experience with at least 6 years of direct leadership in leading cross functional teams in Late Phase global studies
Late Phase Respiratory or immunology therapeutic area experience
Demonstrated expertise in late-phase study execution, regulatory interactions, and oversight of CROs and vendors
Strong leadership, strategic planning, communication, and problem-solving skills
Ability to work independently while orchestrating complex cross-functional execution
Pharmaceutical industry experience and working knowledge of ICH/GCP regulations
Bachelor's degree required

Preferred

Advanced degree (MS, MPH, PharmD, PhD) preferred
Experience in high-growth or early-build clinical development organizations
Familiarity with digital trial tools, decentralized approaches, or innovative patient-engagement models

Benefits

Annual bonus
Equity compensation
Competitive benefits package

Company

Generate:Biomedicines

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Pioneering generative biology to create breakthrough therapeutics.
dateFounded in 2018
location
Somerville, Massachusetts, USA
people-size201-500 employees
web-link
https://generatebiomedicines.com

H1B Sponsorship

Generate:Biomedicines 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 (7)
2024 (12)
2023 (9)
2022 (3)
2021 (2)
2020 (1)

Funding

Current Stage
Growth Stage
Total Funding
$693M
Key Investors
Samsung Life Science FundAlumni VenturesFlagship Pioneering
2024-12-18Series Unknown
2023-09-14Series C· $273M
2021-11-18Series B· $370M

Leadership Team

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Gevorg Grigoryan
Founding CTO
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Recent News

Morningstar.com
Generate:Biomedicines to Initiate Global Phase 3 Studies of GB-0895, a Long-Acting Anti-TSLP Antibody for Severe Asthma Engineered with AI
2025-12-01
Canada NewsWire
Generate:Biomedicines to Initiate Global Phase 3 Studies of GB-0895, a Long-Acting Anti-TSLP Antibody for Severe Asthma Engineered with AI Français
2025-12-01
FierceBiotech
Fierce 15: Where are they now?
2025-10-28
Company data provided by crunchbase