Keros Therapeutics · 1 day ago
Director, Clinical Operations
Lexington, MA
Full-time
Onsite
Director/Executive
$205K/yr - $239K/yr
10+ years expKeros Therapeutics is focused on delivering clinical benefits to patients with disorders linked to dysfunctional TGF-β signaling. The Director of Clinical Operations will lead the execution strategy for clinical trials, ensuring quality and compliance while managing a cross-functional team and contributing to the development of clinical trial processes.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Leads and manages the cross-functional Clinical Study Sub Team to ensure deliverables are met within the established timelines, budget and to the requisite quality and compliance standards
Represents clinical operations at appropriate external and internal meetings
Key role in determining the clinical vendor strategy for assigned studies, and participates in the evaluation and selection of vendors, develops scope of work etc
Oversees and manages Clinical Trial Leads/Managers, Clinical Trial Associates, and other assigned roles
Serves as the escalation point for clinical operations
Contributes to the development of clinical trial processes and procedures by providing executional expertise to ensure efficiency and effectiveness throughout protocol design, delivery and completion
Responsible to ensure clinical trial protocol(s) go through all internal review and approval processes
Guides Clinical Trial Leads/Managers in the development of trial related materials e.g. training and recruitment materials
Contribute to the operational study plans e.g. start-up, project and site management, communication
Actively contribute to feasibility exercises and site/country selection
Guides team in managing study risks through risk identification, mitigation planning and proactive operational team communication and creative problem solving
Ensure Good Clinical Practice and inspection readiness across studies including complete documentation and trial master file throughout each study
Primary contact for the Quality Assurance team, working collaboratively to develop an integrated approach that is implemented across each study. Document plans for corrective actions as part of an audit strategy across vendors etc. to achieve excellent data quality
Contribute to study budget management including forecasting, regular review of accruals, and clinical contract management
Actively contributes to the development of innovative solutions to overcome challenges and hurdles within clinical operations and other functions
Qualification
Required
At least 10 years of clinical operations experience with a biotech/pharmaceutical company
Phase 2/3 international clinical study leadership experience
5 years or more of people management
Experience in neuromuscular or related diseases
Vendor oversight and management
Understanding of FDA, EMEA, GDPR, ICH and GCP regulations and guideline
BA/BS in a clinical or scientific discipline
Preferred
Experience in pediatric and/or rare diseases
Company
Keros Therapeutics
Keros is a clinical-stage biopharmaceutical company focusing on the discovery, development, and commercialization of novel treatments.
51-200 employees
H1B Sponsorship
Keros Therapeutics 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 (2)
2024 (2)
2023 (1)
2022 (3)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$379.5MKey Investors
Pontifax
2024-01-03Post Ipo Equity· $140M
2020-11-13Post Ipo Equity· $149.5M
2020-04-07IPO
Leadership Team
Lorena Lerner
Chief Scientific Officer
Recent News
Keros Therapeutics, Inc.
2025-11-21
2025-11-20
Keros Therapeutics, Inc.
2025-11-19
Company data provided by crunchbase