Director, Clinical Operations

Keros Therapeutics•Lexington, MA

67d•$205,000 - $239,000

About The Position

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients. Job Summary As an operational leader of the cross-functional Clinical Study Sub Team, the Director Clin. Ops. (DCO) will be responsible for the execution strategy of assigned clinical trials to achieve overall program and corporate objectives. The DCO will lead an assigned operational team and have direct reports, e.g. Clinical Trial Leads/Managers, Clinical Trial Associates. The DCO will represent operational perspectives at cross functional teams, to help ensure high quality, trials are well designed and planned with clear objectives, timelines, budgets and deliverables. The DCO will drive operational excellence through process improvement, sharing best practices, and proactive planning and risk management. The DCO is the primary point of escalation for resolution of trial management operational issues. This role will interact with functional leaders and present to the executive committee etc. as necessary.

Requirements

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.

Nice To Haves

Experience in pediatric and/or rare diseases.

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.