Senior Director, Clinical Operations

Keros Therapeutics, Inc.; Lexington (MA); On-site; USD 253,000 - 300,000; Full time

Job summary

Keros Therapeutics, Inc. seeks a Senior Director Clinical Operations (SDCO) to lead planning and execution of assigned clinical trials within a cross-functional program team, ensuring timelines, budget, and quality.

The SDCO will manage internal teams and CROs, drive process improvements, and serve as escalation point for trial management issues, while upholding GCP and inspection readiness.

Strong leadership, global trial experience (Phase 1–3), and deep regulatory knowledge are required.

Qualifications

• 12+ years of clinical operations experience in biotech/pharma/CRO sectors.
• Global Phase 1/2/3 study experience.
• 5+ years of people management experience.
• Understanding of FDA, EMEA, GDPR, ICH and GCP regulations and guidelines.

Responsibilities

• Lead cross-functional Program Team to meet timelines, budget and quality/compliance standards.
• Represent clinical operations at internal and external meetings related to assigned topics.
• Determine vendor strategy and participate in vendor selection, develop scope of work.
• Oversee and manage assigned Clinical Operations resources.

Skills

Leadership

Program management

Clinical operations

Vendor management

Regulatory knowledge

Education

BA/BS in clinical or scientific discipline

Job description

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 the leader of the cross-functional Clinical Program Team, the Senior Director Clinical Operations (SDCO) will lead the planning and execution strategy of assigned clinical trials to achieve overall program and corporate objectives. The SDCO will lead an assigned team internally as well as designated CRO/vendors. The SDCO will represent operational perspectives at the cross functional Program Team (or similar) ensuring high quality, feasible trials are planned with clear timelines, budget and deliverables. The SDCO will drive operational excellence through process improvement, sharing best practices, and proactive planning. The SDCO is the primary point of escalation for resolution of trial management operational issues. The SDCO may have direct reports.

Primary Responsibilities

• Independently leads and manages the cross-functional Program Team to ensure deliverables are met within the established timelines, budget and quality/compliance standards.
• Represents clinical operations at external and internal meetings related to assigned clinical topics.
• Determines the clinical vendor strategy for assigned studies/program; participates in the evaluation and selection of vendors, develops scope of work.
• Oversees and manages assigned Clinical Operations resources.
• Serves as escalation point for clinical vendors.
• Represents clinical program at internal governance meetings.
• Contributes to the development and approval of clinical trial documents by providing operational expertise and input to ensure high-quality plans that lead to efficient processes and procedures.
• Responsible to help ensure clinical trial protocol(s) go through the requisite review and approvals.
• Guides the development of trial related materials and scientific trial related documents (e.g. vendor charters, training and subject recruitment materials.
• Contributes to the study safety and data review plans.
• Actively contributes to site and country feasibility, strategy and selection.
• Guides the team to overcome obstacles and risks through risk identification, mitigation planning, proactive team communication and creative problem solving.
• Ensure Good Clinical Practice and inspection readiness across studies.
• Develop and oversee implementation of corrective actions to support good data quality.
• Study budget management including spending and forecasting and contract management.
• Contributes to the development and assessment of Key Performance Indicators/Metrics
• Identifies areas for process improvements within and adjacent to clinical operations.
• Initiates projects that help to build the company culture and integrate the clinical operations team.

Core Competencies (Required Skills)

• Minimum of 12 years of clinical operations experience within the biotech/pharmaceutical/CRO sector(s)
• Phase 1/2/3 global clinical study experience
• 5+ years of people management experience
• Experience in rare and/or complex diseases/trials
• Understanding of FDA, EMEA, GDPR, ICH and GCP regulations and guidelines

Preferred Skills

• Experience in pediatric and/or neuromuscular disorders

Education Requirements

• BA/BS in a clinical or scientific discipline

Potential base pay range

$253,000 — $300,000 USD

Our Diversity, Equity & Inclusion Mission Statement:

Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Recruitment & Staffing Agencies:

Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.