Senior Director, Clinical Operations

ABOUT GLYCOERA

GlycoEra is a clinical-stage biopharmaceutical company based in Zurich and Boston, advancing novel autoimmune therapeutics built on a proprietary biologics expression platform. Well-funded and scientifically rigorous, we are translating breakthrough science into medicines for diseases with significant unmet need and building a world-class team to match our ambition.

The Senior Director, Clinical Operations will provide strategic and operational leadership for clinical development planning and clinical trial execution across GlycoEra’s pipeline. Reporting to the Chief Medical Officer, he/she will lead and scale a high-performing global clinical operations organization and ensure that studies are delivered with high quality, appropriate speed, fiscal discipline, and full compliance with applicable global regulatory requirements and ICH GCP guidelines. The role carries overall accountability for clinical operations strategy, execution, inspection readiness, and governance of external providers, including CROs, contractors, and consultants, to enable efficient delivery of high-quality data and regulatory-ready trials.

KEY RESPONSIBILITIES

Clinical Operations Leadership

• Provide leadership across global clinical operations and associated capabilities, building an organization aligned with GlycoEra’s development strategy and growth plans.
• Recruit, develop, and retain high-performing clinical operations talent, with accountability for organizational design, succession planning, and team development.
• Establish and continuously improve scalable processes, systems, SOPs, and work instructions to support compliant and efficient trial execution in a growing biotech environment.
• Develop and maintain strong relationships with strategic partners to support high-quality global trial delivery.

Clinical Trial Execution

• Oversee all aspects of global clinical trial execution, including study start-up, site activation, enrollment, vendor oversight, TMF compliance, and study closeout activities.
• Ensure studies are conducted in compliance with ICH GCP, FDA, EMA, and other applicable regulatory requirements.
• Monitor study progress, timelines, risks, quality metrics, and budgets, proactively identifying issues and implementing mitigation strategies as needed.
• Support inspection readiness activities and contribute to regulatory submissions and audit responses.

Vendor & Cross-Functional Management

• Lead selection, oversight, and management of CROs, central labs, vendors, and contractors.
• Build strong relationships with investigators, clinical sites, and external partners to support successful study execution.
• Collaborate cross-functionally to ensure alignment across operational, scientific, and business objectives.

QUALIFICATIONS

Required

• BS/BA in life sciences or related field; advanced degree preferred.
• 10+ years of Clinical Operations experience within biotech or pharmaceutical industry, including global clinical trial management, with a minimum of 5 years in a senior global Clinical Operations role.
• Proven track record of successfully driving the execution of multiple clinical trials within defined timelines and budgets.
• Strong understanding of clinical development processes, ICH GCP guidelines, FDA/EMA regulations, and inspection readiness requirements.
• Experience working within cross-functional, global, development teams.
• Strong organizational, communication, problem-solving, and collaboration skills.
• Ability to operate effectively in a fast-paced, hands-on biotech environment with a high degree of ownership and accountability.

Preferred

• Experience supporting regulatory submissions and health authority interactions.
• Experience with translational and biomarker-driven clinical studies.

ADDITIONAL INFORMATION

Benefits

• Competitive salary and annual target bonus based on goals and performance.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.

Applying

Candidates are encouraged to submit a CV and a brief cover letter. Please include the Job Code: B26020_DCO in the subject of your email and send to ***email_hidden***

Equal Employment Opportunity Information

GlycoEra is committed to equal employment opportunity and values diversity. All information submitted will be treated confidentially. We are committed to making all hiring decisions and other employment decisions on a non-discriminatory basis.

Agency & Recruiter Disclaimer: We do not accept unsolicited resumes from staffing agencies, search firms, or third-party recruiters. Resumes submitted without a prior written agreement and approval will be considered the property of the company, and no fees will be paid.