Director, Clinical Operations

The Role:

As we expand our late-stage development organization, we are seeking a Director, Clinical Operations to provide strategic and operational leadership for global Phase 3 development. This role will serve as the operational leader across one or more complex, late-stage studies, with full accountability for study strategy, execution, quality, budget, and delivery.

In addition to program leadership, this role includes direct line management of Clinical Operations professionals, with responsibility for hiring, developing, coaching, and building high-performing teams. The Director will play a key role in shaping operational strategy, advancing functional excellence, and strengthening Generate’s late-stage development capabilities.

Here's how you will contribute:

Program Leadership

• Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies and related development activities.

• Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives.

• Accountable for study timelines, budgets, resource allocation, quality metrics, and overall delivery.

• Lead scenario planning, risk forecasting, and mitigation strategies at the program level.

• Partner with Clinical Development leadership to inform portfolio-level planning and decision-making.

People Leadership & Organizational Development

• Directly manage and develop Clinical Operations staff (e.g., Clinical Study Leads and/or Clinical Trial Managers).

• Recruit, hire, onboard, and retain top talent to support late-stage clinical development.

• Set performance expectations, conduct evaluations, provide coaching, and support career development.

• Build a culture of accountability, collaboration, and operational excellence.

Cross-Functional Collaboration

• Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC.

• Act as a primary point of accountability across internal stakeholders, CRO partners, and external vendors.

• Enable effective decision-making, timely escalation, and transparent communication across teams.

Operational Excellence & Risk Management

• Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives.

• Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs.

• Provide oversight of study budgets, vendor performance, and quality metrics.

• Establish performance metrics and drive continuous improvement across external partnerships.

• Lead inspection readiness strategy and support regulatory inspections.

• Drive proactive issue identification, risk management, and CAPA oversight.

Functional Leadership & Process Improvement

• Contribute to Clinical Operations strategy, infrastructure development, and process optimization.

• Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies.

• Share best practices and help define standards across the clinical operations organization.

The Ideal Candidate will have:

• 12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry.

• Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) is strongly preferred.

• Significant experience leading global late-phase (Phase 3) studies.

• Demonstrated success in direct people management, including hiring, performance management, and team development.

• Proven ability to lead complex cross-functional teams and influence at senior leadership levels.

• Strong expertise in CRO oversight, global regulatory environments, and inspection readiness.

• Strategic thinker with strong operational execution skills.

• Deep working knowledge of ICH/GCP and global clinical development regulations.

Nice to Have

• Late-phase respiratory or immunology therapeutic area experience.

• Experience building or scaling clinical development functions in a high-growth organization.

Who Will Love This Job: 

Generate:Biomedicines is pioneering Generative Biology™ to design and develop novel therapeutics with unprecedented precision. As a Director, you will play a critical role not only in delivering a high-impact late-stage asthma program, but also in shaping how we build and scale our clinical development organization.

You’ll join a collaborative, curious, patient-first team where scientific creativity and operational excellence come together to advance programs with the potential for large-scale impact.

 

About Generate:Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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