Director, Clinical Operations at Generate Biomedicines

About The Role

&lt;p&gt;&lt;strong&gt;The Role:&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;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.&lt;/p&gt;
&lt;p&gt;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.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Here&#39;s how you will contribute:&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Program Leadership&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;• Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies and related development activities.&lt;/p&gt;
&lt;p&gt;• Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives.&lt;/p&gt;
&lt;p&gt;• Accountable for study timelines, budgets, resource allocation, quality metrics, and overall delivery.&lt;/p&gt;
&lt;p&gt;• Lead scenario planning, risk forecasting, and mitigation strategies at the program level.&lt;/p&gt;
&lt;p&gt;• Partner with Clinical Development leadership to inform portfolio-level planning and decision-making.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;People Leadership &amp;amp; Organizational Development&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;• Directly manage and develop Clinical Operations staff (e.g., Clinical Study Leads and/or Clinical Trial Managers).&lt;/p&gt;
&lt;p&gt;• Recruit, hire, onboard, and retain top talent to support late-stage clinical development.&lt;/p&gt;
&lt;p&gt;• Set performance expectations, conduct evaluations, provide coaching, and support career development.&lt;/p&gt;
&lt;p&gt;• Build a culture of accountability, collaboration, and operational excellence.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Cross-Functional Collaboration&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;• Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC.&lt;/p&gt;
&lt;p&gt;• Act as a primary point of accountability across internal stakeholders, CRO partners, and external vendors.&lt;/p&gt;
&lt;p&gt;• Enable effective decision-making, timely escalation, and transparent communication across teams.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Operational Excellence &amp;amp; Risk Management&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;• Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives.&lt;/p&gt;
&lt;p&gt;• Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs.&lt;/p&gt;
&lt;p&gt;• Provide oversight of study budgets, vendor performance, and quality metrics.&lt;/p&gt;
&lt;p&gt;• Establish performance metrics and drive continuous improvement across external partnerships.&lt;/p&gt;
&lt;p&gt;• Lead inspection readiness strategy and support regulatory inspections.&lt;/p&gt;
&lt;p&gt;• Drive proactive issue identification, risk management, and CAPA oversight.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Functional Leadership &amp;amp; Process Improvement&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;• Contribute to Clinical Operations strategy, infrastructure development, and process optimization.&lt;/p&gt;
&lt;p&gt;• Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies.&lt;/p&gt;
&lt;p&gt;• Share best practices and help define standards across the clinical operations organization.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Ideal Candidate will have:&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;• 12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry.&lt;/p&gt;
&lt;p&gt;• Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) is strongly preferred.&lt;/p&gt;
&lt;p&gt;• Significant experience leading global late-phase (Phase 3) studies.&lt;/p&gt;
&lt;p&gt;• Demonstrated success in direct people management, including hiring, performance management, and team development.&lt;/p&gt;
&lt;p&gt;• Proven ability to lead complex cross-functional teams and influence at senior leadership levels.&lt;/p&gt;
&lt;p&gt;• Strong expertise in CRO oversight, global regulatory environments, and inspection readiness.&lt;/p&gt;
&lt;p&gt;• Strategic thinker with strong operational execution skills.&lt;/p&gt;
&lt;p&gt;• Deep working knowledge of ICH/GCP and global clinical development regulations.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Nice to Have&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;• Late-phase respiratory or immunology therapeutic area experience.&lt;/p&gt;
&lt;p&gt;• Experience building or scaling clinical development functions in a high-growth organization.&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;About Generate:Biomedicines&lt;/strong&gt;&lt;/p&gt;
&lt;p class=&quot;markdown prose dark:prose-invert w-full wrap-break-word light markdown-new-styling&quot;&gt;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.&lt;/p&gt;
&lt;p class=&quot;markdown prose dark:prose-invert w-full wrap-break-word light markdown-new-styling&quot;&gt;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.&lt;/p&gt;
&lt;p class=&quot;markdown prose dark:prose-invert w-full wrap-break-word light markdown-new-styling&quot;&gt;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.&lt;/p&gt;
&lt;p&gt;Generate:Biomedicines is &lt;strong&gt;committed to equal employment opportunity&lt;/strong&gt; regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;em&gt;Recruitment &amp;amp; Staffing Agencies&lt;/em&gt;&lt;/strong&gt;&lt;em&gt;: 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.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;#LI-RT1&lt;/p&gt;&lt;div class=&quot;content-pay-transparency&quot;&gt;&lt;div class=&quot;pay-input&quot;&gt;&lt;div class=&quot;description&quot;&gt;&lt;p&gt;&lt;strong&gt;Compensation:&lt;/strong&gt; The hourly pay range provided reflects our current estimate of what we anticipate paying for this non-exempt position. Your actual hourly rate will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.&amp;nbsp;&lt;/p&gt;&lt;/div&gt;&lt;div class=&quot;title&quot;&gt;Per Hour Pay Range&lt;/div&gt;&lt;div class=&quot;pay-range&quot;&gt;&lt;span&gt;$186,000&lt;/span&gt;&lt;span class=&quot;divider&quot;&gt;&amp;mdash;&lt;/span&gt;&lt;span&gt;$279,000 USD&lt;/span&gt;&lt;/div&gt;&lt;/div&gt;&lt;/div&gt;