--- title: 'Director, Clinical Operations at Generate Biomedicines' canonical: 'https://feeny.ai/job/director-clinical-operations-generate-biomedicines-remote-s8tfcjh9tsm4' type: 'job' last_seen: '2026-09-26' --- # Director, Clinical Operations at Generate Biomedicines - **Company:** Generate Biomedicines - **Location:** Remote - **Compensation:** $186k–$279k - **Work type:** remote - **Posted:** 2026-09-18 - **Last confirmed live:** 2026-09-26 - **Apply:** https://generatebiomedicines.com/open-positions?gh_jid=4714144006 ## Job description 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. 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. ## #LI-RT1 Compensation: 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. Per Hour Pay Range $186,000—$279,000 USD ## About Generate Biomedicines ## Company Overview - **One-liner**: Generate Biomedicines is a clinical-stage generative biology company pioneering the use of machine learning to design and develop protein-based medicines on demand. - **Entity Type**: Public (ticker: GBIO) - **Headquarters**: Somerville, Massachusetts, USA (Boynton Yards and Andover locations) - **Founded**: 2018 - **Founders**: Gevorg Grigoryan, Daria Hazuda, and others ## Core Business - **Primary industry**: Biotechnology / Drug Discovery & Development - **Target customers**: B2B (pharmaceutical partners) and patients (via clinical programs) - **Mission statement**: "We don’t discover medicines—we design them," with a belief that speed is a moral obligation to patients. ## Products & Services - **[Generate Platform™]**: An integrated computational and biohardware innovation stack that uses generative biology to design proteins with defined biological intent. It can generate up to a billion designed variants per cycle with cycle times as fast as ~8 days. - **[GB-0895 (Anti-TSLP Antibody)]**: A next-generation anti-TSLP monoclonal antibody for severe asthma and COPD, currently in global Phase 3 trials. Designed for ultra-high affinity (106 fM binding, 20x improvement over tezepelumab) and an extended half-life (98 days, longest known among TSLP-targeting therapies), enabling twice-yearly subcutaneous dosing. - **[GB-5267 (MUC-16 Armored CAR-T)]**: A cell therapy candidate for metastatic ovarian cancer, expected to enter Phase 1 in 1H26. - **[GB-4362 (Free MMAE Toxin Neutralizer)]**: A first-in-class neutralizer designed for combination with MMAE-based antibody-drug conjugates (ADCs), with Phase 1 initiation in bladder cancer expected 1H26. ## Market Standing - **Valuation/Market Cap**: Not publicly disclosed; IPO in February 2026 raised net proceeds of approximately $370 million. - **Key Metric**: $221.5 million cash balance at YE 2025, plus ~$370 million from IPO (early 2026). - **Notable Investors/Partners**: Strategic collaborations with Amgen, Novartis, MD Anderson Cancer Center, and Roswell Park Comprehensive Cancer Center. - **Growth Signals**: 5 clinical-stage programs enabled by the platform; initiated global Phase 3 studies for GB-0895; operating out of 140k+ square feet of lab and office space; has studied millions of proteins and generated 42,000 proteins built and tested. ## Competitive Advantages - **Fully integrated computational-biohardware loop**: Machine learning drives generative design, which feeds directly into high-throughput experimentation (including proprietary CryoEM with four of the best microscopes in the world), and results continuously train the AI system — a "living feedback loop" that compounds over time. - **Multimodal platform**: Can generate candidates across antibodies, CAR-T, and other protein modalities from a single core technology, enabling a pipeline that covers both immunology and oncology. - **Record speed and scale**: Capable of generating up to a billion designed variants in ~8-day cycles, dramatically reducing the time and cost traditionally associated with drug discovery. - **First-mover in next-gen anti-TSLP**: First known next-generation anti-TSLP antibody to enter the clinic (GB-0895) with a differentiated half-life profile that could enable twice-yearly dosing, a significant competitive edge in a large market. ## Strategic Focus - **Clinical execution**: Advancing GB-0895 through global Phase 3 trials in severe asthma (with data in 2H27/1H28) and initiating late-stage development in COPD. - **Pipeline expansion**: Moving GB-5267 (CAR-T) and GB-4362 (ADC neutralizer) into Phase 1 in 2026, expanding the platform's therapeutic scope. - **Platform scaling**: Continuing to refine the generative biology engine to unlock new modalities and therapeutic areas, while deepening existing strategic collaborations with major pharma partners. - **Organizational growth**: Building out the team across computational, wet-lab, clinical, and operational functions to support the growing pipeline. ## Why Work Here - **Mission-driven**: The company is explicit that "speed is not just a competitive advantage—it’s a moral obligation." Employees are directly involved in designing drugs rather than discovering them, with a focus on getting treatments to patients faster. - **Interdisciplinary culture**: The company emphasizes true integration across machine learning, biological engineering, and medicine. As stated on their site, "We are a close-knit group of cross-disciplinary experts... each conversant in one another’s fields, working together to create a new one." - **Cutting-edge technology**: Access to unique computational and biohardware infrastructure, including "the four best CryoEM microscopes in the world" and a high-throughput experimental loop that powers AI training in real-time. - **Values-driven leadership**: Explicit leadership behaviors include "value the knowledge we gain more than the knowledge we have," "bring creativity, tenacity, and ingenuity to every challenge," and "hold oneself and others to an obligation to dissent." - **Hybrid/office policy**: Not explicitly stated, but the company operates large physical facilities in Somerville and Andover, MA, and offers free parking, monthly subway passes, or subsidized commuter rail passes, suggesting a significant on-site expectation. - **Comprehensive benefits**: Competitive pay, employee stock option plan, health/vision/dental insurance, long- and short-term disability, life insurance, EAP, retirement savings, paid parental/adoption/caregiver leave, free weekly lunch, and stocked kitchen. - **Growth trajectory**: As a newly public company with a cash-rich balance sheet and multiple catalysts over the next 12–24 months, the company offers significant career growth potential for those who want to be part of building a "transcendent company" that redefines an industry. ## Sources 1. [generatebiomedicines.com](https://generatebiomedicines.com/) 2. [generatebiomedicines.com/careers](https://generatebiomedicines.com/careers) 3. [generatebiomedicines.com/about-us](https://generatebiomedicines.com/about-us) 4. [investors.generatebiomedicines.com](https://investors.generatebiomedicines.com/) 5. [Non-Confidential Overview (April 2026)](https://investors.generatebiomedicines.com/wp-content/uploads/2026/04/Generate-Biomedicines-Non-Confidential-Overview_April-2026-1.pdf) ## Other roles at Generate Biomedicines - [Director, Wet Lab Engineering](https://feeny.ai/job/director-wet-lab-engineering-generate-biomedicines-somerville-ac89ba7e1ywd) — Somerville, MA - [Associate Director, Clinical Operations](https://feeny.ai/job/associate-director-clinical-operations-generate-biomedicines-remote-wv0n1zc42hm9) - [Senior Manager, Clinical Data Management](https://feeny.ai/job/senior-manager-clinical-data-management-generate-biomedicines-remote-t922kj0yrt6x) - [Senior Director, GMP Quality](https://feeny.ai/job/senior-director-gmp-quality-generate-biomedicines-somerville-fc88949dnbya) — Somerville, MA - [Senior Director, Protein Analytics & Biophysics](https://feeny.ai/job/senior-director-protein-analytics-biophysics-generate-biomedicines-somerville-svzx43cekjwx) — Somerville, MA - [Senior Director, Medical Monitor (Respiratory indications)](https://feeny.ai/job/senior-director-medical-monitor-respiratory-indications-generate-biomedicines-7fsgqef53wnk) - [Senior Scientist I, Biotherapeutic Production Technologies](https://feeny.ai/job/senior-scientist-i-biotherapeutic-production-technologies-generate-biomedicines-bv9g98d0ty9p) — Andover, MA - [Senior Director, Analytical Development](https://feeny.ai/job/senior-director-analytical-development-generate-biomedicines-somerville-zvvqdh5c10xe) — Somerville, MA - [Vice President, Head of Immunology and Inflammation Development](https://feeny.ai/job/vice-president-head-of-immunology-and-inflammation-development-generate-0rh42ghav49e) - [Director, Clinical Scientist (Respiratory indications)](https://feeny.ai/job/director-clinical-scientist-respiratory-indications-generate-biomedicines-remote-sfd31c7p5ean)