--- title: 'Senior Clinical Trial Manager at Generate Biomedicines' canonical: 'https://feeny.ai/job/senior-clinical-trial-manager-generate-biomedicines-remote-c0vrxewkybbt' type: 'job' last_seen: '2026-10-30' --- # Senior Clinical Trial Manager at Generate Biomedicines - **Company:** Generate Biomedicines - **Location:** Remote - **Compensation:** $140k–$196k - **Work type:** remote - **Posted:** 2026-10-29 - **Last confirmed live:** 2026-10-30 - **Apply:** https://generatebiomedicines.com/open-positions?gh_jid=4725901006 ## Job description The Role: Generate Biomedicines is searching for an enthusiastic and collaborative Senior Clinical Trial Manager to join our Clinical Development Team. This role will report into the Director, Clinical Operations and will work closely with Data Management, Clinical Supply, Regulatory Affairs, and Preclinical Discovery & Development on all late stage trial execution efforts related to our COPD program.  The Senior Clinical Trial Manager will lead the startup, execution, and closeout efforts for Generate’s clinical studies in alignment with organizational and program goals. This role is also responsible for the management of clinical study budgets, timelines, and vendors, as well as the mentorship of junior team members. The successful candidate will be highly organized and detail oriented, possess great communication skills, and a willingness to collaboratively develop process and departmental standards. Here's how you will contribute: - Independently manages the operational aspects of Generate Biomedicines’ clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites, specifically late stage needs in Asthma/COPD. - Leads cross-functional internal study team meetings and meeting deliverables. - Identification, qualification, and selection of clinical trial sites and investigators alongside CRO including management of key relationships. - Leads day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs. - Facilitates investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings. - Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials. - Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials. - Management of clinical study budgets and execution timelines. - Ensures adherence to study timelines and project and program goals. - Attends and leads monitoring oversight visits and effective collaboration with CRO, Investigators, and site staff on any outcomes/findings. - Reviews study reports and metrics to ensure timely collection of clinical data, samples, and lab results. - Collaboration on SOP development and promotion of standardized clinical business tools. - Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs. - Maintenance and oversight of Trial Master File for assigned studies. - Collaborate with QA and cross functional teams to ensure inspection readiness activities for assigned clinical trials, ensuring TMF completeness, audit preparedness, and compliance with GCP, SOPs, and applicable regulatory requirements. - Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards). - Trains and mentors junior staff The Ideal Candidate will have: - Bachelor’s degree required. Advanced scientific degree is preferred - 8+ years of experience in clinical operations, with at least 4+ years in late stage trial operations with a sponsor company - Experience in various therapeutic areas (Respiratory indications a strong plus) - Experience in CRO, vendor and laboratory oversight is required - Motivated self-starter who is capable of flourishing in a fast-paced environment - Creative problem solver with excellent communication and public speaking skills - Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Program/Portfolio Managers, Physicians, etc.) - Ability to travel for up to 30% of time, both domestic and international - Detailed knowledge of GCP. Knowledge of other relevant global regulatory requirements (ie FDA, EMA, and MHRA) is a plus ## 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 base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary 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 Year Salary Range $140,000—$196,000 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 - [Senior Manager, Vendor Management](https://feeny.ai/job/senior-manager-vendor-management-generate-biomedicines-remote-321ee8qrkrzj) - [Director, Clinical Procurement](https://feeny.ai/job/director-clinical-procurement-generate-biomedicines-remote-qakj30d4dthm) - [Senior Director, Clinical Operations Business & Excellence](https://feeny.ai/job/senior-director-clinical-operations-business-excellence-generate-biomedicines-42e1kvgmzdf6) - [Senior Scientist I, Computational Protein Design](https://feeny.ai/job/senior-scientist-i-computational-protein-design-generate-biomedicines-somerville-caa239jvj23x) — Somerville, MA - [Scientist I, Computational Protein Design](https://feeny.ai/job/scientist-i-computational-protein-design-generate-biomedicines-somerville-6n26sf6x6wva) — Somerville, MA - [Scientist II, Functional Bioassays & High Throughput Screening](https://feeny.ai/job/scientist-ii-functional-bioassays-high-throughput-screening-generate-ajjehf28b7v6) — Somerville, MA - [Senior Scientist I, Protein Analytics & Biophysics](https://feeny.ai/job/senior-scientist-i-protein-analytics-biophysics-generate-biomedicines-somerville-84zvsqcb2gzh) — Somerville, MA - [Principal Scientist, Target Binding](https://feeny.ai/job/principal-scientist-target-binding-generate-biomedicines-somerville-nst4sw7htmp7) — Somerville, MA - [Scientist I, Synthetic Biology](https://feeny.ai/job/scientist-i-synthetic-biology-generate-biomedicines-somerville-xfvg8ftyvq3y) — Somerville, MA - [Associate Director, Biotherapeutic Production and Characterization](https://feeny.ai/job/associate-director-biotherapeutic-production-and-characterization-generate-vhxshbh7baa1) — Somerville, MA