Generate Biomedicines

Leading healthcare data platform architecture, analytics, and cloud transformation initiatives. | Extensive experience in healthcare data systems, cloud architecture, analytics, and leadership, with no specific clinical operations or pharmaceutical industry experience. | About Generate:Biomedicines Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us! Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. The Role: As we expand our late-stage development organization, we are seeking a Director, Clinical Operations– Severe Asthma 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 asthma 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 asthma 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 Trial 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. · 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. Education · Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) strongly preferred. 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. 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 $186,000—$279,000 USD

Lead clinical quality and pharmacovigilance strategy ensuring compliance, inspection readiness, and team leadership. | Extensive experience in clinical quality and pharmacovigilance, with knowledge of global regulations and inspection readiness, along with leadership skills. | About Generate:Biomedicines Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us! Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. The Role: The Senior Director, GCP & GPV will lead clinical quality and pharmacovigilance strategy across development-stage programs. This role ensures global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPV) compliance, provides guidance on clinical trial operations and safety reporting, and fosters a culture of quality, compliance, and patient safety. The Senior Director drives proactive risk identification and mitigation across the clinical development and pharmacovigilance lifecycle, ensuring inspection readiness and effective regulatory engagement. This leader will partner cross-functionally to embed quality and safety considerations in clinical planning and will oversee a small, high-performing team of quality and pharmacovigilance professionals. Here's how you will contribute: Lead GCP and GPV quality strategy and execution across clinical programs, ensuring compliance with FDA, EMA, and other global regulations. Maintain a phase-appropriate Quality Management System (QMS) for clinical and pharmacovigilance activities, including SOPs, training, document control, and vendor oversight. Oversee clinical quality and pharmacovigilance activities: site/vendor audits, deviation management, CAPAs, and safety reporting compliance. Serve as the primary contact for internal teams and CROs/vendors on clinical quality and safety matters. Support EU clinical compliance and collaborate with the Qualified Person (QP) on European clinical supply certification and release. Drive inspection readiness and support regulatory inspections and submissions (IND, CTA, BLA, MAA). Develop and monitor key quality and safety metrics to identify risks, ensure patient safety, and support continuous improvement. Lead, mentor, and develop a small team of GCP/GPV professionals. Partner with Regulatory Affairs to align quality and safety with regulatory strategy. Leadership Responsibilities Set high standards for performance and accountability, ensuring clarity of expectations and outcomes. Recruit, develop, and retain diverse, high-performing team members. Foster transparent, courageous communication and cross-functional collaboration. Encourage adaptability and calculated risk-taking, modeling resilience through change. The Ideal Candidate will have: BS or advanced degree in biology, chemistry, life sciences, or related field. 10+ years in biotech/pharma, with 6+ years in clinical quality and pharmacovigilance leadership. Strong knowledge of GCP, GPV, and global regulatory expectations, including EU regulations. Experience supporting both early- and late-stage development programs. Demonstrated success with inspection readiness and direct interactions with health authorities. Strong communication, collaboration, and leadership skills in a fast-paced, high-growth environment. Nice to Have Prior experience with regulatory submissions. Proven ability to influence cross-functional stakeholders in an outsourced model. Location: This role will be based out of our headquarters in Somerville, MA. Open to hybrid work arrangement (in office 2-3 days/week) Why Join Us This is a unique opportunity to shape and advance a mission-critical function in a rapidly scaling, innovative biotech. You will directly impact the integrity of our clinical programs and contribute to the development of breakthrough medicines that redefine what’s possible in biotherapeutics. 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. #LI-KD1 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. 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 $210,000—$315,000 USD