Associate Director, Clinical Operations Lead -Asthma

Generate Biomedicines•Somerville, MA

About The Position

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: We are expanding our late-stage development organization and adding a new Associate Director, Clinical Operations Lead to support global execution for our asthma program. In this individual contributor role, you will serve as the operational leader for complex, late-stage clinical trials—owning strategy, planning, execution, quality, and delivery. You’ll collaborate cross-functionally and with CRO partners to ensure studies are executed with rigor, efficiency, and patient-first focus.

Requirements

8–12+ years of clinical operations experience with at least 6 years of direct leadership in leading cross functional teams in Late Phase global studies.
Late Phase Respiratory or immunology therapeutic area experience.
Demonstrated expertise in late-phase study execution, regulatory interactions, and oversight of CROs and vendors.
Strong leadership, strategic planning, communication, and problem-solving skills.
Ability to work independently while orchestrating complex cross-functional execution.
Pharmaceutical industry experience and working knowledge of ICH/GCP regulations
Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred.

Nice To Haves

Experience in high-growth or early-build clinical development organizations.
Familiarity with digital trial tools, decentralized approaches, or innovative patient-engagement models.

Responsibilities

Serve as the operational lead for global Phase 3 asthma studies, ensuring successful planning, execution, and delivery of study objectives.
Develop overall study strategy, timelines, and operational plans aligned with program goals and regulatory expectations.
Lead scenario planning, risk assessment, and proactive mitigation efforts to maintain quality and timelines.
Review and approve key trial documents, including protocols, amendments, plans, and manuals.
Lead and coordinate multidisciplinary study teams (clinical operations, data management, biostatistics, safety, regulatory, medical, quality).
Act as the central point of accountability across internal stakeholders, CRO partners, and external vendors.
Enable effective communication, decision-making, and timely issue escalation across the study team.
Oversee study start-up, site identification, enrollment strategy, monitoring plans, and patient engagement initiatives.
Ensure study conduct follows ICH-GCP, SOPs, and global regulatory requirements.
Manage study budget, vendor performance, timelines, and operational quality metrics.
Identify and manage trial risks, as well as oversee maintenance of issue, action and decision logs.
Assist in audit preparation and ensure corrective and preventive actions (CAPAs) are implemented.
Partner closely with data management and biostatistics to ensure data quality, timely database lock, and high-quality deliverables.
Drive inspection readiness and continuous study health assessments.
Ensure accuracy and completeness of submission-supporting documents, reports, and responses.
Provide operational oversight of CROs and other third-party vendors, ensuring performance and deliverables meet expectations.
Contribute to vendor selection, scope development, contracting, and ongoing governance.
Provide mentorship and operational guidance to junior team members and cross-functional partners.
Share best practices and champion process improvements across the clinical operations function.