Associate Director, Clinical Operations Lead Asthma

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 millionin 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 this individual contributor role you will serve as the operational leader for complex late-stage clinical trialsowning strategy planning execution quality and delivery. Youll collaborate cross-functionally and with CRO partners to ensure studies are executed with rigor efficiency and patient-first focus.

Heres how you will contribute:

Study Leadership & Strategy

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.

Cross-Functional Collaboration

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.

Operational Execution & Risk Management

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.

Data Quality & Delivery

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.

Stakeholder & Vendor Management

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.

Leadership & Development

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.

The Ideal Candidate will have:

812 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

Education

Bachelors degree required; advanced degree (MS MPH PharmD PhD) preferred.

Nice to Have

Experience in high-growth or early-build clinical development organizations.

Familiarity with digital trial tools decentralized approaches or innovative patient-engagement models.

Who Will Love This Job:

Generate:Biomedicines is pioneering Generative Biology to design and develop novel therapeutics with unprecedented precision. Youll 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. As we expand our late-stage capabilities you will have direct influence on how we build deliver and continuously improve.

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 Companys 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.

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