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 stagetrial 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, possessgreat 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 experiene 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.

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