Senior Clinical Trial Manager

Regulatory Toolkit; Somerville (MA); Presencial; USD 140.000 - 196.000; Jornada completa

Descripción de la vacante

Generate Biomedicines seeks a Senior Clinical Trial Manager to lead late-stage COPD/ asthma trial execution. You will manage CROs, central labs, and sites, ensuring startup, enrollment, monitoring, data flow, and timelines align with program goals.

You will supervise cross-functional teams, develop study documents, and oversee budgets while mentoring junior staff. Travel up to 30% domestically and internationally is expected.

Formación

• Bachelor’s degree required; advanced scientific degree preferred.
• 8+ years of experience in clinical operations.
• Experience in late stage trial operations with a sponsor company.
• Experience in CRO, vendor and laboratory oversight is required.
• Able to travel up to 30% domestically and internationally.

Responsabilidades

• Manage operational aspects of clinical trials with CROs, central labs, and sites for late-stage asthma/COPD studies.
• Lead cross-functional study team meetings and deliverables.
• Identify, qualify, and select sites and investigators with CROs; manage key relationships.
• Oversee day-to-day trial execution: startup, enrollment, monitoring, data flow metrics.
• Facilitate investigator meetings, kickoffs, monitoring training, and vendor meetings.
• Develop and review study documents (ICFs, guidelines, manuals, training materials).
• Contribute to protocol amendments, CRFs, IRB/Ethics applications, recruitment materials.
• Manage budgets and execution timelines; ensure adherence to goals.
• Lead monitoring oversight visits and collaboration with CROs, investigators, site staff.
• Review study reports for timely data collection; promote SPA tools and SOPs.
• Create action plans addressing protocol compliance, safety, data, and admin issues.
• Maintain TMF and ensure inspection readiness with QA and regulatory compliance.
• Prepare trial data presentations for management, scientific meetings, and advisory boards.
• Train and mentor junior staff.

Conocimientos

Communication skills

Public speaking

Mentor junior staff

Organizational skills

Interpersonal skills

Attention to detail

Team collaboration

Travel readiness

Educación

Bachelor’s degree

Advanced degree preferred

Descripción del empleo

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 alllate stagetrial execution efforts related toour COPD program. The Senior Clinical Trial Manager will lead the startup, execution, and closeout efforts forGenerate’sclinical 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 communicationskills, 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,biomarkerand specialty laboratories, and clinical trial sites, specificallylate stageneeds in Asthma/COPD.

• Leads cross-functional internal study team meetings and meeting deliverables.

• Identification, qualification, andselectionof 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 sitestart 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 studydocumentse.g.informed consent forms, study guidelines, operations manuals, trainingmaterials.

• 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 ensuretimelycollection 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,dataand administrative issues with investigational sites and CROs.

• Maintenance and oversight ofTrialMaster File for assigned studies.

• Collaborate with QA and cross functional teams to ensureinspectionreadiness activitiesfor assignedclinical 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 andmentorsjunior staff

The Ideal Candidate will have:

• Bachelor’sdegreerequired. 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 isrequired

• Motivated self-starter whois capable of flourishingin 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 (ieFDA, 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.

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