Senior Director, Medical Monitor – Respiratory Indications

Generate Biomedicines

Senior Director Medical Monitor ensuring oversight for late-stage clinical trials in asthma and COPD. Working with cross-functional teams to maintain patient safety and protocol compliance in a biopharma setting.

Posted 7/10/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $277,000 - $400,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in asthma and respiratory clinical trial design, oversight, and execution, with a strong focus on patient safety, protocol compliance, and data integrity. Proven ability to lead cross-functional teams and collaborate effectively with internal and external stakeholders.

Highest-signal resume keywords

MDClinical Development ExperienceAsthma Clinical Trial DesignCross-Functional LeadershipRegulatory Document Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial OversightProtocol ComplianceData IntegritySubject Eligibility ReviewStudy Query ManagementClinical Trial Data InterpretationRegulatory FilingsStudy Protocol DevelopmentCore Clinical Document ReviewBiostatistics Collaboration

Soft Skills

Strong Communication SkillsCollaboration Skills

Certifications & Qualifications

Board Certification in PulmonologyBoard Certification in Allergy & Immunology

Industry Keywords

Late-Stage Clinical TrialsCOPDPatient SafetyInspection ReadinessClinical DevelopmentSafety ManagementStudy ExecutionDSURDSMBEndpoint Adjudication

About the role

Key responsibilities & impact

Provide day-to day medical oversight for late-stage clinical trials in asthma and/or COPD ensuring patient safety, protocol compliance, data integrity and inspection readiness
Serve as primary medical contact for clinical sites, investigators, and CROs Perform subject eligibility review, ongoing data reviews, manage study queries, identify and assess protocol deviations
Serve as a member of the Clinical Development, Safety Management and Study Execution teams
Contributing author and key reviewer of core clinical and regulatory documents including IB, ICF, RFI, study protocols, DSUR
Support study oversight committees including DSMB, endpoint adjudication committee, etc.Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
Interpret clinical trial data and contribute to study reports, regulatory filings, and publications

Requirements

What you’ll need

MD (required); board certification in Pulmonology or Allergy & Immunology preferred
8+ years of clinical development experience in the biopharma industry
Extensive expertise in asthma and respiratory clinical trial design, oversight, and execution
Strong cross-functional leadership and communication skills
Proven ability to collaborate with internal teams and external stakeholders.

Benefits

Comp & perks

annual bonus
equity compensation
competitive benefits package