Senior Director, Clinical Safety Physician

Avalyn Pharma

. Provide medical leadership and oversight of safety across Avalyn’s clinical-stage investigational products, including AP01 inhaled pirfenidone, AP02 nintedanib, and AP03 fixed-dose combination programs .

Posted 11/5/2026full-timeRemote • United StatesSenior💰 $320,000 - $350,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive medical leadership in clinical safety oversight, with a strong focus on pharmacovigilance, regulatory compliance, and safety data interpretation. Proven ability to manage cross-functional teams and provide strategic input into clinical trial design and execution.

Highest-signal resume keywords

MD Or DOPharmacovigilance ExperienceClinical Development OversightRegulatory Submissions ExpertiseStrong Knowledge Of ICH Safety Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical Review Of SAEsSignal EvaluationAggregate Safety AssessmentDevelopment Safety Update Reports (DSURs)Individual Case Safety Reports (ICSRs)Clinical Study ProtocolsIND Safety ReportingPulmonary Disease ExpertisePhase 2/3 Development ExperienceData Monitoring Committee Support

Soft Skills

Effective CommunicationStrong Clinical JudgmentSound Judgment Amid UncertaintyAbility To Build ProcessesDiscretion In Handling Sensitive Information

Tools & Technologies

Pharmacovigilance SystemsSafety Management PlansQuality MetricsGovernance ProcessesClinical Operations Tools

Certifications & Qualifications

Board Certification Or Equivalent Clinical Specialty Qualification

Industry Keywords

Clinical TrialsBiotechnologyPharmaceutical DevelopmentAdverse Event ReportingFDA InteractionsEMA InteractionsGCPMedDRAInterstitial Lung DiseaseRare Diseases

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide medical leadership and oversight of safety across Avalyn’s clinical-stage investigational products, including AP01 inhaled pirfenidone, AP02 nintedanib, and AP03 fixed-dose combination programs
Perform medical review and assessment of SAEs, AESIs, deaths, adverse-event discontinuations, and other medically significant events
Review case narratives and ensure appropriate follow-up of medically important information
Identify, evaluate, and escalate potentially important safety findings and emerging safety signals
Provide ongoing safety oversight of Phase 1–3 clinical trials through review of aggregate adverse events, laboratory abnormalities, vital signs, ECGs, pulmonary safety parameters, and other safety data
Provide safety input into trial design and execution, protocols, safety monitoring plans, informed consent documents, and protocol amendments
Support Data Monitoring Committee and Independent Data Monitoring Committee activities
Lead cross-functional safety review meetings
Lead medical safety surveillance and develop documented assessments of emerging safety signals
Maintain benefit-risk assessments for investigational products
Recommend protocol modifications, risk-mitigation measures, and clinical development strategy changes when warranted
Partner with Biostatistics to interpret safety data by exposure, dose, treatment duration, subpopulation, and risk factors
Lead medical review of DSURs and other periodic safety reports and review safety sections of Investigator’s Brochures and Reference Safety Information
Support IND safety reporting, SUSAR assessment, expedited reporting, and clinical and regulatory submissions
Lead program-level safety review meetings and prepare safety assessments and presentations for governance and senior management
Serve as medical safety lead across Clinical Development, PV, Regulatory, Clinical Operations, Biostatistics, Data Management, Quality, and external vendors
Provide medical oversight of outsourced pharmacovigilance activities, PV plans, procedures, deliverables, quality metrics, and vendor performance
Help establish and maintain a fit-for-purpose pharmacovigilance system and contribute to safety SOPs, work instructions, safety management plans, and governance processes
Support PV audits, inspection readiness, CAPAs, and documentation of medical safety decisions
Provide safety expertise for FDA, EMA, and other health-authority interactions, regulatory meetings, INDs, CTAs, and regulatory submissions
Recognize and appropriately handle material nonpublic safety information, ensuring timely escalation and disclosure coordination
Report to the SVP Clinical Development and partner with cross-functional leadership on portfolio safety oversight

Requirements

What you’ll need

MD or DO required; board certification or equivalent clinical specialty qualification preferred
A minimum of 10+ years in pharmaceutical or biotechnology clinical development or drug safety, with meaningful pharmacovigilance responsibility and experience providing medical safety oversight for interventional clinical trials
Demonstrated experience reviewing serious adverse events (SAEs) and individual case safety reports (ICSRs) and assessing causality, expectedness, and medical significance, along with signal evaluation and aggregate safety assessment
Experience reviewing and providing medical input into Development Safety Update Reports (DSURs), Investigator’s Brochures (IBs), clinical study protocols, IND safety reporting, and other safety-related regulatory submissions
Strong working knowledge of applicable ICH safety guidelines, GCP, MedDRA, and applicable US and international investigational product safety-reporting requirements
Experience in pulmonary diseases, particularly interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), or progressive pulmonary fibrosis (PPF), is preferred
Experience in rare diseases or inhaled therapeutics is valued
Phase 2/3 development experience is strongly preferred
Experience interacting with FDA and/or other global regulatory authorities on safety matters is a plus
Experience overseeing and managing outsourced PV organizations and CROs is preferred
Experience operating within a public-company governance structure, including participation in Development Review Committee (DRC) activities, board-level reporting, material nonpublic information (MNPI), and disclosure processes is preferred
Hands-on approach to clinical safety, including personal review of individual safety cases, narratives, listings, laboratory data, and aggregate safety outputs
Strong clinical judgment distinguishing potential drug-related safety findings from underlying disease, concomitant illnesses, and background events
Ability to interpret emerging safety trends across doses, exposure, duration, and patient populations and translate findings into recommendations affecting trial design, monitoring, and development strategy
Sound judgment amid uncertainty; effective communication with cross-functional teams and senior leadership; ability to build fit-for-purpose processes in a lean, evolving biotech environment while handling sensitive information with discretion
Must be willing and able to travel domestically and internationally up to 15%