Position Overview: The Senior Director, Clinical Safety Physician provides medical leadership and oversight of drug safety across Avalyn's portfolio of inhaled antifibrotic investigational products. The role is accountable for the ongoing medical evaluation, surveillance, interpretation, documentation, and communication of emerging safety data, including adverse event assessment, signal detection, and characterization of potential risks, ensuring that safety findings are appropriately incorporated into clinical development and risk management decisions. This is a hands-on leadership role suited to a clinical-stage, scaling biotech company. The Senior Director directly reviews adverse event cases, safety listings, and aggregate safety data, identifies and assesses emerging safety signals, and provides medical recommendations to inform ongoing study conduct and development decisions. The individual also serves as the medical safety lead across Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Medical Writing, Quality Assurance, and external CRO and pharmacovigilance (PV) partners. The Senior Director integrates safety considerations into clinical development strategy and execution, establishes and oversees fit-for-purpose pharmacovigilance processes and systems, and provides medical safety leadership in interactions with senior leadership, governance committees, external partners, and health authorities. The Senior Director reports to the SVP Clinical Development and partners closely with cross-functional leadership to ensure appropriate medical oversight of safety across the portfolio.
Responsibilities:Medical Safety Leadership & Oversight- Provide medical leadership and oversight of safety across Avalyn's clinical-stage investigational products, including the inhaled pirfenidone (AP01), nintedanib (AP02), and fixed-dose combination (AP03) programs.
- Perform medical review and assessment of serious adverse events (SAEs), adverse events of special interest (AESIs), deaths, discontinuations due to adverse events, and other medically significant events, including assessment of seriousness, causality, expectedness, and clinical significance.
- Review case narratives and ensure appropriate follow-up of medically important information.
- Apply clinical judgment to distinguish drug-related safety findings from manifestations of the underlying disease (e.g., progression of pulmonary fibrosis, acute exacerbations), concomitant illness, and background events.
- Identify, evaluate, and escalate potentially important safety findings, and provide medical judgment on emerging concerns and their implications for development.
Clinical Trial Safety- Provide ongoing safety oversight of Phase 1-3 clinical trials through periodic review of aggregate adverse events, laboratory abnormalities, vital signs, ECGs, pulmonary safety parameters, and other clinically relevant safety data.
- Review blinded and, when appropriate, unblinded safety information in accordance with established study procedures.
- Provide medical safety input into clinical trial design and execution, including protocols, safety monitoring plans, informed consent documents, and protocol amendments, ensuring appropriate safety assessments, monitoring requirements, and risk mitigation measures are incorporated.
- Provide medical safety expertise and support Data Monitoring Committee (DMC) / Independent Data Monitoring Committee (IDMC) activities as appropriate.
- Lead cross-functional safety review meetings with Clinical Development, Clinical Operations, Biostatistics, and Data Management.
Signal Detection & Benefit-Risk Assessment- Lead medical safety surveillance across Avalyn's development programs; proactively identify, investigate, and medically evaluate potential safety signals, integrating individual cases with aggregate clinical, laboratory, and nonclinical data.
- Develop documented medical assessments of emerging safety signals and recommend additional evaluation, monitoring, or risk-mitigation strategies.
- Lead and maintain an evolving benefit-risk assessment for each investigational product, integrating safety with efficacy, pharmacology, and nonclinical information in the context of the disease and patient population.
- Evaluate how emerging safety findings may affect dose selection, eligibility criteria, safety monitoring, endpoints, trial execution, and provide medical recommendations regarding protocol modifications, risk-mitigation measures, and broader clinical development strategy when warranted.
- Partner with Biostatistics to interpret safety data by exposure, dose, treatment duration, subpopulation, and risk factors.
Aggregate Safety & Regulatory Reporting- Lead medical review of Development Safety Update Reports (DSURs) and other periodic safety reports, and review the safety sections of Investigator's Brochures and Reference Safety Information.
- Provide medical oversight and support IND safety reporting, suspected unexpected serious adverse reactions (SUSAR) assessment, and expedited reporting.
- Contribute to integrated and aggregate safety analyses and provide medical safety input to clinical and regulatory submissions.
- Ensure medical safety assessments and conclusions are medically sound, scientifically supported, and clearly documented to support regulatory compliance and defensible clinical development decisions.
Safety Governance & Cross-Functional Leadership- Lead program-level safety review meetings and prepare safety assessments and presentations for clinical development and senior management governance, including the Development Review Committee (DRC).
- Ensure significant safety concerns are promptly escalated and appropriately communicated to relevant stakeholders; partner with Clinical Development leadership, the Program Leads, and the Chief Medical Officer on safety-related development decisions.
- Serve as the medical safety lead and primary clinical safety interface across Clinical Development, PV, Regulatory, Clinical Operations, Biostatistics, Data Management, Quality, and external vendors.
- Exercise independent medical judgment on safety matters, and respect the autonomous authorities of Medical, Regulatory, and Quality.
PV Vendor Oversight, Infrastructure & Inspection Readiness- Provide medical oversight of outsourced pharmacovigilance activities, including medical review, escalation, reconciliation, and communication processes with PV vendors and CROs.
- Review and provide medical oversight of PV plans, procedures, deliverables, quality metrics, and vendor performance; participate in vendor governance and address performance or process gaps.
- Help establish and maintain a fit-for-purpose pharmacovigilance system appropriate to a growing biotech, without importing unnecessarily burdensome large-pharma infrastructure.
- Contribute to safety SOPs, work instructions, safety management plans, and governance processes, with clear interfaces across PV, Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Quality.
- Support PV audits, inspection readiness, CAPAs, and documentation of medical safety decisions.
Regulatory Interactions- Provide medical safety expertise for interactions with FDA, EMA, and other health authorities, including responses to regulatory safety questions and preparation of briefing materials.
- Participate in regulatory meetings as appropriate and contribute safety expertise to INDs, CTAs, and other regulatory submissions.
Material Nonpublic Information (MNPI)- Recognize that safety findings (e.g., a Data Monitoring Committee recommendation, a clinical hold, a death, or a significant emerging signal) may constitute material nonpublic information and must be handled and disclosed appropriately.
- Communicate potentially material safety information to functional leadership and the Program Lead simultaneously, and ensure it is shared with the Executive Leadership Team (ELT) in parallel with the Project Team.
- Partner with Regulatory leadership, which has autonomy to share information with the ELT immediately when required as a public company.
- Ensure timely escalation of safety information, recognizing that Legal makes the final determination on materiality.
Qualifications:Education & Experience- 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 also 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.
- Takes a hands-on approach to clinical safety, personally reviewing individual safety cases, narratives, listings, laboratory data, and aggregate safety outputs rather than relying solely on vendor assessments or operating at a governance level.
- Applies strong clinical judgment to distinguish potential drug-related safety findings from underlying disease, concomitant illnesses, and background events.
- Interprets emerging safety trends across doses, exposure, duration, and patient populations, translating findings into recommendations affecting trial design, monitoring, and development strategy.
- Exercises sound judgment amid uncertainty, communicates effectively with cross-functional teams and senior leadership, and builds 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%
Proposed pay range
$310,000-$350,000 USD
