Senior Director, Clinical Safety Physician

Avalyn Pharma

5d•$310,000 - $350,000

About The Position

The Senior Director, Clinical Safety Physician provides medical leadership and oversight of drug safety across Avalyn’s portfolio of inhaled antifibrotic investigational products: AP01 (inhaled pirfenidone), AP02 (inhaled nintedanib), and AP03 (a fixed-dose combination). The role is accountable for ongoing medical evaluation, surveillance, interpretation, documentation, and communication of emerging safety data, including adverse-event assessment, signal detection, and characterization of potential risks. Safety findings are incorporated into clinical development and risk-management decisions. This hands-on leadership role involves direct review of adverse-event cases, safety listings, and aggregate safety data; identification and assessment of emerging safety signals; and medical recommendations that inform ongoing study conduct and development decisions. The Senior Director 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 partners. The role integrates safety into 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 position reports to the SVP Clinical Development and partners closely with cross-functional leadership. The role includes oversight of safety across Phase 1–3 trials; medical review of serious adverse events, adverse events of special interest, deaths, and other significant events; signal detection and benefit-risk assessment; aggregate safety and regulatory reporting; safety governance; PV vendor oversight and inspection readiness; and support for regulatory interactions. The Senior Director must handle potentially material nonpublic safety information appropriately and ensure timely escalation and communication. Travel domestically and internationally may be required up to 15%.

Requirements

MD or DO required.
A minimum of 10+ years in pharmaceutical or biotechnology clinical development or drug safety, with meaningful pharmacovigilance responsibility and medical safety oversight of interventional clinical trials.
Demonstrated experience reviewing SAEs and individual case safety reports and assessing causality, expectedness, medical significance, signals, and aggregate safety.
Experience reviewing and providing medical input into DSURs, Investigator’s Brochures, clinical study protocols, IND safety reporting, and other safety-related regulatory submissions.
Strong working knowledge of applicable ICH safety guidelines, GCP, MedDRA, and US and international investigational-product safety-reporting requirements.
Hands-on approach to clinical safety, including personal review of individual cases, narratives, listings, laboratory data, and aggregate safety outputs.
Strong clinical judgment in distinguishing potential drug-related safety findings from underlying disease, concomitant illnesses, and background events.
Ability to interpret emerging trends across doses, exposure, duration, and patient populations and translate findings into recommendations affecting trials 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 and handle sensitive information discreetly.
Willingness and ability to travel domestically and internationally up to 15%.

Nice To Haves

Board certification or equivalent clinical specialty qualification.
Experience in pulmonary diseases, particularly interstitial lung disease, idiopathic pulmonary fibrosis, or progressive pulmonary fibrosis.
Experience in rare diseases or inhaled therapeutics.
Phase 2/3 development experience.
Experience interacting with FDA and/or other global regulatory authorities on safety matters.
Experience overseeing and managing outsourced PV organizations and CROs.
Experience operating within a public-company governance structure, including Development Review Committee activities, board-level reporting, and MNPI and disclosure processes.

Responsibilities

Provide medical leadership and oversight of safety across AP01, AP02, and AP03 clinical-stage investigational products.
Review and assess serious adverse events, adverse events of special interest, deaths, adverse-event discontinuations, and other medically significant events, including seriousness, causality, expectedness, and clinical significance.
Review case narratives and ensure appropriate follow-up of medically important information.
Distinguish potential drug-related safety findings from underlying disease manifestations, concomitant illness, and background events.
Identify, evaluate, and escalate potentially important safety findings and advise on their implications for development.
Oversee safety in Phase 1–3 clinical trials through periodic review of aggregate adverse events, laboratory abnormalities, vital signs, ECGs, pulmonary safety parameters, and other relevant data.
Review blinded and, when appropriate, unblinded safety information according to study procedures.
Provide safety input into trial design and execution, including protocols, safety monitoring plans, informed consent documents, and amendments.
Support Data Monitoring Committee and Independent Data Monitoring Committee activities as appropriate.
Lead cross-functional safety review meetings with Clinical Development, Clinical Operations, Biostatistics, and Data Management.
Lead safety surveillance and medically evaluate potential signals using individual cases and aggregate clinical, laboratory, and nonclinical data.
Document assessments of emerging safety signals and recommend further evaluation, monitoring, or risk mitigation.
Lead and maintain benefit-risk assessments for each investigational product, integrating safety with efficacy, pharmacology, and nonclinical information.
Assess potential effects of safety findings on dose selection, eligibility criteria, monitoring, endpoints, trial execution, protocols, risk mitigation, and development strategy.
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.
Provide medical oversight and support for IND safety reporting, SUSAR assessment, and expedited reporting.
Contribute to integrated and aggregate safety analyses and provide safety input to clinical and regulatory submissions.
Ensure medical safety assessments and conclusions are scientifically supported, clearly documented, and suitable for regulatory compliance and defensible development decisions.
Lead program-level safety review meetings and prepare safety assessments and presentations for development and senior-management governance, including the Development Review Committee.
Escalate significant safety concerns and communicate with Clinical Development leadership, Program Leads, and the Chief Medical Officer on safety-related decisions.
Serve as the medical safety lead and primary clinical safety interface across internal functions and external vendors.
Exercise independent medical judgment on safety matters while respecting the autonomous authorities of Medical, Regulatory, and Quality.
Oversee outsourced pharmacovigilance activities, including medical review, escalation, reconciliation, and communication with PV vendors and CROs.
Review and oversee PV plans, procedures, deliverables, quality metrics, and vendor performance; participate in vendor governance and address gaps.
Help establish and maintain fit-for-purpose pharmacovigilance systems and processes for a growing biotech.
Contribute to safety SOPs, work instructions, safety management plans, and governance processes across relevant functions.
Support PV audits, inspection readiness, CAPAs, and documentation of medical safety decisions.
Provide safety expertise in interactions with FDA, EMA, and other health authorities, including responses to safety questions and preparation of briefing materials.
Participate in regulatory meetings as appropriate and contribute safety expertise to INDs, CTAs, and other submissions.
Recognize and appropriately handle safety information that may constitute material nonpublic information.
Communicate potentially material safety information simultaneously to functional leadership and the Program Lead, and ensure it is shared with the ELT in parallel with the Project Team.
Partner with Regulatory leadership on information sharing with the ELT and ensure timely escalation, recognizing that Legal makes the final materiality determination.
Travel domestically and internationally up to 15%.