Senior Director, Clinical Safety Physician

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Conduct medical reviews and assessments of serious adverse events (SAEs), adverse events of special interest (AESIs), fatalities, adverse-event discontinuations, and other medically significant occurrences.

• Review case narratives and ensure appropriate follow-up on medically important information.

• Identify, evaluate, and escalate potentially significant safety findings and emerging safety signals.

• Oversee ongoing safety of Phase 1–3 clinical trials by reviewing aggregate adverse events, laboratory abnormalities, vital signs, ECGs, pulmonary safety parameters, and other safety data.

• Contribute safety insights to trial design and execution, protocols, safety monitoring plans, informed consent documents, and protocol amendments.

• Support the activities of the Data Monitoring Committee and Independent Data Monitoring Committee.

• Facilitate cross-functional safety review meetings.

• Lead medical safety surveillance and create documented assessments of emerging safety signals.

• Maintain benefit-risk evaluations for investigational products.

• Suggest protocol modifications, risk-mitigation strategies, and changes to clinical development plans when appropriate.

• Collaborate with Biostatistics to interpret safety data based on exposure, dose, treatment duration, subpopulations, and risk factors.

• Oversee medical reviews of Development Safety Update Reports (DSURs) and other periodic safety reports, as well as review safety sections of Investigator’s Brochures and Reference Safety Information.

• Assist with IND safety reporting, assessment of SUSARs, expedited reporting, and clinical and regulatory submissions.

• Lead safety review meetings at the program level and prepare safety assessments and presentations for governance and senior management.

• Act as the medical safety lead across Clinical Development, Pharmacovigilance (PV), Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Quality Assurance, and external vendors.

• Provide medical oversight for outsourced pharmacovigilance activities, including PV plans, procedures, deliverables, quality metrics, and vendor performance.

• Help establish and maintain an effective pharmacovigilance system and contribute to safety standard operating procedures (SOPs), work instructions, safety management plans, and governance processes.

• Support pharmacovigilance audits, inspection readiness, corrective and preventive actions (CAPAs), and documentation of medical safety decisions.

• Offer safety expertise for interactions with the FDA, EMA, and other health authorities, as well as regulatory meetings, INDs, Clinical Trial Applications (CTAs), and regulatory submissions.

• Recognize and appropriately manage material nonpublic safety information, ensuring timely escalation and coordination of disclosures.

• Report to the Senior Vice President of Clinical Development and collaborate with cross-functional leadership on portfolio safety oversight.

⛳️ Requirements

• MD or DO is required; board certification or equivalent clinical specialty qualification is preferred.

• At least 10+ years of experience in pharmaceutical or biotechnology clinical development or drug safety, with significant pharmacovigilance responsibilities and experience in providing medical safety oversight for interventional clinical trials.

• Proven experience in reviewing serious adverse events (SAEs) and individual case safety reports (ICSRs), assessing causality, expectedness, and medical significance, along with signal evaluation and aggregate safety assessments.

• Experience in 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, Good Clinical Practice (GCP), MedDRA, and relevant US and international investigational product safety-reporting requirements.

• Preferred experience in pulmonary diseases, particularly interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), or progressive pulmonary fibrosis (PPF).

• Valued experience in rare diseases or inhaled therapeutics.

• Strongly preferred experience in Phase 2/3 development.

• Experience interacting with the FDA and/or other global regulatory authorities on safety matters is an advantage.

• Preferred experience managing outsourced pharmacovigilance organizations and Contract Research Organizations (CROs).

• Preferred experience operating within a public-company governance structure, including engagement in Development Review Committee (DRC) activities, board-level reporting, handling material nonpublic information (MNPI), and disclosure processes.

• A hands-on approach to clinical safety, including personal review of individual safety cases, narratives, listings, laboratory data, and aggregate safety outputs.

• Strong clinical judgment in differentiating potential drug-related safety findings from underlying diseases, concomitant illnesses, and background events.

• Ability to interpret emerging safety trends across doses, exposure durations, and patient populations, translating findings into recommendations impacting trial design, monitoring, and development strategy.

• Sound judgment in uncertain situations; effective communication with cross-functional teams and senior leadership; ability to build fit-for-purpose processes in a lean, evolving biotech environment while managing sensitive information with discretion.

• Must be willing and able to travel domestically and internationally up to 15% of the time.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance packages.

• Generous paid time off and holiday policies.

• Opportunities for professional development and continuing education.

• Flexible working arrangements and a supportive work environment.