Senior Director, Clinical Safety Physician

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🇺🇸 United States – Remote

💵 $320k - $350k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Avalyn Pharma

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Avalyn Pharma is a biopharma company dedicated to developing innovative medicines aimed at treating rare lung diseases. The company is currently conducting the MIST Study, a Phase 2b clinical trial assessing the safety and efficacy of an inhaled version of pirfenidone, known as AP01, for patients diagnosed with Progressive Pulmonary Fibrosis (PPF). Through their research, Avalyn Pharma seeks to improve lung function and the overall quality of life for individuals suffering from this serious condition.

📋 Description

• 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

• 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%

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