[Hiring] Senior Director, Clinical Safety Physician @Avalyn Pharma

Role Description

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
• Characterization of potential risks

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
• Aggregate safety data

The individual also serves as the medical safety lead across various departments, integrating safety considerations into clinical development strategy and execution.

Responsibilities

• Medical Safety Leadership & Oversight
  • Provide medical leadership and oversight of safety across Avalyn’s clinical-stage investigational products.
  • Perform medical review and assessment of serious adverse events (SAEs) and adverse events of special interest (AESIs).
  • Review case narratives and ensure appropriate follow-up of medically important information.
  • Apply clinical judgment to distinguish drug-related safety findings from underlying disease manifestations.
  • Identify, evaluate, and escalate potentially important safety findings.
• Clinical Trial Safety
  • Provide ongoing safety oversight of Phase 1–3 clinical trials.
  • Review blinded and unblinded safety information as appropriate.
  • Provide medical safety input into clinical trial design and execution.
  • Lead cross-functional safety review meetings.
• Signal Detection & Benefit-Risk Assessment
  • Lead medical safety surveillance across Avalyn’s development programs.
  • Develop documented medical assessments of emerging safety signals.
  • Lead and maintain an evolving benefit-risk assessment for each investigational product.
  • Partner with Biostatistics to interpret safety data.
• Aggregate Safety & Regulatory Reporting
  • Lead medical review of Development Safety Update Reports (DSURs).
  • Provide medical oversight and support IND safety reporting.
  • Ensure medical safety assessments are medically sound and scientifically supported.
• Safety Governance & Cross-Functional Leadership
  • Lead program-level safety review meetings.
  • Ensure significant safety concerns are promptly escalated.
  • Serve as the medical safety lead across various departments.
• PV Vendor Oversight, Infrastructure & Inspection Readiness
  • Provide medical oversight of outsourced pharmacovigilance activities.
  • Help establish and maintain a fit-for-purpose pharmacovigilance system.
  • Support PV audits and inspection readiness.
• Regulatory Interactions
  • Provide medical safety expertise for interactions with health authorities.
  • Participate in regulatory meetings as appropriate.
• Material Nonpublic Information (MNPI)
  • Recognize that safety findings may constitute material nonpublic information.
  • Communicate potentially material safety information to functional leadership.

Qualifications

• 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.
• Demonstrated experience reviewing serious adverse events (SAEs) and individual case safety reports (ICSRs).
• Experience reviewing and providing medical input into Development Safety Update Reports (DSURs).
• Strong working knowledge of applicable ICH safety guidelines, GCP, and safety-reporting requirements.
• Experience in pulmonary diseases, particularly interstitial lung disease (ILD) or idiopathic pulmonary fibrosis (IPF), is 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.
• Must be willing and able to travel domestically and internationally up to 15%.

Requirements

• Takes a hands-on approach to clinical safety.
• Applies strong clinical judgment to distinguish potential drug-related safety findings.
• Interprets emerging safety trends across doses, exposure, duration, and patient populations.
• Exercises sound judgment amid uncertainty and communicates effectively with cross-functional teams.

Benefits

• Proposed pay range: $310,000 — $350,000 USD