Accountabilities:

Provide medical safety leadership and oversight across clinical-stage investigational therapies, including inhaled antifibrotic treatments and combination products targeting pulmonary fibrosis.

Conduct hands-on medical review and assessment of serious adverse events (SAEs), adverse events of special interest (AESIs), deaths, treatment discontinuations, and other medically significant events.

Evaluate seriousness, causality, expectedness, and clinical significance of individual safety cases, ensuring appropriate documentation and follow-up.

Review case narratives and safety listings, applying clinical judgment to distinguish potential drug-related events from underlying disease progression, acute exacerbations, concomitant illnesses, and background events.

Lead ongoing safety surveillance across Phase 1–3 clinical trials, reviewing aggregate adverse events, laboratory abnormalities, vital signs, ECGs, pulmonary safety parameters, and other relevant clinical data.

Review blinded and, when appropriate, unblinded safety information in accordance with established clinical trial procedures.

Provide medical safety input into clinical trial protocols, safety monitoring plans, informed consent documents, protocol amendments, and risk mitigation strategies.

Support Data Monitoring Committee (DMC) and Independent Data Monitoring Committee (IDMC) activities, as appropriate.

Lead cross-functional safety review meetings with Clinical Development, Clinical Operations, Biostatistics, and Data Management teams.

Identify, investigate, and evaluate emerging safety signals by integrating individual case information with aggregate clinical, laboratory, and nonclinical data.

Prepare documented medical assessments of potential safety signals and recommend additional investigations, monitoring measures, or risk mitigation strategies.

Lead and maintain ongoing benefit-risk assessments for investigational products, integrating safety, efficacy, pharmacology, and nonclinical findings within the context of the target patient population.

Evaluate the impact of emerging safety findings on dose selection, patient eligibility criteria, trial endpoints, monitoring requirements, and broader clinical development strategies.

Partner with Biostatistics to interpret safety trends across treatment exposure, dosage, duration, patient subgroups, and relevant risk factors.

Provide medical leadership for Development Safety Update Reports (DSURs), Investigator's Brochures (IBs), Reference Safety Information, IND safety reporting, and Suspected Unexpected Serious Adverse Reaction (SUSAR) assessments.

Contribute to integrated safety analyses, expedited safety reporting, and clinical and regulatory submissions, ensuring scientific accuracy and regulatory compliance.

Lead program-level safety governance meetings and prepare medical assessments and presentations for senior management and development committees.

Escalate significant safety concerns promptly and collaborate with clinical leadership, program leads, and executive stakeholders on development decisions.

Serve as the primary medical safety interface across Clinical Development, Pharmacovigilance, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Quality Assurance, and external partners.

Provide medical oversight of outsourced pharmacovigilance activities, including case reviews, escalation procedures, reconciliation processes, vendor deliverables, and quality metrics.

Help establish and maintain scalable, fit-for-purpose pharmacovigilance systems, procedures, safety management plans, and governance processes appropriate for a growing biotechnology organization.

Support pharmacovigilance audits, regulatory inspections, corrective and preventive actions (CAPAs), and documentation of medical safety decisions.

Provide medical safety expertise during interactions with the FDA, EMA, and other international health authorities, including regulatory meetings, safety-related questions, and submission preparation.

Recognize and appropriately escalate potentially material nonpublic information (MNPI), ensuring timely communication of significant safety findings to relevant functional leaders and executive stakeholders in accordance with disclosure procedures.

How Jobgether works

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

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