Senior Director, Clinical Safety Physician

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. Requirements: MD or DO degree required; board certification or an equivalent clinical specialty qualification is preferred. At least 10 years of experience in pharmaceutical or biotechnology clinical development or drug safety, including substantial pharmacovigilance responsibilities and medical safety oversight of interventional clinical trials. Demonstrated hands-on experience reviewing serious adverse events (SAEs), individual case safety reports (ICSRs), and safety narratives, including assessments of causality, expectedness, seriousness, and medical significance. Proven experience in safety signal detection, aggregate safety assessments, and ongoing benefit-risk evaluation. 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 ICH safety guidelines, Good Clinical Practice (GCP), MedDRA terminology, and applicable US and international investigational product safety reporting requirements. Experience in Phase 2 and Phase 3 clinical development is strongly preferred. Background in pulmonary diseases, particularly interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), or progressive pulmonary fibrosis (PPF), is highly desirable. Experience in rare diseases or inhaled therapeutics is an advantage. Previous experience interacting with the FDA or other international regulatory authorities on clinical safety matters is preferred. Experience overseeing outsourced pharmacovigilance organizations, Clinical Research Organizations (CROs), and external safety vendors is preferred. Familiarity with public-company governance structures, including Development Review Committee (DRC) activities, board-level reporting, material nonpublic information (MNPI), and disclosure procedures, is an advantage. Strong clinical judgment and the ability to distinguish potential drug-related safety findings from manifestations of underlying diseases, concomitant conditions, and background events. Demonstrated ability to interpret emerging safety trends across different doses, exposure levels, treatment durations, and patient populations, translating findings into actionable clinical and development recommendations. Strong analytical, scientific, and problem-solving skills, with the ability to independently assess complex safety information and make sound decisions under uncertainty. Excellent communication and stakeholder management skills, including the ability to present complex medical safety findings clearly to cross-functional teams, senior leadership, and external stakeholders. A hands-on, proactive leadership style, with the ability to establish practical processes and systems within a lean, evolving biotechnology environment. High levels of professionalism, discretion, and integrity when handling confidential clinical information and sensitive regulatory matters. Willingness and ability to travel domestically and internationally up to 15%. Benefits: Annual proposed salary range of $310,000–$350,000 USD. Fully remote work opportunity within the United States. Senior leadership position with significant influence over clinical safety strategy and development decisions. Opportunity to contribute to the development of innovative treatments for pulmonary fibrosis and other serious respiratory diseases. Direct collaboration with multidisciplinary clinical, scientific, regulatory, and executive leadership teams. Exposure to global clinical development programs and interactions with major regulatory health authorities. Opportunity to shape and strengthen pharmacovigilance infrastructure within a growing biotechnology organization. Professional growth through involvement in high-impact clinical research and innovative drug development initiatives.