Sobre este puesto de Director, Drug Safety & Pharmacovigilance Scientist en Dyne Therapeutics
Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
Primary Responsibilities Include:
- Conduct and lead safety surveillance activities for assigned clinical development programs, including ongoing review of aggregate safety data and identification of emerging safety trends.
- Lead signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management activities across the product lifecycle.
- Review, analyze, and interpret safety information from clinical studies, individual case safety reports (ICSRs), nonclinical studies, scientific literature, and other relevant sources.
- Support medical and scientific review of ICSRs, including evaluation of case narratives, MedDRA coding, causality assessments, expectedness determinations, company comments, and follow-up activities.
- Develop safety monitoring strategies and risk mitigation plans that support effective benefit-risk evaluation.
- Author and contribute to safety signal assessment reports, aggregate safety reports, and safety analyses, including DSURs, PSURs/PBRERs, and responses to health authority safety inquiries.
- Contribute to safety-related sections of clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, reference safety information, clinical study reports, integrated safety summaries, briefing documents, and regulatory submissions.
- Prepare and present safety data, analyses, recommendations, and risk management strategies to cross-functional teams and governance committees.
- Maintain complete, accurate, and inspection-ready documentation of safety surveillance activities, safety decisions, and associated deliverables.
- Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external vendors to integrate safety considerations into study conduct and program strategy.
- Participate in safety governance forums and cross-functional program teams, providing scientific insight and recommendations to support decision-making.
- Influence safety-related discussions across development programs through clear communication of complex safety data and benefit-risk considerations.
- Foster a culture of collaboration, accountability, scientific excellence, and continuous improvement across Drug Safety & Pharmacovigilance and the broader organization.
- Develop, maintain, and enhance pharmacovigilance SOPs, work instructions, templates, and processes in alignment with global regulatory requirements and industry best practices.
- Provide pharmacovigilance training and guidance to internal colleagues and cross-functional partners on safety surveillance, reporting requirements, documentation practices, and inspection readiness.
- Support pharmacovigilance vendor oversight activities, including review of deliverables, quality assessments, issue escalation, and process improvements.
- Monitor evolving pharmacovigilance regulations, guidance, and industry standards and implement appropriate process enhancements to ensure continued compliance and operational effectiveness
Education and Skills Requirements:
- Advanced degree in life sciences, health sciences, pharmacy, medicine, nursing, or a related discipline required; MD, PharmD, PhD, or equivalent advanced degree preferred.
- 10+ years of relevant pharmacovigilance, drug safety, clinical development, or related biotechnology or pharmaceutical industry experience.
- Demonstrated expertise in safety surveillance, signal detection, signal evaluation, aggregate safety review, benefit-risk assessment, and risk management for clinical-stage development programs.
- Experience authoring or contributing to DSURs, PSURs/PBRERs, safety signal assessments, regulatory safety responses, and safety-related sections of clinical or regulatory documents.
- Deep knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GVP, GCP, and applicable safety reporting requirements.
- Experience reviewing, analyzing, and interpreting clinical and safety data, including ICSRs, aggregate datasets, safety listings, tables, figures, and data visualizations.
- Working knowledge of safety databases, MedDRA coding, ICSR workflows, safety management plans, and pharmacovigilance vendor oversight practices.
- Demonstrated ability to apply sound scientific and medical judgment to complex safety information and communicate implications effectively to diverse stakeholders.
- Strong analytical, problem-solving, technical writing, presentation, and project management skills.
- Ability to manage multiple priorities and deliver high-quality work in a dynamic, fast-paced environment.
- Proven success collaborating within matrixed organizations and influencing stakeholders without direct authority.
- Strong attention to detail, accountability, integrity, and commitment to patient safety.
- Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology is preferred.
#LI-Onsite
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
