Senior Director, Drug Safety and Pharmacovigilance at Dyne Therapeutics Waltham, MA (Waltham)
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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more , and follow us on X, LinkedIn and Facebook.
Role Summary
The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety profiles of Dyne products and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing). This role will provide short and longterm strategic leadership of safety surveillance for Dyne's clinical development programs, including resource planning and longrange capability development to ensure high quality characterization of the safety profiles of Dyne molecules and compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management. This role will oversee crossfunctional Signal Detection and Safety Surveillance Teams, guiding the analysis, interpretation and presentation of safety data to stakeholders as needed. This role also contributes to the safety content of regulatory and study documents and collaborates actively with colleagues in numerous crossfunctional departments. This role is based in Waltham, MA without the possibility of being fully remote.
Primary Responsibilities Include
• Conduct and/or oversee activities related to signal detection and evaluation, risk classification, management and communication, including leadership of Signal Detection and Safety Surveillance Teams, as part of continuous benefitrisk evaluation throughout the lifecycle of Dyne products from FirstinHuman (FIH) to postmarketing
• Review safety data of nonclinical studies and from other sources to inform clinical development safety monitoring strategies and plans, including identification of safetyrelated biomarkers
• Contribute to the Safety Governance process through the preparation and presentation of safety data and provision of recommendations for review and approval by the Safety Management Committee
• Perform medical review of ICSRs in Dyne's Global Safety Database including but not limited to case narrative, MedDRA coding, causality, company comment and queries
• Develop Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), and responses to health authorities' requests for safety information
• Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), IB Reference Safety Information (RSI), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, and other relevant documents
• Provide strategic guidance and draft responses to safetyrelated requests and questions from Health Authorities
• Assist in planning the Pharmacovigilance Department budget, develop shortterm and longterm goals for the department in accordance with overall Company and Development strategies
• Review safety content of scientific publications such as posters, abstracts, and manuscripts.
• Participate in crossfunctional projects and teams
• Engage with external consultants and advisors as needed to inform interpretation of emerging safety signals.
• Serve as an exemplary leader, mentor, and trainer
Education and Skills Requirements
• MD is required
• Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including crossfunctional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development
• Experience with safety data visualization tools and other technologies supporting safety surveillance
• Excellent verbal communication and presentation skills with ability to write clearly and concisely, and to formulate sciencebased arguments in addressing questions regarding safety from Health Authorities and other parties, and in characterization of the safety profiles of Dyne molecules in development
• Experience in authoring DSUR and other aggregate safety reports
• Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations, and ability to integrate relevant aspects of these documents into safety surveillance and reporting
• Line management / direct reports experience is strongly preferred
• Indepth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies
• Strong knowledge of statistical methods used in PV
• Proven abilities to lead significant process improvements in PS
• Exceptional interpersonal skills and understanding of team dynamics.
• Understanding and application of pharmacology, chemistry and nonclinical toxicology to effectively inform the conduct of safety surveillance
• Ability to thrive in a fastpaced environment while providing appropriate attention to detail.
• Ability to effectively present recommendations / opinions in group environment both internally and externally
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.
#J-18808-Ljbffr
Apply Now
Apply Now
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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more , and follow us on X, LinkedIn and Facebook.
Role Summary
The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety profiles of Dyne products and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing). This role will provide short and longterm strategic leadership of safety surveillance for Dyne's clinical development programs, including resource planning and longrange capability development to ensure high quality characterization of the safety profiles of Dyne molecules and compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management. This role will oversee crossfunctional Signal Detection and Safety Surveillance Teams, guiding the analysis, interpretation and presentation of safety data to stakeholders as needed. This role also contributes to the safety content of regulatory and study documents and collaborates actively with colleagues in numerous crossfunctional departments. This role is based in Waltham, MA without the possibility of being fully remote.
Primary Responsibilities Include
• Conduct and/or oversee activities related to signal detection and evaluation, risk classification, management and communication, including leadership of Signal Detection and Safety Surveillance Teams, as part of continuous benefitrisk evaluation throughout the lifecycle of Dyne products from FirstinHuman (FIH) to postmarketing
• Review safety data of nonclinical studies and from other sources to inform clinical development safety monitoring strategies and plans, including identification of safetyrelated biomarkers
• Contribute to the Safety Governance process through the preparation and presentation of safety data and provision of recommendations for review and approval by the Safety Management Committee
• Perform medical review of ICSRs in Dyne's Global Safety Database including but not limited to case narrative, MedDRA coding, causality, company comment and queries
• Develop Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), and responses to health authorities' requests for safety information
• Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), IB Reference Safety Information (RSI), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, and other relevant documents
• Provide strategic guidance and draft responses to safetyrelated requests and questions from Health Authorities
• Assist in planning the Pharmacovigilance Department budget, develop shortterm and longterm goals for the department in accordance with overall Company and Development strategies
• Review safety content of scientific publications such as posters, abstracts, and manuscripts.
• Participate in crossfunctional projects and teams
• Engage with external consultants and advisors as needed to inform interpretation of emerging safety signals.
• Serve as an exemplary leader, mentor, and trainer
Education and Skills Requirements
• MD is required
• Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including crossfunctional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development
• Experience with safety data visualization tools and other technologies supporting safety surveillance
• Excellent verbal communication and presentation skills with ability to write clearly and concisely, and to formulate sciencebased arguments in addressing questions regarding safety from Health Authorities and other parties, and in characterization of the safety profiles of Dyne molecules in development
• Experience in authoring DSUR and other aggregate safety reports
• Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations, and ability to integrate relevant aspects of these documents into safety surveillance and reporting
• Line management / direct reports experience is strongly preferred
• Indepth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies
• Strong knowledge of statistical methods used in PV
• Proven abilities to lead significant process improvements in PS
• Exceptional interpersonal skills and understanding of team dynamics.
• Understanding and application of pharmacology, chemistry and nonclinical toxicology to effectively inform the conduct of safety surveillance
• Ability to thrive in a fastpaced environment while providing appropriate attention to detail.
• Ability to effectively present recommendations / opinions in group environment both internally and externally
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.
#J-18808-Ljbffr
Apply Now
Apply Now