- 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 benefit-risk evaluation throughout the lifecycle of Dyne products from First-in-Human (FIH) to post-marketing
- Review safety data of non-clinical studies and from other sources to inform clinical development safety monitoring strategies and plans, including identification of safety-related 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 safety-related requests and questions from Health Authorities
- Assist the Head of Pharmacovigilance and PV Operations to prepare and maintain safety related SOPs in compliance with the global safety regulations and guidelines and provide relevant training as needed
- Assist in planning the Pharmacovigilance Department budget, develop short-term and long-term 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 cross-functional 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
- MD is required; completion of an accredited medical or surgical residency program and board certification are preferred
- Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including cross-functional 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 science-based 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
- In-depth 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 non-clinical toxicology to effectively inform the conduct of safety surveillance
- Ability to thrive in a fast-paced environment while providing appropriate attention to detail.
- Ability to effectively present recommendations / opinions in group environment both internally and externally
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Senior Director, Drug Safety and Pharmacovigilance - Waltham, United States - Dyne Therapeutics, Inc.
Description
Company Overview:
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.
With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue.
Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
For more information, please visit , 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 long-term strategic leadership of safety surveillance for Dyne's clinical development programs, including resource planning and long-range 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 cross-functional 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 cross-functional departments.
This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.Primary Responsibilities Include:
Education and Skills Requirements:
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.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position.
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.
