Solid Biosciences

Compensation

Full Description

Pharmacovigilance Operations Associate Director – Solid Biosciences  Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.  Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. We are seeking an Pharmacovigilance Operations Associate Director to support and execute global pharmacovigilance operational activities across Solid’s clinical development programs. This role will focus on day-to-day PV operations execution, vendor oversight, and cross-functional coordination. This position will play a key role in ensuring timely and compliant safety operations in support of Solid’s growing gene therapy pipeline This role will report to Sr. Director, Pharmacovigilance Sciences and will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA or remote/ hybrid depending on candidate location and business needs. Key Position Responsibilities  * Execute global pharmacovigilance operational activities for Solid’s clinical-stage gene therapy programs under the direction of PV leadership. * Oversee day-to-day PV operations, including: 1. Case processing oversight for SAEs and AESIs 2. Compliance monitoring for expedited safety reporting (SUSARs) to global health authorities 3. Operational support for periodic safety reports (DSURs, IND Annual Reports, 6-month line listings) * Serve as the primary operational contact for outsourced PV vendors, supporting: 1. Day-to-day vendor oversight and issue resolution 2. Oversight of PV-related SOWs, Safety Management Plans 3. Monitoring of vendor performance against defined KPIs and SOWs 4. Support the migration of safety cases to a new safety database, including coordination with vendors, support of data reconciliation activities, and documentation review under established plans. * Support the development, maintenance, and implementation of PV SOPs, work instructions, and operational processes. * Partner with Clinical Operations, Clinical Development, Regulatory Affairs, Quality, and Biometrics to ensure accurate and timely safety data flow. * Provide operational support for safety governance activities, including: 1. Safety Management Committees (SMCs) 2. DSMB/DMC interactions, as applicable * Support inspection and audit readiness activities, including document preparation, response drafting, and participation in mock inspections. * Assist in tracking and implementing updates related to evolving global PV regulations and guidance. * Provide day-to-day guidance and oversight to other PV staff or contractors, as applicable   Experience Requirements * Bachelor’s degree in a life science or healthcare-related field is required; an advanced degree (PharmD, MPH, RN) is preferred. * Minimum of 3–5 years of pharmacovigilance experience, with hands-on experience managing clinical-stage PV operations, preferably within rare disease and/or gene therapy programs. * Experience supporting Phase 3 clinical trials, including blinded study designs and management of safety operations in compliance with blinding and unblinding procedures, is a plus * Strong working knowledge of global PV regulations and guidance, including: 1. FDA (21 CFR 312, IND safety reporting) 2. EMA (GVP Modules) 3. ICH guidelines (E2A–E2F) * Demonstrated experience overseeing PV vendors and outsourced models. * Experience supporting regulatory inspections and audits. * Familiarity with safety databases (e.g., Argus, ArisG) and EDC-to-safety data reconciliation processes. Key Position Attributes  * Strategic and operational mindset with the ability to “roll up sleeves” in a fast-paced biotech environment. * Strong attention to detail with a high level of accountability and ownership. * Excellent cross-functional communication and collaboration skills. * Ability to interpret and operationalize regulatory guidance into practical, compliant processes. * Comfort operating in ambiguity and contributing to the build-out of new systems and processes. * Patient-focused perspective with an appreciation for the unique safety considerations of gene therapy and rare diseases. * Proven ability to prioritize, manage competing deadlines, and influence without authority.   Compensation  The base compensation range for this role is: $200,000 to $230,000 Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.    Benefits and Solid Advantages  At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.  * Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs  * 401(k) program participation with competitive company matched contributions * Eligibility to participate in Solid’s Employee Stock Purchase Plan  * Mobile phone subsidy for eligible employees  * Tuition Reimbursement  * Vision Coverage  * Life Insurance  * Voluntary Pet Insurance  * Employee Discount Program on Travel, Entertainment, and Services  * Daily Subsidized Lunch Delivery (onsite @ Hood Park)  * Free Onsite Full-Service Gym (onsite @ Hood Park)  * Employee Parking (onsite @ Hood Park)