Associate Director, Pharmacovigilance

Overview

Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Position Summary

This position provides the PV expertise needed to perform independent medical/scientific review of safety information from any source to evaluate medical contents and lead the process of identifying potential safety signals at both single and aggregate case level. This position also independently leads safety activities and benefit-risk strategies for assigned program(s), including chair the program Safety Surveillance Committee(s) and significantly contributes to Independent Data and Safety Monitoring Committee(s) meetings. In addition, this position will prepare and review aggregate safety documents as well as safety sections of relevant clinical trial documents and regulatory filings. This position implements PV leadership skills towards establishing and strengthening PV infrastructure while forming interpersonal cross-functional relationships that foster collaboration both internally and externally with vendors.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned programs by chairing the program Safety Surveillance Committee(s) and participating in Independent Data and Safety Monitoring Committee(s) for assigned investigational products.
• Provide medical input and review aggregate reports (PBRER, DSUR, 120-day safety update reports), safety sections of relevant clinical trial documents (e.g., protocols, clinical study reports, investigator brochures, informed consent forms), and support regulatory filings (e.g., clinical trial applications, marketing authorization applications) including providing input to statistical analysis plan, safety table shells, and integrated safety data review.
• Serve as safety medical expert to evaluate adverse events for all assigned programs from any source, including provide company causality assessment aligned with global regulations, determine whether the events are accurately reported and captured, and confirm events are correctly coded with MedDRA.
• Prepare and review answers to safety queries from regulatory authorities as needed.
• Lead safety strategy preparation for pre-submission meetings, Advisory Committee meetings, and Scientific Advice meetings.
• Provide PV expertise regarding potential post-approval safety commitments including non-interventional safety studies.
• Represent PV in clinical development projects providing expert medical guidance on safety matters for investigational products.
• Lead signal management processes, including independently performing routine review of safety data for assigned products and detection and evaluation of new safety signals.
• Conduct medical evaluation of relevant safety-related information from toxicology and non-clinical studies.
• Provide leadership oversight of safety vendors and provide back-up for the Head of PV.
• Participate in continuous improvement activities of self as well as for PV department including systems design and quality management activities.
• Lead PV activities associated with regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.

Qualifications

• MD/equivalent required. Postgraduate qualification or experience in gene therapy/cell therapy clinical development or related specialty desirable.
• 8 or more years of PV experience.
• Expert knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
• Excellent verbal and written communication skills.
• Demonstrated leadership skills and process/infrastructure build
• Proficient ability to leverage the range of available tools to investigate safety concerns.
• Understanding of regulatory requirements for safety assessment and action.
• Strong scientific analytical reasoning skills.
• Strong interpersonal skills and ability to collaborate cross-functionally
• Proven track record of effective vendor oversight
• Ability to work on multiple projects in parallel with shifting priorities.
• Excellent attention to detail.

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.