Associate Director, PV Clinical Trials Operations
Viridian Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
Description
At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
Reporting to the Senior Director, PV Operations, the Associate Director, PV Clinical Trials Operations will be responsible for managing the clinical trial pharmacovigilance operational process, supporting the clinical teams, maintaining and adhering to global regulations, and assisting in the oversight of vendor services.
This role may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.
Responsibilities (including, but not limited to): Lead PV Clinical Trials operational activities, including SAE data reporting and reconciliation between safety and clinical databases Review Study level documents including Protocols, Study Management Plans, TMF Plans, and SAE Reconciliation Plans Develop/Oversee development of study specific SAE and Pregnancy forms Liaise with data management, clinical operations, PV MDs and PV Scientists, Clinical Development as needed Represent PV Operations on program study teams Perform oversight tasks of daily study specific activities including SAE reconciliation, study set up, query management, eTMF filing etc. Assist in safety review and aggregate reporting, as needed Act as the process owner and SME for PV Clinical Trials Operations in audits and inspections Develop and maintain SOPs, and data entry conventions relating to the management of PV clinical trials operations Ensure compliance and timely implementation of CAPAs as needed when they arise Review and provide input on SDEAs, PVAs, Charters, and associated Safety Agreement documents as needed. Work closely with PV Physicians and PV Scientists on study related operational activities. Ensure operational processes are in place to handle all potential safety reporting, prior to study start, including communication with PV vendor to set-up the safety database, expectedness list preparation in collaboration with PV MD, and unblinding process set-up Requirements
Requires 10+ years prior experience in pharmacovigilance, Advanced degree in a scientific discipline (e.g., PharmD, MD, PhD) preferred; Minimum Bachelor's degree required. Demonstrated knowledge of relevant FDA, EMA, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both Safety reporting and processing for clinical trial environments Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus/ArisG/Veeva Safety) Development and review of SOPs and Work Instructions Vendor Management oversight responsibilities required. Experience with setting up a post-marketing PV vendor and global safety database preferred Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities Excellent verbal and written communication skills including the ability to present to both internal and external partners Strong analytical and problem-solving skills Ability to work effectively in a fast-paced, dynamic environment High integrity and commitment to patient safety Strong commitment to ethical standards Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) Ability to travel up to 10-15% The salary range for this position is commensurate with experience Viridian offers a comprehensive benefits package including:
Competitive pay and stock options for all employees Competitive medical, dental, and vision coverage Fertility and mental health programs Short- and long-term disability coverage Life, Travel and AD&D 401(k) Company Match with immediate company vest Employee Stock Purchase plan Generous vacation plan and paid company holiday shutdowns Various mental, financial, and proactive physical health programs covered by Viridian
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
Reporting to the Senior Director, PV Operations, the Associate Director, PV Clinical Trials Operations will be responsible for managing the clinical trial pharmacovigilance operational process, supporting the clinical teams, maintaining and adhering to global regulations, and assisting in the oversight of vendor services.
This role may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.
Responsibilities (including, but not limited to): Lead PV Clinical Trials operational activities, including SAE data reporting and reconciliation between safety and clinical databases Review Study level documents including Protocols, Study Management Plans, TMF Plans, and SAE Reconciliation Plans Develop/Oversee development of study specific SAE and Pregnancy forms Liaise with data management, clinical operations, PV MDs and PV Scientists, Clinical Development as needed Represent PV Operations on program study teams Perform oversight tasks of daily study specific activities including SAE reconciliation, study set up, query management, eTMF filing etc. Assist in safety review and aggregate reporting, as needed Act as the process owner and SME for PV Clinical Trials Operations in audits and inspections Develop and maintain SOPs, and data entry conventions relating to the management of PV clinical trials operations Ensure compliance and timely implementation of CAPAs as needed when they arise Review and provide input on SDEAs, PVAs, Charters, and associated Safety Agreement documents as needed. Work closely with PV Physicians and PV Scientists on study related operational activities. Ensure operational processes are in place to handle all potential safety reporting, prior to study start, including communication with PV vendor to set-up the safety database, expectedness list preparation in collaboration with PV MD, and unblinding process set-up Requirements
Requires 10+ years prior experience in pharmacovigilance, Advanced degree in a scientific discipline (e.g., PharmD, MD, PhD) preferred; Minimum Bachelor's degree required. Demonstrated knowledge of relevant FDA, EMA, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both Safety reporting and processing for clinical trial environments Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus/ArisG/Veeva Safety) Development and review of SOPs and Work Instructions Vendor Management oversight responsibilities required. Experience with setting up a post-marketing PV vendor and global safety database preferred Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities Excellent verbal and written communication skills including the ability to present to both internal and external partners Strong analytical and problem-solving skills Ability to work effectively in a fast-paced, dynamic environment High integrity and commitment to patient safety Strong commitment to ethical standards Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) Ability to travel up to 10-15% The salary range for this position is commensurate with experience Viridian offers a comprehensive benefits package including:
Competitive pay and stock options for all employees Competitive medical, dental, and vision coverage Fertility and mental health programs Short- and long-term disability coverage Life, Travel and AD&D 401(k) Company Match with immediate company vest Employee Stock Purchase plan Generous vacation plan and paid company holiday shutdowns Various mental, financial, and proactive physical health programs covered by Viridian
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.