Description
At Viridian Therapeutics, 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. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
Reporting to the Vice President, Pharmacovigilance, the Medical Director/Sr Medical Director, Drug Safety & Pharmacovigilance will lead a variety of core medical safety activities within the PV organization to support the monitoring and evaluation of the safety profile of assigned products. This position requires an experienced and accomplished safety physician who can provide medical and PV expertise while collaborating with multiple stakeholders, including clinical development, biostatistics, clinical operations and medical affairs. The role will oversee the outsourced PV case processing and medical review, as well as the clinical trial medical monitoring activities for the ongoing and planned Phase 3 clinical trials executed by the CRO.
This role is fully remote for non-local candidates. Travel to headquarters for meetings may be required at the discretion of management.
Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
- Provide medical and scientific expertise in all aspects of Drug Safety and Pharmacovigilance, including contribution to the ongoing worldwide signal detection monitoring, product risk-benefit assessment, and safety assessment activities of assigned products/indications.
- Lead preparation for and running of quarterly Safety Management Team meetings for assigned programs, including the analysis of clinical trial data, non-clinical data, literature reports and competitive intelligence.
- Assist the Vice President, Pharmacovigilance in implementing the overall clinical strategy for lead programs from development, through regulatory submissions and post-commercialization, with an emphasis on mid to late stages of development and commercial products.
- Design and implement safety strategy for clinical studies, including regular review of safety data and responses to safety issues.
- Assist in clinical data review, analysis, and interpretation from a variety of sources to enable program go/no-go decisions.
- Assist in the review of study documents and protocols, regulatory materials, and interpret clinical study data.
- Coordinate safety outputs from the clinical and safety database for signaling activities and for ad hoc requests.
- Contribute to IB and RSI creation and its revisions.
- Accountable for Aggregate Report coordination including scheduling, planning, management of preparation activities, and drafting of assigned safety portions.
- Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues, including contributing authorship and review of Investigator Brochures, DSURs, development plans, clinical protocols, INDs/CTAs, regulatory responses, and risk management plans.
- Coordinate and participate in the development of ad-hoc Health Authority responses.
- Review SAEs and SUSARs, assure outputs from the safety database as well as timely completion of the Analysis of Similar Event Summaries for HA submissions.
- Liaise effectively within Pharmacovigilance and with other cross-functional departments.
- Monitors safety risk minimization measures.
- Assist in covering the needs of medical affairs by helping lead the continued development and execution of a Medical Affairs strategy, including external stakeholder management, communication, patient identification, evidence generation, publications, and medical education.
- Perform other duties as assigned.
Requirements
- Medical Doctor Degree required.
- 7+ years of pharmacovigilance/related experience, including experience in aggregate safety reports, safety signal management/detection activities, critical review of safety data, case processing of SAEs, and preparing other regulatory documents.
- Knowledge of Aggregate Report requirements and experience in the creation of DSURs, PSURs, NDA Periodic Reports, and IND Annual Reports.
- 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.
- Thorough knowledge of relevant EU GVP, FDA and ICH guidelines, including Good Clinical Practices (GCP) guidelines.
- Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus).
- Working knowledge of Risk Management requirements and activities.
- Thorough understanding of the drug development process and context applicable to safety surveillance activities.
- Development and review of SOPs and Work Instructions.
- Vendor Management oversight responsibilities
- Participation in clinical study team meetings and activities.
- 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.
- Hands-on style with proven ability to work in an entrepreneurial environment and ability to manage and outsource work as required.
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Approximately 10-15% travel may be required.
- 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
· Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
· 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.
