DescriptionAt 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 VP, Clinical Development, the Associate Medical Director, Clinical Development will support all aspects of clinical development (science and medical), including the generation and review of critical trial-related documents (e.g., investigator brochures, protocols, clinical study reports), contributing to regulatory submissions, and serving as the medical monitor for assigned studies.
This role can be fully remote or based in our Waltham, MA headquarters. 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):- Assist Clinical Development Lead(s) on assigned clinical program/ trials
- Support the development of clinical trial strategies, study designs and scientific strategy
- Contribute to the clinical content of clinical and regulatory documents, including but not limited to protocols, INDs, CTAs, investigator brochures, CSR's; participate in review SAPs, TLF shells, emerging clinical trial data and data interpretation
- Provide medical oversight as medical monitor on assigned trials and the Sponsor's medical representative to multiple vendors and collaborators
- Contribute to preparation and interactions with regulatory authorities
- Contribute to overall review of clinical data including data listings review in collaboration with Safety/PV, cross-functional teams and engaged vendors
- Support activities associated with execution of clinical trials and data collection, including training of the internal team, vendors, and site staff; preparation of case report forms; review of protocol deviations; and resolution of issues
- Partner closely with clinical operations, biostatistics, safety/PV, data management, program management, and research colleagues
- Support management of DSMB activities
- Stay current with GCP and worldwide regulatory requirements
Requirements- Requires a Medical Degree (MD or equivalent)
- 3+ years relevant clinical development experience in the biotechnology or pharmaceutical industry; Immunology or Ophthalmology experience is a plus
- Experience in multiple phases of clinical development desirable
- Knowledge of FDA regulatory requirements, clinical research concepts & practices, and ICH/GCP guidelines
- Ability for creative problem-solving, strategic thinking, risk identification & mitigation skills
- Team-oriented and works collaboratively with cross-functional teams
- Ability to demonstrate flexibility and adaptability in a dynamic environment
- Experience working with and managing third party vendors, such as CRO's
- Strong oral and written communication skills
- Excellent interpersonal/ organizational skills with the ability to multi-task
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 20%
- 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
- 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.
