Clinical Development Scientist Remote/Waltham, MA

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.

Reporting to the VP of Clinical Development, the Clinical Development Scientist will support all aspects of clinical development (safety, science, and operations), including the safety and pharmacovigilance team and trial activities. Additionally, the Clinical Development Scientist will author and review key trial data-related documents and be responsible for the life cycle management of these documents.

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):

• Contribute to the development of clinical trial strategies and study design and work with the VP of Clinical Development in study protocol development, Investigator’s Brochure updates, procedure manual development, Clinical Study Report development and scientific strategy
• Support the VP of Clinical Development in collaborating with clinical leadership and cross-functional study teams to plan and execute clinical trials, with scientific integrity, from protocol concept through the clinical study report
• Collaborate closely with Clinical Operations colleagues on clinical trial activities and timelines, including Informed consent development and review, data management activities and review of data management plans and other documents, and management of clinical development document deliverables to meet the operational needs of the program
• Support Clinical Development in the 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; identification and prevention of protocol deviations; and resolution of issues
• Collaborate closely with Safety/Pharmacovigilance colleagues on clinical trial activities and timelines, including monitoring data to characterize safety information, in collaboration with the Medical Monitor and management of safety communications with clinical investigators
• Contribute to overall clinical data review including data listings review to detect data trends and ensure data quality and coordinate these activities with cross-functional teams and engaged vendors
• Support the interface with preclinical research and clinical development in the evaluation of scientific communication opportunities and management of the review and submission process
• Partner with Viridian safety/PV and regulatory and the safety management vendor for worldwide safety reporting
• Contribute to the preparation of clinical sections of regulatory documents (INDs); prepare for meetings with FDA/EMA
• Stay current with GCP and worldwide regulatory requirements

Requirements

• Requires a Bachelor’s degree in Life Sciences and 10+ years’ experience or Master’s degree with 8+ years’ experience or PhD with 5+ years’ experience (or commensurate with other relevant Life Sciences degree)
• Requires relevant experience in the biotechnology or pharmaceutical industry
• Clinical experience across all phases of therapeutic development for multiple indications, with 2+ years in Clinical Development
• Therapeutic area experience in Ophthalmology is strongly preferred; experience in Immunology or Neurology is a plus
• Proven success record in the execution of clinical development strategies, as well as the successful submission of IND’s
• Experience authoring clinical documents eg, clinical protocols/ synopses, Investigator Brochures’; conducting literature reviews
• Experience supporting drug safety and pharmacovigilance activities
• Thorough knowledge of FDA regulatory requirements, clinical research concepts & practices, and ICH/GCP guidelines
• Experience working with and managing third party vendors, such as CRO’s
• Proven ability for strategic thinking, creative problem-solving, and risk identification & mitigation skills
• Team-oriented and works collaboratively as a team
• Demonstrated strong written and verbal communication skills
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus and drive for results
• Strong attention to detail
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 10-20% domestic and internationally
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

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.