Note: The job is a remote job and is open to candidates in USA. Viridian Therapeutics, Inc. is focused on developing best-in-class medicines for people living with autoimmune and rare diseases. The Clinical Development Scientist will support all aspects of clinical development, including safety, science, and operations, and will be responsible for authoring and reviewing key trial data-related documents.
Responsibilities
- 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
- Responsible for the management of Data Safety Monitoring Board (DSMB) activities including collection of required qualification documents, development of DSMB Charters, coordinating DSMB meetings (scheduling, preparing materials and meeting minute responsibilities)
- 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
Skills
- Requires a Bachelor's degree in Life Sciences and 5+ years' experience or Master's degree with 4+ years' experience or PhD with 2+ 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
- 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
- Therapeutic area experience in Ophthalmology is strongly preferred; experience in Immunology or Neurology is a plus
Benefits
- Competitive pay and stock options for all employees
- Medical, dental, and vision insurance
- 100% Paid Parental Leave
- 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 fertility, mental, financial, and proactive physical health programs
Company Overview