Sr Director, Clinical Development

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 Vice President of Clinical Development, the Sr Director will assist with establishing and leading the clinical development strategy for Viridian’s assigned pipeline program from early-stage development through regulatory approval. The incumbent will perform various duties in support of all aspects of clinical development (science and medical), including the generation and review of key trial data-related documents (investigator brochure, protocol, clinical study reports), contributing to regulatory documents, acting as clinical development and medical lead for assigned program and trial activities, facilitating the communication of medical input during our clinical trials, supporting the planning and preparation of scientific communications, and representing the Company in investigator meetings and other forums. 

This role may be remote or may be based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management. 

Responsibilities (including, but not limited to):

• Serve as the Clinical Development Lead on assigned clinical program/ trials, provide clinical leadership and strategic medical input for all clinical deliverables
• Develop clear scientific and clinical trial strategies in study synopses and protocol development 
• Responsible for the clinical content of clinical and regulatory documents, including but not limited to protocols, INDs, CTAs, investigator brochures, CSR’s; review SAPs and TLF shells, guide the evaluation of emerging clinical trial data, oversee/guide the data interpretation. 
• Contribute to preparation and interactions with regulatory authorities 
• Ensure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, safety/PV, data management, program management, and research colleagues.
• May serve as medical monitor on assigned trials and the Sponsor’s medical representative to multiple vendors and collaborators
• Responsible for review of clinical data in collaboration with Safety and PV
• Ensure all clinical development activities comply with global regulatory requirements and Good Clinical Practice (GCP) guidelines
• Assist in developing and managing clinical development budgets, ensuring cost-effective use of resources
• Stay current with scientific literature, GCP and worldwide regulatory requirements

Requirements

• Requires a Medical Degree (MD or equivalent); U.S. licensure and Board Certification in a relevant therapeutic area are strongly preferred
• A minimum of 10+ years’ experience across all phases of therapeutic development for multiple indications, in a bio-pharmaceutical/pharmaceutical company (minimum 5 years), medical monitoring within a global CRO, and/or clinical practice in a relevant therapeutic area
• Therapeutic area experience in Immunology, Neurology or Autoimmune conditions strongly preferred
• Proven success record in the design and execution of clinical development strategies, as well as the successful submission of IND’s
• Thorough knowledge of FDA and global regulatory requirements, clinical research concepts & practices, and ICH/GCP guidelines
• Superior leadership skills with a proven successful track record of leading cross-functional and high performing teams
• Exceptional strategic thinking, creative problem-solving, and risk identification & mitigation skills
• Team-oriented leader who empowers and inspires others to work collaboratively as a team while establishing clear and consistent goals and objectives
• Ability to demonstrate flexibility and adaptability in a dynamic environment
• Experience working with and managing third party vendors, such as CROs
• 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 20% domestic and internationally
• The salary range for this position is commensurate with experience