What are the responsibilities and job description for the Sr. Medical Director/Vice President, Clinical Development Lead position at Viridian Therapeutics, Inc?
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 Head of Clinical Development, the Senior Medical Director/Vice President, Clinical Development Lead will assist with establishing and leading the clinical development strategy for assigned Viridian assets from early-stage development through regulatory approval. The incumbent will perform various duties in support of all aspects of clinical development (science, medical, and operations), for assigned assets/clinical programs including the generation and review of key trial data-related documents (investigator brochure, protocol, clinical study reports), contributing to regulatory documents, leading the program and trial level clinical/medical strategy 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 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):
- Serve as the Clinical Development Program 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.
- Manage and mentor clinical development professionals on assigned clinical programs, including clinical scientists, and/or medical monitors. May serve as medical monitor on assigned trials and the Sponsor’s medical representative to multiple vendors and collaborators.
- Ensure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, safety/PV, data management, program management, and research colleagues.
- Ensure all clinical development activities comply with global regulatory requirements and Good Clinical Practice (GCP) guidelines.
- Develop and manage clinical development program budgets, ensuring cost-effective use of resources.
- Collaborate closely with Clinical Operations colleagues on clinical trial activities, specifically the management and oversight of global medical monitoring activities including oversight of CRO responsibilities and medical communications with clinical investigators
- Manage the overall medical review including trending in clinical trial data and coordinate these activities with engaged vendors
- Prepare clinical sections of regulatory documents (INDs, briefing documents for scientific advice, BLA); prepare for meetings with FDA/EMA
- Manage/participate in advisory boards, DSMBs/ safety committees in support of assigned programs/trials and relevant therapeutic area.
- Stay current with scientific literature, GCP and worldwide regulatory requirements
