Vice President, Clinical Development Program Lead

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 Head of Clinical Development, the Vice President, Clinical Development Program 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

Requirements

• Requires a Medical Degree; U.S. licensure and Board Certification in a relevant therapeutic area are strongly preferred
• A minimum of 15+ years’ experience across all phases of therapeutic development for multiple indications, in a bio-pharmaceutical/pharmaceutical company (minimum 10 years), medical monitoring within a global CRO, and/or clinical practice in a relevant therapeutic area.
• Proven success record in the design and execution of clinical development strategies, as well as the successful submission of IND’s
• Experience leading and oversight of medical monitoring activities
• Thorough knowledge of FDA regulatory requirements, clinical research concepts & practices, and ICH/GCP guidelines and global regulatory requirements
• 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