Sr. Medical Director/Executive Medical Director, Clinical Development Lead

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/Executive Medical Director, 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 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 Qualifications Requires a Medical Degree; 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 10 years), medical monitoring within a global CRO, and/or clinical practice in a relevant therapeutic area, ophthalmology preferred. 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 environment Experience working with and managing third party vendors, such as CRO’s. 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 Benefits Competitive pay and stock options for all employees Medical, dental, and vision coverage for Viridian employees and their eligible dependents Fertility and mental health programs 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 mental, financial, and proactive physical health programs covered by Viridian 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. #J-18808-Ljbffr