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Job description
At Viridian, 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 Chief Medical Officer, the SVP of Clinical Development, FcRn/immunology will serve as one of two senior Clinical Development leaders and will have primary accountability for the clinical development strategy and execution for assigned programs within Viridian’s portfolio. This leader will provide medical and scientific leadership by leading the clinical development team and trial activities across development planning: study design, protocol execution, data interpretation, regulatory strategy, and external scientific engagement in investigator meetings and key external medical relationships.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
Serve as one of two senior Clinical Development leaders reporting to the CMO, with primary accountability for assigned FcRn/immunology programs
Provide strategic insights into disease area and clinical trial strategies for from IND through registrational development, regulatory submission, approval, and lifecycle management, as applicable
Lead the development of integrated clinical development plans, study concepts, synopses, protocols, and clinical sections of regulatory documents/CSRs
Oversee the review, analysis and interpretation of clinical trial data and the reporting of clinical trial results, including preparation of abstracts, presentations, and manuscripts
Partner with the peer SVP, Clinical Development to ensure consistent quality, medical rigor, inspection readiness, and cross-program learning across the portfolio
Collaborate closely with functional leaders in Program Leadership, Clinical Operations, Data Management, Global Safety/ Pharmacovigilance, Biometric Sciences and Regulatory Affairs to support clinical and program teams in the design, planning, execution and reporting of clinical plans and studies
Partner with cross functional leaders and provide Clinical Development support for initiatives/activities led by Research/Non-clinical teams, Competitive Intelligence teams, Medical Affairs and Business Development
Build, lead and mentor a team of Clinical Development Leads and Clinical Development Scientists in providing Scientific and Medical expertise for all assigned FcRn/immunology programs including development of core clinical documents (eg, study synopses, protocols, CSRs)
Oversee and provide Clinical Development expertise in preparation of clinical components of regulatory submissions (INDs, BLAs, Global Regulatory interactions and other regulatory submissions); prepare for and participate in meetings with FDA/EMA/PMDA
Provide medical and scientific leadership for study execution in partnership with Clinical Operations, including protocol implementation, site/investigator engagement, medical monitoring strategy, data review, issue escalation, and interpretation of emerging clinical data
Stay current and ensure adherence with GCP and worldwide regulatory requirements
Manage Clinical Development resources, budget, and expenses
Supervisory responsibilities include performance management, hiring and career development
Qualifications:
Requires an MD degree with 20+ years’ relevant experience in clinical development, clinical research, and/or the practice of medicine, including at least 5 years leading clinical development programs or organizations within the biopharmaceutical or pharmaceutical industry.
Extensive clinical development experience across all phases of therapeutic development for multiple indications – experience in immunology/autoimmune preferred
Prior leadership of late-stage or registrational clinical development programs strongly preferred
Demonstrated ability to operate as an enterprise leader, balancing portfolio priorities, organizational needs, talent development, and cross-functional alignment
Experience presenting clinical strategy, data interpretation, risks, and recommendations to executive leadership, board-level audiences, and external stakeholders
Proven success record in the design and execution of clinical development strategies, as well as the successful submission of IND’s, NDAs/BLAs
Experience in regulatory interactions (eg, pre-IND, EOP2, Type C, EMA Scientific Advice) and knowledge of drug safety and pharmacovigilance activities
Thorough knowledge of 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 CRO’s
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel up to 25%
The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
Competitive pay and stock options for all employees
Medical, dental, and vision insurance
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
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.
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Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.