DescriptionReporting 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
Requirements- 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
- 100% Paid Parental Leave
- 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
