Associate Director/Senior Project Manager, CMC

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 Director, Program Management, the Associate Director/Senior Project Manager, CMC will have proven experience in preclinical through all phases of clinical development project management. As a key member of designated program teams, the CMC Project Manager will work collaboratively with cross-functional team leaders and the program team to drive the definition of our CMC strategy and provide team support through all product development stages.

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):

• Manage the deliverables, scope, timelines, resources on CMC project activities for designated programs. Identify and analyze project risks and help guide team to develop appropriate mitigation strategies
• Lead the translation of strategy into integrated CMC timelines and deliverables across projects and communicate the plan to all key stakeholders
• Conduct critical path analyses and pro-actively identify resource constraints/bottlenecks; continually work with the program team to review and address issues
• Support the CMC leaders by organizing, scheduling, and facilitating CMC team meetings to review CMC Plans, CMC risks, CMC deliverables, and minute actions
• Ensure functional area “buy-in”, Product Development Team (PDT), and management approval for each CMC Plan and all updates
• Develop and provide consistent project reporting to the CMC and Project Teams and CMC Project status reporting to Senior Management

Qualifications

• Requires a Bachelor’s degree in a relevant technical discipline and a minimum 8 years of relevant industry experience, including a minimum of 4 years CMC project management
• Advanced degree and/or PMI or PMP certification desired
• Must have experience in project management techniques and principles including: project planning, execution and tracking, risk identification, resource and financial project planning
• Comprehensive understanding of the CMC development strategies across all phases of development and commercialization
• Experience with combination products and device development
• Strong technical/analytical skills to identify and solve problems in a fast-paced environment
• Experience in preparation and submission of regulatory documents in support of regulatory filings
• Excellent oral and written communication skills
• Strong organizational skills to maintain a high level of productivity, innovation, and setting priorities in order to complete assignments in a timely manner and within budget
• Exhibits high initiative, strong drive, and follow-through
• High level of commitment, flexibility and strong planning, coordination, teamwork, communication and interpersonal skills
• Extensive intermediate to advanced computer skills (Microsoft Project, Microsoft Excel, Microsoft PowerPoint, and SmartSheet)
• Strong commitment to ethical standards
• Ability to travel p to 5-10%
• 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 coverage with 100% of premiums paid by Viridian for 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.