Director, CMC Project Management

Role Summary

As the Director, CMC Program Management (CMC PM), you will be responsible for facilitating CMC planning and cross-functional alignment for our drug development programs to enable successful execution. This role will require attention to detail, proficiency in forward planning and organizational skills and effective stakeholder management. This position will report to the Executive Director of CMC.

Responsibilities

• In collaboration with the CMC team members, facilitate management of the CMC activities for our drug development programs, ensuring they are completed on time, within budget, and according to company goals
• Work closely with CMC quality assurance and CMC regulatory to ensure effective collaboration and execution of CMC deliverables
• Maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs
• Collaborate with cross-functional program managers to effectively communicate CMC activities and ensure alignment with overall program goals and timelines
• Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success
• Manage relationships with external partners, vendors, and contractors as required to ensure smooth program execution
• Support development and refinement of processes, tools and systems to deliver high quality PM support to the CMC programs

Qualifications

• Bachelor's degree in a related field required; advanced degree preferred
• 15+ years of experience in CMC program management within the biotech or pharmaceutical industry
• PMP certification preferred
• Strong experience in providing program management to CMC teams while interacting with cross-functional teams
• Knowledge and understanding of CMC early-stage development pathways, including cell line development, drug substance and drug product manufacturing processes, analytical, formulation and stability studies
• Preferred knowledge and understanding of CMC late-stage development including process characterization, process and method validation, tech transfers and comparability studies. Additionally, experience in managing programs for combination products is also desired.
• Excellent organizational skills and ability to forward-plan
• Proven track record of successful project management of complex drug development programs in a fast-paced startup environment
• Expertise with project management tools (e.g. Smartsheet, Microsoft Timeline Pro+)
• Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment
• Proactively identifies issues and drives resolution; can anticipate key future events and adjust team priorities/plans accordingly
• Excellent communication and interpersonal skills with the ability to influence and motivate cross-functional teams, manage a diverse set of stakeholders, and work closely with team leaders
• Strong written and oral communication skills with strong attention to detail

Education

• Bachelor's degree in a related field required; advanced degree preferred

Additional Requirements

• This is a remote role; periodic travel to team and company events is required.