Director, CMC Project Management (Onsite in SSF - 3X/WK)

The Director, CMC Project Management is a key development role in the CMC and Technical Operations organization. This position partners closely with Quality, Clinical Operations, Regulatory Affairs, Global Program and Project Management, Finance, Preclinical, and Business Development. This role supports all CMC development functions – including Drug Substance, Drug Product Development, Analytical Development – as well as manufacturing and supply chain in support of all Pliant development programs. This position is part of the CMC Technical Operations leadership team and reports to the Chief Technical Officer.  

• Leads the CMC core team meetings under the mentorship of the Technical Project Lead and drives team to meet project deliverables on time and within budget.
• Leads long-range planning (LRP) and budget activities in partnership with the CTO.
• Partners with function heads to develop and monitor project timelines, budget, and associated tracking tools.
• Raises awareness about the criticality of CMC activities to overall project success. Executes scenario planning, risk assessments, action logs as appropriate.
• Manages CMC sub-team, and Contract Organization standing meetings, including agendas, minutes, and action items. Coordinate business review meetings with all key vendors.
• Support the development of CMC strategies to meet business objectives for Pliant’s development projects, registration, NDA-readiness, and commercial launch.
• Drives timely decisions and accountability within teams while facilitating active communication and information flow between peers, team members, stakeholder functions, and governance bodies. Escalate critical issues to appropriate stakeholders and governance bodies.
• Establish and follow project management best practices including management of scope, requirements, risks, and long-range planning.
• Contributes to CMC portfolio analysis to drive decision making and resource allocation/budgeting across functions.
• Consults with project sponsors and stakeholders at all levels to determine goals, timelines, funding, resources, and procedures for accomplishing projects; Assess impact of project scope changes to CMC activities and manufacturing plans.
• Establish and maintain positive relationships with stakeholders and team members.

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

• BS/MS degree in Science, Engineering or a related field.
• Minimum of 12 years of project management-related experience as either a designated project manager or PM responsibilities as part of a technical role, preferably in a small/medium sized biotech setting. Prior experience as a technical lead a plus.
• Small molecule solid oral experience preferred.
• Knowledge, understanding and direct application of project management best practices and proficiency with supporting project management tools; PMP certification a plus.
• Knowledge of biotechnology/pharmaceutical product development: process development, analytical development, manufacturing, clinical supply chain, CMC regulatory filings, GMP manufacturing process. Working understanding of regulatory and clinical project management is also a plus.
• Strong time management, planning, and organizational skills.
• Demonstrated ability to prioritize and balance multiple competing tasks, plan realistic deadlines, and drive to completion.
• Strong communication, leadership, and cross-functional collaboration skills.
• Ability to thrive in a fluid environment, quickly adapting to new situations.

How you work

• Dare to Succeed: Approach regulatory strategy with courage and creativity, challenging convention when it advances patient outcomes. Take ownership of ambitious goals and navigate early‑development ambiguity with resilience and sound judgment.
• Make an Impact: Operate with urgency and focus, prioritizing high‑value actions that drive programs forward. Elevate regulatory quality and efficiency by anticipating obstacles and building scalable, best‑in‑class processes.
• One Pliant: Collaborate seamlessly across functions, building trust and alignment with internal and external partners.

The annual base salary for this role is $248,000 – $274,000 Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.