Senior Director CMC Project Management

Ardelyx•Waltham, MA

52d•Hybrid

About The Position

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. The Senior Director, CMC Project Management is responsible for leading and coordinating the strategic planning, integration, and execution of the company’s CMC development programs across the portfolio. This role serves as the central program leadership function within Technical Operations and Quality Assurance, driving cross-functional alignment, integrated planning, and disciplined execution from early development through clinical and commercial milestones. Reporting to the Chief Technical Operations & Quality Officer, this individual will partner closely with Technical Operations, Regulatory, Quality, Clinical, and Finance to ensure CMC programs are delivered on time, within scope, and aligned with corporate objectives. This role is best suited for a strong program leader with deep experience in CMC project management, governance, and cross-function team leadership in a matrixed biotech environment.

Requirements

Bachelor’s degree, advanced degree preferred, in Chemistry, Chemical Engineering, or related field
12+ years of experience in pharmaceutical or biotech industry, with at least 3 years in CMC project management or related technical operations role or equivalent experience
Strong understanding of drug substance and drug product development, technology transfer, and GMP manufacturing
Small molecule and solid oral dosage form experience preferred.
Experience managing external partners (CMOs/CDMOs)
Working knowledge of regulatory CMC requirements (FDA, ICH)
Decision Making – has a systematic and methodical approach to making decisions, obtains relevant information, thinks beyond the immediate decision point, challenges assumptions and considers business implications of potential solutions
People Leadership - Ability to lead and influence effectively
Strong analytical, problem-solving, and planning skills
Exceptional organizational and communication skills with the ability to work independently and collaboratively across all levels of the organization
Positive Change Agent – curious, adaptable, and energizing leader with a global mindset
Culture Ambassador - champions and models the organization’s values, fostering a culture of quality, inclusion, and continuous improvement across all teams
Proficiency with project management tools (Smartsheet strongly preferred)
Strong problem-solving, critical thinking, and risk management skills
Ability to thrive in a fast-paced, dynamic environment with shifting priorities

Nice To Haves

Small molecule and solid oral dosage form experience preferred.

Responsibilities

Lead and manage a portfolio of strategic CMC projects, ensuring alignment with enterprise priorities
Define clear strategic priorities, project milestones, performance standards and expectations across a matrixed, cross-functional team of key stakeholders
Act as a trusted liaison between executive leadership and project teams, translating strategic goals into actionable plans
Ensure consistent application of project management best practices, including integrated project plans, timelines, risk registers, and governance
Review and challenge project strategies, critical paths, and risk mitigation plans; escalate issues and trade-offs as needed
Drive effective transition of projects from Research into Technical Operations and onward to commercial manufacture
Partner cross-functionally with Manufacturing, Analytical Development, Quality, Regulatory, External Supply, Procurement, Finance, Clinical, and Commercial stakeholders
Partner with CDMOs and external vendors to ensure aligned execution, transparent communication, and risk management
Enable proactive portfolio visibility through integrated project plans, scenario planning, and resource forecasting
Identify, Establish and continuously improve project management processes, tools, metrics, and operating models across Technical Operations to improve efficiency
Identify capability gaps, capacity constraints, and opportunities for operational excellence
Drive adoption of standardized tools and frameworks for program tracking and reporting
Champion a culture of inclusion, continuous improvement and operational excellence
Support development and accountability to budget and other financial planning deliverables across the function
Optimize resource utilization and monitor KPIs to assess program health and impact
Prepare executive-level dashboards or MS PowerPoint milestone timelines to communicate progress and escalate risks
Serve as communications conduit to external partners and internal cross-functional project teams, including executing project tasks and details
Coordinate and document agenda and meeting notes to ensure smooth execution of functional activities and extended leadership meetings