Director, Technical (CMC) Project Management

Structure Therapeutics develops lifechanging medicines for patients using advanced structurebased and computational drug discovery technology. The companys platform combines the latest advancements in visualization of molecular interactions computational chemistry and data integration to design orally available superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinicalstage pipeline of differentiated treatments focused on chronic diseases with high unmet need including cardiovascular metabolic and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Position Summary:

Reporting to SVP Technical Operations the Director Technical (CMC) Project Management will provide technical CMC project management support and leadership across all late-stage development programs through commercialization and lifecycle management. This role is responsible for driving integrated project planning execution budget planning risk management cross-functional alignment and meeting facilitation support for the Tech Ops leadership and CMC Teams.

The successful candidate is a seasoned technically savvy project management expert that will serve as a member of the Technical Operations leadership team and be responsible for establishing best in class project management practices tools and discipline within Tech Ops as well as representing the department in various companywide cross-functional team forums.

Job Responsibilities:

Strategic CMC Project Leadership

• Lead end-to-end CMC project management for late-stage development programs through commercial launch and lifecycle management.
• Develop and maintain integrated cross-functional project plans covering drug substance drug product analytical quality regulatory and supply chain activities.
• Ensure alignment of project execution with overall program strategy timelines and business objectives.
• Serve as a key member of the Technical Operations leadership team.

Project Planning Tracking and Execution

• Develop and manage detailed project plans (Gantt-based) including timelines milestones dependencies and critical paths.
• Track execution of activities across internal teams and CDMO partners across multiple time zones.
• Monitor progress against timelines budgets and deliverables; proactively identify and resolve risks and issues.
• Drive accountability for action items deliverables and project milestones.

Team Facilitation and Meeting Management

• Facilitate weekly CMC team meetings and other governance forums.
• Develop proactive agendas and prepare supporting materials to drive effective decision-making.
• Establish and enforce best practices for meeting management communication and cross-functional information flow.
• Ensure clear documentation of decisions actions and follow-ups.

Budgeting Financial Tracking & Reporting

• Partner with Tech Ops department heads to develop project and multi-year departmental budgets.
• Collaborate with Finance and CDMOs to track spending accruals and budget performance.
• Ensure alignment between project plans work orders and financial forecasts.
• Provide regular financial and project status reporting to leadership.

Cross-Functional & External Coordination

• Interface with Tech Ops functional leads including External Manufacturing Process Development Analytical Quality Regulatory CMC and Supply Chain.
• Support department heads and working teams coordinate project activities across a network of global CDMOs.
• Partner with Procurement and Legal to ensure timely execution of work orders contracts and budget approvals.
• Interface with company-wide program teams and project managers to ensure consistent reporting of dashboards progress and risks.

Risk Management & Continuous Improvement

• Develop and maintain project risk registers and mitigation strategies.
• Proactively manage project risks related to timelines cost quality and supply.
• Identify and drive continuous improvement opportunities including timeline acceleration cost optimization and risk reduction.
• Ensure lessons learned are captured and implemented across programs.

Project Management Excellence

• Establish best-in-class project management standards tools and processes within Technical Operations.
• Drive a culture of collaboration accountability innovation and execution excellence.
• Serve as both a strategic leader and hands-on contributor in a growing organization.
• Mentor and develop project management capabilities across the organization.

Qualifications:

• B.S. in Chemistry Engineering or related discipline required; advanced degree (M.S. or Ph.D.) and accreditation in Project Management preferred.
• 12 years of progressive experience in pharmaceutical or biotech CMC functions including one or more of the following: manufacturing process development analytical quality supply chain or regulatory CMC.
• At least 5 years of experience in project management supporting late-stage development through commercial launch.
• Direct experience with small molecule and oral solid dosage (OSD) products.
• Demonstrated experience supporting commercialization and lifecycle management activities.
• Strong understanding of CMC development manufacturing regulatory and supply processes and requirements.
• Expertise in project management tools (e.g. MS Project Smartsheet Excel PowerPoint).
• Strong experience developing and managing detailed project plans and timelines.
• Good understanding of financial planning budgeting and accrual tracking processes.
• Proven ability to operate effectively in a fast-paced matrixed and global environment.
• Strong analytical problem-solving and decision-making capabilities.
• Ability to think strategically while maintaining attention to detail and execution.
• Excellent communication and cross-functional influence.

Travel Required: up to 25% globally

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role the anticipated base pay range is $209000-$260000. The exact base pay offered for this role will depend on various factors including but not limited to the candidates geography qualifications skills and experience.

At Structure base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus new hire equity and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings including but not limited to medical dental and vision insurance 401k match unlimited PTO and a number of paid holidays including winter shutdown.

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Required Experience:

Director