Associate Director, CMC Project Management

ORIC Pharmaceuticals•South San Francisco, CA

2d•Onsite

About The Position

This role requires a leader with strong business acumen to define and execute business processes that drive complex programs through global registration and commercialization. This role will play a pivotal part in bringing innovative therapies to patients by ensuring that CMC development, manufacturing, and commercialization are executed with excellence, speed, and financial discipline. This individual will also oversee project management including timelines, budgets, invoices, reports and documentation, and may assist with regulatory filings. This position reports to the Chief Technical Officer.

Requirements

Advanced degree (PhD, MS, or equivalent) in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related field preferred.
9+ years of experience in biopharma CMC development, with increasing leadership responsibility.
Demonstrated success leading programs through commercialization including NDA filing and launch.
Deep expertise in CMC development, manufacturing, and regulatory requirements.
Proven ability to lead highly cross-functional, matrixed teams.
Strong track record of budget ownership and financial decision-making.
Extensive experience managing CMOs/CDMOs at a strategic level, including performance governance.
Ability to balance technical rigor with business and commercial considerations.
Exceptional communication, influence, and leadership skills.

Nice To Haves

Strategic thinker with strong execution discipline
Comfortable navigating ambiguity and complexity
Data-driven, with strong business and financial acumen
Collaborative, but decisive and accountable
High ownership mindset with a focus on outcomes

Responsibilities

Create and execute against integrated cross-functional project plans, leading the integrated CMC strategy.
Translate program strategy into cohesive development, manufacturing, and supply plans with clear milestones and deliverables.
Drive cross-functional alignment in close partnership with Clinical Development, Regulatory Affairs, Quality, Supply Chain, Commercial, and Finance teams.
Guide and lead project performance, risk and financial management, and issues resolution for functional groups.
Provide direction on requirements to meet internal and external stakeholders’ expectations.
Ensure CMC activities are executed in lockstep with clinical timelines, regulatory milestones, and commercial launch plans.
Serve as the CMC representative on program governance teams, influencing key decisions and trade-offs across functions.
Develop and manage comprehensive CMC budgets, including development, manufacturing, and supply chain costs.
Drive financial planning, forecasting, and scenario modeling to support program and portfolio decisions.
Identify and implement cost optimization strategies without compromising quality, timelines, or regulatory compliance.
Partner with Finance to ensure transparency, accountability, and disciplined capital allocation.
Evaluate investment trade-offs and provide data-driven recommendations to senior leadership.
Define 3y spending plans and hold quarterly financial updates.
Execute a robust external manufacturing strategy, including selection, onboarding, and management of CMOs/CDMOs.
Establish CDMO governance systems in conjunction with QA leadership such as performance metrics, and KPIs.
Ensure accountability for delivery, quality, cost, and timelines.
Proactively identify and mitigate risks across the external network, including capacity, quality, and supply continuity risks.
Drive strong, collaborative partnerships while maintaining rigorous oversight and escalation processes when needed.
Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and quality objectives.
Provide clear, concise communication and executive-level updates on risks, progress, and mitigation strategies.
Build alignment across stakeholders and drive decisive, forward-looking decision-making.