Associate Director, CMC Project Management at ORIC Pharmaceuticals | CA, USA | Rezi

Associate Director, CMC Project Management at ORIC Pharmaceuticals

Associate Director, CMC Project Management

ORIC Pharmaceuticals · CA, USA

1 months ago

Associate Director, CMC Project Management

ORIC Pharmaceuticals · CA, USA

a month ago
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About the Role

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.

Responsibilities

  • Create and execute 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 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.
  • 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.
  • Oversee project management including timelines, budgets, invoices, reports and documentation.
  • May assist with regulatory filings.

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.
  • 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.

Skills

  • CMC development
  • Manufacturing
  • Regulatory requirements
  • Cross-functional team leadership
  • Budget ownership
  • Financial decision-making
  • CMO/CDMO management
  • Strategic thinking
  • Execution discipline
  • Navigating ambiguity
  • Data-driven analysis
  • Business acumen
  • Financial acumen
  • Collaboration
  • Decisiveness
  • Accountability
  • High ownership mindset
  • Communication
  • Influence
  • Leadership

Location

  • South San Francisco, California

Work Type

  • On-site

Experience Level

  • 9+ years of experience in biopharma CMC development, with increasing leadership responsibility.

Education Level

  • Advanced degree (PhD, MS, or equivalent) in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related field preferred.

Salary/Compensations

  • $210,000-$260,000

About the Company

  • ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer.
  • ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers.
  • Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms.
  • ORIC has offices in South San Francisco and San Diego, California.
  • For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.

Equal Opportunity

  • ORIC Pharmaceuticals, Inc. is an equal opportunity employer.
  • ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.