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.
