Associate Director, CMC Project Management
$210k - $260kORIC Pharmaceuticals, Inc.
Associate Director, CMC Project Management Full-time Department: Supply Chain & Program Mgmt 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. 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 and is responsible for the following: 1. End-to-End CMC Leadership & Cross-Functional Integration 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. 2. Budget Planning & Financial Stewardship 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. 3. Strategic CMO/CDMO Oversight & External Partnerships Working with functional leads (Drug Substance, Drug Product, and Analytical Department Heads), 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. Education & Experience 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. Leadership Profile 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 The anticipated salary range for Associate Director level candidates who will work on-site at our South San Francisco location is between $210,000-$260,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. 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. #J-18808-Ljbffr ORIC Pharmaceuticals, Inc.
$210k - $240k
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Structure Therapeutics in South San Francisco is seeking a Director Technical (CMC) Project Management to lead CMC project management for late-stage development programs through commercialization. The ideal candidate will have 12+ years of experience in pharma or biotech...- Structure Therapeutics in South San Francisco is seeking a Director Technical (CMC) Project Management to lead CMC project management for late-stage development programs. The successful candidate will drive integrated project planning, execution, and lifecycle management...
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...Associate Director, Drug Substance Manufacturing – Upstream ProcessBrisbane, CA... ...technology transfer, life cycle management, and global regulatory submissions... ...therapeutics.Working with the CMC team and other key functions such as project management, QA and Regulatory,...Flexible hours- ...three days per week on average. Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing,... ...risk identification, and proactive planning Develop and manage a clinical trial public disclosure tracker and lead...Work at officeLocal areaRemote workNight shift3 days per week
$175k - $210k
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$186k - $235k
...geographic location. Position Summary The Associate Director of Medical Writing will be... ...writing professional with the ability to manage multiple projects in a fast‑paced environment. The ideal... ...Biostatistics, Pharmacovigilance, Nonclinical, CMC, and Program Management) to gather...Remote work$200k - $220k
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...the kidney. Position Summary The Associate Director, Drug Substance Manufacturing -... ...transfer, life cycle management, and global regulatory submissions... ...therapeutics. Working with the CMC team and other key functions such as project management, QA and Regulatory,...For contractorsFlexible hours- ...execution of partnered and internal research programs from discovery through early development. You will develop integrated plans, manage milestones, risks, and dependencies, and coordinate with cross-functional teams in a fast-paced environment. The role is based in San...Work at office
$166k - $195k
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