Associate Director, Clinical Study Management Millbrae, CA $180,000-$ 200,000 annually A rapidly growing oncology biotech in the Bay is redefining how complex diseases are addressed by combining advanced scientific thinking with modern engineering and operational rigor. The company is built around an innovative discovery platform that fuels a fast‑moving clinical pipeline and a culture that values curiosity, collaboration, and high‑quality execution. This role offers the opportunity to contribute to a science‑driven organization that is scaling quickly and committed to delivering meaningful new therapies to patients. The Associate Director, Clinical Study Management will lead the planning and execution of clinical trials across oncology and other therapeutic areas as needed. This individual will partner closely with cross‑functional Clinical Research & Development teams to ensure studies are delivered on time, within budget, and with uncompromising quality, supporting a culture of operational excellence and strong in‑house study leadership. This position requires a regular onsite presence‑at least three days per week‑in their Millbrea California office to enable effective study oversight, foster collaboration, and support a rapidly growing, high‑performing clinical operations organization. Key Responsibilities Lead and mentor Clinical Study Management staff, fostering a high‑performing team environment. Oversee study timelines, budgets, and deliverables in alignment with Clinical Development and Operational Plans. Work with limited oversight, partnering closely with Clinical Operations, Clinical Development, and cross‑functional study teams. Utilize broad therapeutic and clinical development expertise to inform study design and program‑level decisions. Provide direction to study teams to ensure operational excellence and adherence to protocols, ICH‑GCP, FDA, EMA, PMDA, and other relevant regulations and quality standards. Drive proactive risk assessment, mitigation planning, and continuous oversight to ensure patient safety and data integrity. Implement systems and processes that support inspection readiness throughout the study lifecycle. Oversee development and maintenance of detailed project timelines. Qualifications Bachelor's degree with 10+ years of relevant clinical operations experience, or 8+ years with an advanced degree. Demonstrated success leading large, global clinical trials , on an insource model. Comprehensive knowledge of ICH‑GCP , EMA requirements, and additional global regulatory guidelines. Proven track record managing timelines, budgets, and complex operational workflows. Strong leadership capabilities and excellent communication skills. Experience managing headcount, budgets, process optimization, and study delivery outcomes. High degree of accountability, urgency, and ability to work independently. Growth mindset and a commitment to collaborative problem‑solving. Employees enjoy a comprehensive benefits package that includes: 401(k) with company match Highly subsidized medical, dental, and vision coverage Mental health and wellness benefits Generous PTO and paid holidays, including week‑long summer and winter shutdowns Company‑paid life and AD&D insurance, with optional supplemental coverage Enhanced parental leave Daily subsidized lunch for onsite employees #J-18808-Ljbffr