Associate Director - Clinical Study Management
Associate Director, Clinical Study Management
Millbrae, CA
$180,000-$ 200,000 annually
(Onsite 3 days per week)
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.
Benefits
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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.