Clinical Research, Director, Clinical Research, Study Operations
Behavioral Health Market Context
Apply Nowvia Jobilize
Benefits
Health InsurancePaid Time Off
Job Description
nnually + 10 Paid Holidays
401K with 100% Company Match up to 6%
3 Health Care Plan Options + Company HSA Contribution
Company Stock Grant Upon Hire
A DAY IN THE LIFE OF A Director, Clinical Research, Study Operations
The Director provides leadership, oversight, and direction to Associate Directors, Project Managers, and clinical research staff to ensure high-quality execution of clinical studies, audit readiness, and alignment with R&D timelines and corporate goals.
This role partners cross-functionally with R&D, Program Management, Study Development, Quality & Compliance, Medical Affairs, Marketing, Managed Care, and external sites to accelerate study start-up, optimize enrollment, and maintain regulatory compliance.
The Director oversees a portfolio of clinical studies, forecasts resource and portfolio needs based on a 1-3 year roadmap, and drives long-range planning, process innovation, and operational excellence.
Key responsibilities include establishing standards for site start-up, ensuring compliance with GCP and quality frameworks, partnering on continuous improvement initiatives, supervising Associate Directors, and ensuring high-quality data delivery to support analyses, publications, regulatory submissions, and broader evidence needs.
REQUIREMENTS
Advanced degree, required.
8 years of successful experience in the healthcare or clinical research field with progressive leadership responsibilities.
Proven track record of managing multi-study portfolios across multiple therapeutic areas or modalities.
Expertise in GCP, regulatory requirements, quality systems, and FDA expectations.
Strong organizational leadership, communication, and cross functional collaboration skills.
SCHEDULE
Monday-Friday, 40 hours/week, exempt position, working from the Friendswood, TX, Pittsburgh, PA or Phoenix, AZ office location.
READY TO JOIN OUR BIOTECH TEAM?
We truly appreciate your time.
If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application.
We're excited to learn more about you and look forward to connecting soon!
WORK AUTHORIZATION
All candidates must be legally authorized to work in the United States.
Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.
ABOUT CASTLE BIOSCIENCES INC.
At Castle, it all comes down to people.
After all, disease doesn't just happen - it happens to people.
We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests.
We are committed to empowering healthcare providers and patients with the goal of improved outcomes.
Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding.
We behave with integrity and treat our colleagues with respect and kindness.
Our culture fosters an environment of trust, transparency, and collaboration.
We prioritize and encourage internal growth and professional development.
Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ***.
This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online.
Only messages left for this purpose will be returned.
Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
• No third-party recruiters, please
401K with 100% Company Match up to 6%
3 Health Care Plan Options + Company HSA Contribution
Company Stock Grant Upon Hire
A DAY IN THE LIFE OF A Director, Clinical Research, Study Operations
The Director provides leadership, oversight, and direction to Associate Directors, Project Managers, and clinical research staff to ensure high-quality execution of clinical studies, audit readiness, and alignment with R&D timelines and corporate goals.
This role partners cross-functionally with R&D, Program Management, Study Development, Quality & Compliance, Medical Affairs, Marketing, Managed Care, and external sites to accelerate study start-up, optimize enrollment, and maintain regulatory compliance.
The Director oversees a portfolio of clinical studies, forecasts resource and portfolio needs based on a 1-3 year roadmap, and drives long-range planning, process innovation, and operational excellence.
Key responsibilities include establishing standards for site start-up, ensuring compliance with GCP and quality frameworks, partnering on continuous improvement initiatives, supervising Associate Directors, and ensuring high-quality data delivery to support analyses, publications, regulatory submissions, and broader evidence needs.
REQUIREMENTS
Advanced degree, required.
8 years of successful experience in the healthcare or clinical research field with progressive leadership responsibilities.
Proven track record of managing multi-study portfolios across multiple therapeutic areas or modalities.
Expertise in GCP, regulatory requirements, quality systems, and FDA expectations.
Strong organizational leadership, communication, and cross functional collaboration skills.
SCHEDULE
Monday-Friday, 40 hours/week, exempt position, working from the Friendswood, TX, Pittsburgh, PA or Phoenix, AZ office location.
READY TO JOIN OUR BIOTECH TEAM?
We truly appreciate your time.
If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application.
We're excited to learn more about you and look forward to connecting soon!
WORK AUTHORIZATION
All candidates must be legally authorized to work in the United States.
Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.
ABOUT CASTLE BIOSCIENCES INC.
At Castle, it all comes down to people.
After all, disease doesn't just happen - it happens to people.
We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests.
We are committed to empowering healthcare providers and patients with the goal of improved outcomes.
Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding.
We behave with integrity and treat our colleagues with respect and kindness.
Our culture fosters an environment of trust, transparency, and collaboration.
We prioritize and encourage internal growth and professional development.
Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ***.
This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online.
Only messages left for this purpose will be returned.
Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
• No third-party recruiters, please
Qualifications
- •Advanced degree, required
- •8 years of successful experience in the healthcare or clinical research field with progressive leadership responsibilities
- •Proven track record of managing multi-study portfolios across multiple therapeutic areas or modalities
- •Expertise in GCP, regulatory requirements, quality systems, and FDA expectations
- •Strong organizational leadership, communication, and cross functional collaboration skills
- •All candidates must be legally authorized to work in the United States
Benefits
- •Excellent Annual Salary + 35% Bonus Potential
- •20 Accrued PTO Days Annually + 10 Paid Holidays
- •401K with 100% Company Match up to 6%
- •3 Health Care Plan Options + Company HSA Contribution
Responsibilities
- •A DAY IN THE LIFE OF A Director, Clinical Research, Study Operations
- •The Director provides leadership, oversight, and direction to Associate Directors, Project Managers, and clinical research staff to ensure high-quality execution of clinical studies, audit readiness, and alignment with R&D timelines and corporate goals
- •This role partners cross-functionally with R&D, Program Management, Study Development, Quality & Compliance, Medical Affairs, Marketing, Managed Care, and external sites to accelerate study start-up, optimize enrollment, and maintain regulatory compliance
- •The Director oversees a portfolio of clinical studies, forecasts resource and portfolio needs based on a 1-3 year roadmap, and drives long-range planning, process innovation, and operational excellence
- •Key responsibilities include establishing standards for site start-up, ensuring compliance with GCP and quality frameworks, partnering on continuous improvement initiatives, supervising Associate Directors, and ensuring high-quality data delivery to support analyses, publications, regulatory submissions, and broader evidence needs
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