Head of Clinical Operations

Job Title: Head of Clinical Operations

Location: Seattle WA

Reports to: SVP Product Development Leader

About Us:

At Just-Evotec we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from each other and pushing the boundaries of whats possible. Were on a mission to create a place where curiosity isnt just encouraged its celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper#BeCureious with us and see where your curiosity can take you!

The Role:

Were looking for a passionate and curious Head of Clinical Operations to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As the Head of Clinical Operations at Just-Evotec youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

What Youll Do:

• Oversee the planning initiation and execution of early phase clinical trials
• Develop and manage study timelines budgets and resource allocation
• Ensure studies meet all regulatory requirements ethical guidelines and GCP standards. Drive communication with internal and external stakeholders/teams as well as senior management
• Monitor progress of clinical trials and ensure adherence to protocol
• Manage relationships with external vendors including CROs laboratories and other service providers
• Coordinate and manage Investigational Drug Product supplies packaging labeling and shipping both internally and externally
• Ensure clinical sites and investigators are adequately supported and perform as per protocol requirements
• Ensure that all clinical trial activities comply with ICH and FDA requirements
• Support regulatory submissions and audits by ensuring required documentation and data are available
• Perform site evaluations and visits to ensure compliance with trial protocol timelines and regulatory guidelines
• Work with Justs Regulatory and Compliance Teams to insure all requirements are met
• Ensure accurate timely and complete clinical trial data are recorded
• Monitor clinical data to ensure consistency accuracy and adherence to trial protocols
• Identify issues and risks and provide proactive solutions to mitigate trial delays or non-compliance
• Develop and manage trial budgets ensuring trials are completed on time and within financial parameters
• Monitor study expenditures and manage cost-effective trial conduct
• Review and approve invoices purchase orders and site payments
• Identify and address potential risks to the project timeline quality or budget and escalate when necessary
• Implement corrective and preventive actions to ensure successful trial delivery
• Ensure accurate and timely reporting of trial progress safety concerns and study outcomes to stakeholders
• Maintain up-to-date trial documentation including Investigator Brochures study protocols case report forms (CRFs) and clinical study reports (CSRs)

Who You Are:

• Bachelors degree in Life Sciences Nursing Pharmacy or related field (required). Advanced degree (Masters PhD) preferred
• At least 12 years of experience in clinical research clinical operations or related field
• Prior experience in managing early phase clinical trials is highly preferred
• Experience in managing cross-functional teams and liaising with external stakeholders (CROs clinical sites vendors)
• Clinical trial experience with monoclonal antibodies
• Familiarity with US government contract requirements
• Strong understanding of clinical trial processes GCP ICH guidelines and FDA regulations
• Excellent project management skills with the ability to manage multiple studies simultaneously
• Strong leadership and interpersonal skills with the ability to manage teams and stakeholders effectively
• Attention to detail and the ability to monitor analyze and interpret clinical data
• Excellent communication skills (verbal and written)

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life with hybrid work schedules in many of our various locations.
• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
• Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mind just like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.

Let your curiosity guide your career. #BeCurious and explore the endless possibilities at Just-Evotec!

The base pay range for this position at commencement of employment is expected to be $168000 to $210000; Base salary offered may vary depending on individuals skills experience and competitive market value.

Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision short-term and long-term disability company paid basic life insurance 401k company match flexible work generous paid time off and paid holiday wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.