Sr. Director, Clinical Operations

About the role

As the Sr. Director of Clinical Operations at Structuretx, you will play a pivotal role in shaping the future of clinical development within our organization. This leadership position requires a strategic thinker with a proven track record in clinical operations, who can effectively manage and oversee clinical trials from inception to completion. You will collaborate with cross-functional teams to ensure that our clinical programs are executed efficiently, adhering to regulatory standards and timelines. Your expertise will be crucial in driving operational excellence and fostering a culture of innovation within the clinical operations team.

Key facts

What you'll do

• Lead the planning, execution, and management of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
• Develop and implement clinical operations strategies that align with the overall goals of Structuretx, enhancing the efficiency and effectiveness of clinical programs.
• Collaborate closely with clinical development, regulatory affairs, and data management teams to ensure seamless integration of clinical operations with other functions.
• Oversee the selection and management of clinical research sites, ensuring they are equipped and prepared to conduct trials in compliance with GCP and ICH guidelines.
• Establish and maintain relationships with key opinion leaders, investigators, and external partners to facilitate successful trial execution and data collection.
• Monitor trial progress and performance metrics, identifying risks and implementing corrective actions as necessary to maintain project timelines.
• Lead and mentor a team of clinical operations professionals, fostering a collaborative environment that encourages professional growth and development.
• Ensure that all clinical documentation is accurate, complete, and submitted in a timely manner, supporting regulatory submissions and audits.
• Stay abreast of industry trends and regulatory changes, integrating this knowledge into clinical operations practices to maintain compliance and competitive advantage.
• Prepare and present updates on clinical operations to executive leadership and stakeholders, highlighting progress, challenges, and strategic initiatives.
• Drive process improvements within the clinical operations function, utilizing data and feedback to enhance operational efficiency and quality.
• Participate in the development of budgets and resource allocation for clinical trials, ensuring optimal use of resources to achieve project goals.

Requirements

• A minimum of 10 years of experience in clinical operations within the biopharmaceutical industry, with at least 5 years in a leadership role.
• Proven experience managing complex clinical trials, including Phase I-IV studies, with a strong understanding of GCP and regulatory requirements.
• Exceptional leadership skills with a demonstrated ability to build and manage high-performing teams.
• Strong project management skills, with a track record of delivering projects on time and within budget.
• Excellent communication and interpersonal skills, capable of effectively collaborating with diverse teams and stakeholders.
• Experience with electronic data capture systems and clinical trial management systems.
• A degree in life sciences, nursing, or a related field; advanced degree (MS, PhD, or MBA) preferred.

Nice to have

• Experience in rare disease or oncology clinical trials is a plus.
• Familiarity with global clinical trial regulations and international study management.
• Previous experience in a start-up or fast-paced environment, demonstrating adaptability and innovation.

Skills & tools

• Proficient in project management software and tools.
• Strong analytical skills with the ability to interpret complex data and make data-driven decisions.
• Knowledge of budget management and financial oversight in clinical trials.
• Familiarity with regulatory submissions and interactions with health authorities.
• Competence in using Microsoft Office Suite, particularly Excel and PowerPoint for reporting and presentations.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel to clinical sites and conferences.
• The role may involve working extended hours to meet project deadlines and accommodate global team collaboration.
• Structuretx is committed to fostering a diverse and inclusive workplace; we encourage applications from individuals of all backgrounds.

If you are a strategic leader with a passion for advancing clinical research and improving patient outcomes, we invite you to apply for the Sr. Director, Clinical Operations position at Structuretx. Join us in our mission to innovate and transform the landscape of clinical development.