Sr. CTM/Associate Director Clinical Operations
San Francisco, CA (Hybrid)
We are partnered with an innovative biotech venture nestled in the heart of San Francisco, where innovation meets impact in the realm of oncology. We are on a relentless pursuit of redefining cancer treatment through the precision of Antibody Drug Conjugates. As we chart new territories in therapeutic breakthroughs, we're actively seeking an exceptional Sr. CTM/Associate Director of Clinical Operations to be a driving force in our revolutionary projects. You will be at the forefront of a company that's unraveling the mysteries of cancer by targeting notoriously resilient cells. With a commitment to ADC treatments, we're unlocking pathways to treat the toughest cases with unprecedented accuracy. Your role will be instrumental in orchestrating clinical trials that not only push the boundaries of science but redefine the future of cancer care.
- Clinical Trial Oversight: Lead and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements, while maintaining the highest standards of data quality and patient safety.
- Cross-Functional Collaboration: Foster seamless collaboration between diverse teams, including clinical development, regulatory affairs, data management, and medical affairs, to ensure effective communication and coordination throughout all stages of clinical operations.
- Strategic Planning: Contribute to the development and execution of strategic plans for clinical programs, providing valuable insights and recommendations to enhance trial design, patient recruitment strategies, and overall project success.
- Risk Management: Identify potential risks and challenges in clinical trial operations, developing proactive mitigation strategies to address issues promptly, ensuring the smooth progress of trials and the achievement of key milestones.
- Vendor Management: Collaborate with external vendors, including clinical research organizations (CROs) and other service providers, to optimize resources, budgets, and timelines, while maintaining strong partnerships to achieve project goals.
- Regulatory Compliance: Stay abreast of evolving regulations and guidelines, ensuring that all clinical operations activities adhere to ethical, legal, and regulatory standards, and contribute to the preparation of regulatory submissions as needed.
- Continuous Improvement: Drive a culture of continuous improvement by assessing and implementing innovative approaches and technologies in clinical trial operations, striving for increased efficiency, data quality, and overall excellence in oncology research.
- Clinical Operations Expertise: A minimum of 8-10 years of hands-on experience in clinical operations within the biotech or pharmaceutical industry, demonstrating a comprehensive understanding of the end-to-end clinical trial process.
- Oncology Background: Strong background in oncology clinical trials, with a focus on precision medicine and a deep understanding of the challenges and nuances associated with targeting specific protein cells in cancer treatment.
- Leadership and Team Management: Proven ability to lead and inspire cross-functional teams, with a track record of successfully managing and mentoring clinical operations professionals. Demonstrated leadership in driving teams towards shared goals and objectives.
- Regulatory Compliance: In-depth knowledge of global regulatory requirements for clinical trials, with the ability to navigate and ensure compliance with regulatory standards. Experience in contributing to regulatory submissions and interactions with health authorities is highly desirable.
- Strategic Thinking: Strong strategic mindset with the ability to contribute to the development and execution of clinical development plans. Proven experience in providing strategic input to enhance trial design, patient recruitment, and overall clinical program success.
- Competitive Compensation
- Medical, Dental, Vision Insurance