Jobs in Burlingame, CA

About the role

The Clinical Affairs Senior Manager/Associate Director will be responsible for the design, execution and monitoring of clinical studies and will provide scientific expertise throughout the development and implementation of the studies. This role is accountable for the end-to-end clinical strategy, design, execution, oversight, and reporting of clinical studies supporting product development, regulatory submissions, and commercialization. S/he will work closely with R&D, Regulatory Affairs, Quality and external stakeholders to ensure high-quality, compliant, and efficient clinical programs and interact with regulatory agencies as needed to support regulatory submissions and audits.

What you'll bring

• B.S. in Biomedical Engineering, Life Sciences or similar
• 7-10+ years of progressive experience in clinical research within the medical device industry, including leadership of complex clinical studies
• Demonstrated experience developing and executing clinical strategies that support regulatory submissions and product approvals.
• Strong working knowledge of Good Clinical Practice (GCP), FDA and international regulations, ISO standards and clinical research best practices
• Proven ability to lead cross-functional teams and influence without direct authority.
• Excellent written and verbal communication, skills including experience presenting to senior leadership and regulatory agencies
• High attention to detail and accuracy
• Fluent in medical terminology and sound knowledge of anatomy
• Strong analytical, problem-solving, and decision-making skills with high professional judgment.
• Ability to thrive in a fast-paced, evolving startup environment with a hands-on, ownership-oriented mindset
• Takes initiative and acts quickly to drive to solutions with a driven outlook and with a strong desire to succeed as a team player, and as a key part of a company
• Ability to travel up 20% domestically and internationally

Benefits