Vice President, Clinical Operations

$330,000 - $370,000/Yr

Systimmune - Redmond, WA

Full-time - Senior

Redmond, WA

Chemical Manufacturing

About the position

Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. The Vice President of Clinical Operations will lead the strategic planning, execution, and management of all clinical trials at SystImmune, ensuring that they are conducted with the highest standards of quality and compliance. This role will involve overseeing clinical operations across the US, EU, and other global regions, focusing on building a world-class in-house clinical operations team. Essential Duties and Responsibilities include developing and implementing the clinical operations strategy to align with SystImmune's goals and objectives, overseeing the design, initiation, execution, and completion of clinical trials, and ensuring alignment with regulatory requirements, budgets, and company standards. The VP will foster a culture of excellence, innovation, and collaboration within the clinical operations team, lead and manage the global clinical operations team (ex-China), and ensure the efficient and timely conduct of clinical trials, including site selection, patient recruitment, data management, and monitoring. The role also requires implementing and maintaining advanced clinical trial management systems (CTMS), ensuring adherence to FDA, EMA, and other global regulatory requirements, and collaborating with cross-functional teams, including Medical Affairs and Regulatory Affairs, to support clinical programs and align objectives. The VP will serve as a key liaison with external partners and vendors while working towards building a strong in-house team, communicate clinical trial progress, challenges, and outcomes effectively to the CMO and other senior management members, and allocate resources strategically to support the efficient completion of clinical trials. Additionally, the VP will identify and mitigate risks to ensure the successful achievement of project timelines and goals, and perform any other assigned duties.

Responsibilities

• Develop and implement the clinical operations strategy to align with SystImmune's goals and objectives.
• Oversee the design, initiation, execution, and completion of clinical trials, ensuring alignment with regulatory requirements, budgets, and company standards.
• Foster a culture of excellence, innovation, and collaboration within the clinical operations team.
• Lead and manage the global clinical operations team (ex-China), including staffing, training, and professional development.
• Oversee the selection and management of the in-house team and enhance trial execution.
• Ensure the efficient and timely conduct of clinical trials, including site selection, patient recruitment, data management, and monitoring.
• Implement and maintain advanced clinical trial management systems (CTMS) and ensure effective use.
• Ensure adherence to FDA, EMA, and other global regulatory requirements.
• Cooperate with quality assurance and risk management processes to ensure data integrity and regulatory compliance.
• Collaborate with cross-functional teams, including Medical Affairs and Regulatory Affairs, to support clinical programs and align objectives.
• Serve as a key liaison with external partners and vendors while working towards building a strong in-house team.
• Communicate clinical trial progress, challenges, and outcomes effectively to the CMO and other senior management members.
• Allocate resources strategically to support the efficient completion of clinical trials.
• Identify and mitigate risks to ensure the successful achievement of project timelines and goals.
• Perform any other assigned duties.

Requirements

• Advanced degree in life sciences, clinical research, or a related field (PhD, MD, PharmD preferred).
• Minimum of 15 years of experience in clinical operations, including at least 10 years in a leadership role within the biopharmaceutical industry.
• Demonstrated experience in managing global clinical trials, particularly in oncology and ADCs.
• In-depth knowledge of FDA, EMA, and ICH GCP guidelines.
• Proven ability to build and lead high-performing teams, with experience in both small biotech and large pharmaceutical environments.
• Strong leadership, communication, and organizational skills.
• Experience with clinical trial management systems (CTMS) and other relevant software.
• Willingness to travel domestically and internationally as required.

Benefits

• Disability insurance
• Health insurance
• Dental insurance
• Paid time off
• Vision insurance
• 401(k) matching