Vice President, Clinical Operations

Redmond, WA

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.

Job Summary:

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:

• 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.
  

Required Skills & Qualifications

• 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.

The hiring pay range for this position is $330,000 - $370,000 per year based on skills, education, and experience relevant to the role.

SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]

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