Senior Director/Director of Study Start-up

SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. 
 

We are seeking a dedicated and detail-oriented Senior Director/Director of Study Start-up to join our dynamic and growing clinical trials team in oncology. The successful candidate will be responsible for overseeing study start-up across all assets.  The Sr. Director/Director of study start-up plays a crucial leadership role in overseeing and optimizing the early phases of clinical trials. This position ensures that studies are initiated efficiently, regulatory approvals are secured, and operational strategies align with company objectives. This role requires extensive experience in clinical operations, regulatory affairs, and project management. 

Responsibilities: 

• Strategic Leadership: Define and drive study start-up strategies that improve efficiency and accelerate trial activation. Partner with senior management to align study start-up goals with broader clinical development objectives. Oversee study start-up teams, ensuring operational excellence, compliance, and cost-effectiveness. 
• Ethics/IRB & Compliance: Lead ethics/IRB approvals across multiple regions, ensuring adherence to ICH-GCP, FDA, and EMA guidelines. Collaborate with internal and external stakeholders to mitigate regulatory risks and navigate approval challenges. Maintain oversight of trial documentation, ensuring timely submission and compliance with regulatory requirements. 
• Cross-functional Collaboration: Work closely with study teams and legal department to optimize trial initiation. Establish strong relationships with investigational sites, vendors, and regulatory authorities to expedite approvals. Provide leadership, mentorship, and training to study start-up specialists, fostering a high-performance environment. 
• Process Optimization & Risk Management: Identify inefficiencies in study start-up workflows and implement process improvements. Develop risk mitigation plans for site activation delays, contract negotiations, and regulatory hurdles. Leverage technology and data analytics to enhance study start-up execution and decision-making. 

Qualifications: 

• Bachelor’s degree required; Master’s degree preferred (Life Sciences, Clinical Research, or related field). 

• 10+ years of experience in clinical trials, with a strong focus on study start-up; Director-level candidates may require slightly fewer years. 

• Extensive knowledge of global regulatory requirements and clinical trial operations. 

• Proven leadership in managing study start-up processes and cross-functional teams. 

• Strong strategic thinking, problem-solving, and project management skills. 

• Line Management experience.

• Excellent written and verbal communication skills. 

• Strong attention to detail and organizational skills. 

• Proficiency in Microsoft Office Suite and other relevant software. 

• Experience with logistics and supply chain management for clinical trials. 

Preferred Qualifications: 

• Experience in developing and maintaining clinical trial documentation. 

• Certification in clinical research (e.g., ACRP, SOCRA). 

• Experience in a global setting, managing trials across diverse regulatory environments. 

• Experience in Trial Trove and/or Citeline.

• Proficiency in study start-up technology platforms, including clinical trial management systems (CTMS), specifically VEEVA. 

• Demonstrated success in process optimization and risk mitigation strategies. 

• Advanced understanding of budget planning and contract negotiations related to study start-up. 

Working Conditions: 

• Environment: Hybrid position out of NJ, Princeton office. 

• Travel: Travel may be required based on business needs. 

The expected base salary range for this position is $180,000 - $220,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. 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. 

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.