Sr. Clinical Operations Manager (Rare Diease/Oncology Experience Required)

Scorpion is a clinical-stage, precision oncology company developing transformational targeted therapies for patients with cancer. We have built proprietary and fully-integrated discovery capabilities leveraging the most advanced technologies across cancer biology, medicinal chemistry and data sciences. Our current pipeline, led by our mutant-selective PI3Ka program STX-478, consists of three internally discovered clinical product candidates in addition to multiple discovery-stage programs. Our focus is on solving current gaps in therapeutic options for patients with cancer by discovering and developing exquisitely-selective product candidates against well-validated, previously undruggable argets to improve patient outcomes.

Position Summary 

In this important role within Clinical Operations, the Sr. Manager is responsible for collaborating with clinical and regulatory functions to execute on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. The Sr. Manager will work as or with the Clinical Study Lead to ensure on time delivery of key tasks within a clinical study or the study itself. In addition to exceptional project delivery, we seek strong analytical skills, attention to detail, and leadership qualities that will influence our internal team and motivate our CRO partners. The ideal candidate values bringing important medicines to patients in need, and shares our team’s determined, positive attitude. 

Key Responsibilities

• Devise and implement efficient, effective clinical trial execution strategies; inform planning and monitor execution of clinical studies, including management of study budgets / timelines and external vendor(s) management. 
• Provide internal updates on trial progress to leadership with respect to project plans, timeline, budgets, quality standards, and regulatory compliance.
• In collaboration with or in the role of the Clinical Study Lead, Program level clinical operations leadership, and CRO (if applicable), ensure procedures and support are available to facilitate delivery of high-quality clinical data.
• Ensure compliance of clinical trials with federal and applicable regulatory agency requirements.
• Facilitate expert review and manage the generation, approval, and control of trial documentation, including but not limited to invoices, protocol, and informed consent documentation.
• Successfully partner with and oversee the CRO and their conduct of the clinical study (if applicable).
• Facilitate data lock and transfer of data for analysis. Coordinate data analysis and reporting in an efficient and timely manner. Complete trial reporting compliant to regulatory requirements.
• Ensure all project level documentation is filed in accordance with SOPs/regulatory requirements including archiving and maintenance. 

 Professional Experience/Qualifications

• BS/Associates Degree is required.  
• Preferred 6 or more years related work experience in clinical trials, with at least 2 years in a study management role at a sponsor or CRO. 
• Biopharmaceutical (Sponsor) organization experience is required.
• Rare Disease experience is preferred.
• Demonstrated effectiveness in resolving study management issues.
• Experience managing a broad project team in a matrix setting is required; direct line management is not required.
• In-depth knowledge of the CRO management strategies is required.
• Strong communication, project management, and data analysis skills;
• Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
• Prior NDA/BLA submission experience is desirable.
• Prior experience in Oncology drug development and Phase 1 trial execution is desirable.
• Up to 30% travel may be required to research sites, investigator meetings or vendor meetings. International travel may be required. 

Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.