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Director or Sr Director, Clinical Operations

San Diego, CA or remote

Erasca is a San Diego based biotechnology company focused on discovering and developing precision medicines for the benefit of patients with cancer. We are advancing multiple programs targeting biological drivers of cancer and are pursuing additional pipeline expansion opportunities through academic and biopharmaceutical collaborations. Our programs, currently focused on innovative discovery research, take novel approaches to shutting down certain oncogene drivers of solid tumor malignancies. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

Position Summary: 

Reporting to the VP Clinical Research & Operations, the Director or Senior Director of Clinical Operations will plan, implement, and manage clinical studies and clinical research projects from concept to completion. The position requires advanced knowledge of clinical trial processes and proficiency in all aspects of trial execution from study start-up to study close-out, including management of clinical vendors/CROs and providing oversight of resources, budgets, contracts, and timelines. 

Note that the position will be filled at the Director or Senior Director level depending on the candidate's experience and the program or business need.  

Essential Duties and Responsibilities: 

  • Manage global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements. 
  • Recruit global study sites and foster relationships with study investigators. 
  • Participate in the process of site and vendor selection, qualification, and activation. 
  • Develop Requests-for-Proposals and lead vendor selection efforts. 
  • Assist in review and negotiation of vendor contracts and study site clinical trial agreements. 
  • Manage study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging). 
  • Monitor the progress of trials, including enrollment and clinical trial material inventory. 
  • Assist in packaging/labeling/distribution of clinical trial material. 
  • Monitor and track biological samples for applicable analyses. 
  • Provide progress updates to management and during program team meetings. 
  • Assist in departmental budgeting, including accruals and projections. 
  • Assist in development of protocols, consent forms, IRB/EC materials, and other trial documents. 
  • Assist in development of Clinical SOPs. 
  • Prepare/review/approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports. 
  • Assist in electronic case report form design and development. 
  • Assist in IRT design and development. 
  • Participate in data cleaning activities and developing appropriate data outputs. 
  • Understand and help fulfill the needs of other Erasca departments (e.g., Finance, Research). 
  • Provide leadership and mentoring of other Clinical team members. 
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Required Education and Experience: 

  • Undergraduate degree in life sciences or professions (pharmacy, medicine, nursing, or other allied health sciences). 
  • At least 10 years of relevant experience in clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3). 
  • Extensive experience in Oncology drug development. 
  • Experience in a startup or rapidly evolving organization required; a combination of large company and small company experience preferred. 
  • Demonstrated excellence in trial management skills, with track record of successfully managing multiple projects, trials, and priorities. 
  • Experience with managing study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging). ·  
  • Proven ability to work well with global, multi-disciplinary teams. 
  • Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations. 
  • Experience with electronic data capture and data management software. 
  • Experience in the management of Clinical Trial Managers and Clinical Research Associates. 
  • Excellent oral and written communication skills. 
  • Must be able to work independently and thrive in an entrepreneurial, fast paced and dynamic work environment. 
  • Strong learning orientation, curiosity, and passion for science and patients. 

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

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