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Director or Sr Director, Clinical Development

San Diego, CA or remote

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. 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.

 Director or Senior Director, Clinical Science 

Position Summary: 

Reporting to the SVP Clinical Development, the Director or Senior Director, Clinical Development will support and may lead the clinical aspects of one or more clinical development studies or programs. This individual is responsible for the planning and execution of clinical studies to successfully move the program from IND through to later stage trials. This person will work closely with cross-functional teams in the management, and execution of the Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and in ensuring the successful execution and completion of clinical trials. In addition, the Director or Senior Director, Clinical Science will have individual study level responsibility.

Essential Duties and Responsibilities:  

  • May design and will oversee and execute clinical deliverables in support of CDP. May be responsible for multiple studies as programs expand and move into later-phase trials. 
  • May lead the cross-functional Clinical Development sub-team in partnership with other Clinical Development and Clinical Operations personnel.  
  • Key clinical deliverables include document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review, and other deliverables as needed. 
  • May attend and contribute at meetings with Health Authorities (HAs) related to program; develop responses to HAs and IRBs on clinical/medical questions. 
  • Represent Erasca externally at scientific meetings and congresses. 
  • Manage other clinical scientists, if appropriate based on organizational structure and business need, and participate in the building of a high functioning clinical science function. 
  • In collaboration with other functions and stakeholders, create functional policies and procedures to provide strong and efficient clinical development processes that are scalable and fit for purpose.  
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Required Education and Experience: 

  • Undergraduate degree required; PhD, PharmD, or other relevant advanced degree in a health science field highly preferred. 
  • At least 8 years of biotech or pharmaceutical industry experience as a clinical scientist or in a related clinical development function. 
  • Experience in oncology clinical trials required, early development experience a plus.  
  • Experience in a dynamic start up or small company environment preferred. 
  • Demonstrated ability to evaluate, interpret, and present complex scientific data.  
  • Deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles. 
  • Proven track record of successfully delivering projects on time, to budget and required quality. 
  • Excellent verbal and written communication and presentation skills. 
  • Management experience or the desire to develop as a manager, mentor, and leader of staff. 
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems. 
  • 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.