Senior Director, Clinical Development

Clinical San Diego, California


Description

ORIC Pharmaceuticals, Inc, is a clinical stage oncology company dedicated to improving patients’ lives and focused on developing treatments that address mechanisms of therapeutic resistance. We are seeking an accomplished clinical development leader who will be responsible for Implementation of clinical development plans, focusing on innovative clinical trial design, study execution and data interpretation and communication.  A deep knowledge of Oncology clinical development, combined with scientific knowledge, critical thinking, active listening, complex problem solving, and decision-making abilities, are critical skills for this position.      
Interacts with Research and other internal departments, such as Finance, and with external parties, including clinical collaborators, third-party vendors, and contract research organizations (CROs), with the objective of establishing and leading the clinical development strategy for one or more of ORIC’s clinical development programs.     
The successful candidate will report to the Senior VP, Clinical Development and will be responsible for the following.     
  • Serve as the Clinical Lead for one or more pipeline products
  • Develop and/or assist in the production of clinical documents required for the conduct of clinical studies, such as clinical protocols, informed consent documents, investigator’s brochures, and miscellaneous study management plans in compliance with federal regulations and good clinical practices
  • Provide ongoing data interpretation and medical writing of study reports, conference abstracts, and manuscripts for publication
  • Safety data review and management of internal/external data monitoring committees
  • Prepare or assist with clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages
  • Represent clinical development on internal multidisciplinary project teams
  • Present clinical program at Site Initiation Visits, Investigator’s Meetings, and scientific conferences
  • Lead teleconference and/or face-to-face meetings with Investigators
  • Partner with Clinical Operations to drive key deliverables
  • Provide clinical development review of potential in-licensing opportunities
  • Provide direct management, leadership and mentoring of other junior Clinical Development team members
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations
Experience:     
  • MD, PhD, MD/PhD with 5+ years of clinical development experience in industry setting preferred; MS/RN/PharmD with 10+ years or BS (Science degree) with 15+ years
  • Oncology therapeutic area expertise; experience in solid tumors, particularly lung cancer and/or prostate cancer highly desirable
  • Phase 1-3 studies with experience with translational medicine, precision oncology, global studies, from early development through NDA highly desirable
  • Expected competencies: ICH/GCP guidelines
  • Effective written/verbal communication (eg, able to adjust style/contents to suit the audience/purpose; includes public speaking)
     
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or  any other legally protected characteristic.  
  
    
    
    The anticipated salary range for candidates in San Diego is between $250,000-$300,000.  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.  ORIC is a multi-state employee, and this salary range may not reflect positions that work in other states.