Currentjob openings

Senior or Executive Director Clinical Development

Position Summary:    

Reporting to the SVP Clinical Development, the Senior or Executive Director Clinical Development will provide strategic input to the clinical development plan as well as lead the planning, execution, and interpretation of one or more clinical development programs.  

Essential Duties and Responsibilities: 

• Strategic input on clinical development plans for which they are the clinical lead. 
• Lead, design, and implement clinical studies and programs in support of the overall Clinical Development Plan. 
• Clinical lead on one or more molecule programs. 
• Primary responsibility for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.  
• Lead clinical study teams, monitoring overall study integrity and review, interpretation, and communication of data. Along with Clinical Operations, responsible for ensuring study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events. 
• Act as medical monitor on one or more clinical studies. 
• May manage and/or oversee the work of other members of the clinical development team including physicians and/or non-physician scientists.  
• Serve as in-house medical expert for one or more molecules or disease areas, coordinating and leading scientific and medical activities with internal and external stakeholders. May participate in or lead clinical development contributions to due diligence or other business development activity. In partnership with Research colleagues, contribute to design and implementation of clinical translational strategies. 
• Lead KOL engagement activities and opinion leader interactions, develop and execute publication plan, and represent Erasca at external meetings. 
• Understand, incorporate, and accountable for compliance with regulatory requirements for clinical studies and global drug development. Serve as a clinical representative for key regulatory discussions. 
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Required Education and Experience:  

• MD (or ex-US equivalent) or MD, PhD with board certification or eligibility in oncology/hematology highly preferred; extensive industry experience in Oncology drug development may take the place of formal training. 
• 5+ years of industry experience required including Phase I/II early development experience, late stage and/or registrational experience a plus. 
• Small company experience desired. 
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols. 
• Strong understanding of translational disease biology and ability to design innovative trials based on emerging biomarkers and clinical outcome measures. 
• Familiarity with areas of drug discovery and early drug development, including chemistry, biology, toxicology, and early clinical development will be helpful.  
• Proven ability to independently run a complex clinical research program. 
• Proven leadership skills and ability to bring out the best in others on a cross-functional team. Must be able to lead through influence. Direct management experience a plus. 
• Ability to interact externally and internally to support scientific and medical strategy. 
• Strong organizational, analytical, and problem-solving skills. 
• Ability to multi-task and support multiple projects. 
• Excellent written and oral communication skills with demonstrated ability to present ideas, information, and data effectively via one-on-one discussions, team meetings, and partnership interactions. 
• Thrives in a team-based environment, cooperative and supportive of multiple viewpoints and approaches. 
• Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and thrive in a small company environment. 
• Intellectually curious with strong learning orientation and passion for science and patients.