Vice President, Clinical Development - Immunology

At Aditum Bio our mission is to provide access to medicines to patients in need.   Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies and advances them into Phase 1 and Phase 2 clinical studies to enable proof of concept.   The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

Position Summary

Aditum Bio is seeking a Vice President, Clinical Development - Immunology, with a career focus in clinical development who will support the overall execution of designated Portfolio Companies’ clinical trials. This includes partnering closely with internal medical and clinical operations teams, as well as with key external partners such as CROs, investigators and consultants. The ideal candidate has a demonstrated command of early phase drug development and a track record of working successfully with highly matrixed cross functional teams. 

Position Responsibilities 

• Clinical Trial Execution
• • Lead the execution of clinical studies for assigned portfolio companies
  • Support, in collaboration with the CSO, Immunology and clinical operations leadership, the design and implementation of clinical development plans in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements and emerging issues
  • Maintain a high level of clinical and scientific expertise in a disease area(s) and relevant pathways by reviewing the literature, attending medical/scientific meetings, and through  interchanges with consultants, thought leaders, investigators and internal stakeholders

• Safety Oversight
  • Review and assess adverse events
  • Driving go/no go decisions based on safety signals
  • Ensure compliant safety reporting procedures

• Medical Monitoring
  • Oversee medical monitoring of ongoing trials
  • Review and address screening failures and protocol deviations

• Site and Investigator Guidance
  • Provide medical guidance to clinical research sites
  • Train site staff on medical aspects of protocol
  • Field and address investigator questions

 Qualifications 

• MD or MD/PhD with a minimum of 6 years of industry experience in clinical development in a pharmaceutical or biotech company setting
• Deep experience working on early stage development programs and design (pre-IND, IND; deep experience in both Phase 1 and 2 required)
• Ability to run a clinical program with minimal direction
• Experience running immunology programs strongly preferred 
• 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
• Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team oriented and decisive
• Experience leading within a matrix organization, with excellent communication skills, managing vendors and contract research associations