Senior Director, Clinical Development [Remote]

Company Overview 

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 Senior Director, Clinical Development with experience in Phase II development who will own the overall design and execution of designated Portfolio Companies clinical trials. This includes the translation of preclinical data into clinical trial design and execution, clinical trial strategy and protocols.  The ideal candidate has a demonstrated command of early clinical phase drug development and a track record of working successfully with highly matrixed cross functional teams.  

Position Responsibilities 

• Clinical Trial Design & Oversight
  • Design and oversee early-phase clinical studies for assigned portfolio companies to enable rapid entry to clinic and proof of mechanism
  • Support, in collaboration with the Medical 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
• 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

The range for this full-time position is $335,000 - 375,000, plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.

We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.