Head of Clinical Development

Employer
Adiutm Bio
Location
Open to candidates in the Bay Area, New York and Boston
Salary
Commensurate with experience; considering leadership candidates with advanced degrees
Posted
Aug 19, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

Summary

Aditum Bio is an investment fund focused on acquiring pharmaceutical assets and developing them to generate a return for our limited partners. Aditum is Latin for “access” and our mission is to provide access to medicines that otherwise may not be developed to patients in need.

The head of Clinical Development is responsible for leading the overall development and execution of the Aditum Bio’s clinical trial program. This includes the strategic direction of the clinical program, and executing together with TrialSpark.  

Specific Responsibilities:  

  • Selection of Therapies to In-License:  Working closely with the partners to evaluate and conduct due diligence on assets under consideration for in-licensing. Includes competitive assessment, development of Target Product Profile, and assessment of probability of success.  Also includes developing preliminary clinical development plans to assess probability of success, costs and timing for consideration prior to in-licensing.  
  • Clinical Strategy:  Lead the development of each therapy’s overall clinical development strategy, to ensure the greatest probability of success.  
  • Program Planning and Execution:  including protocol development, early communication with regulatory agencies, and the clinical trial plan. Execution includes working closely with TrialSpark to execute the trial, monitoring of clinical sites, and interpreting the statistical analysis of the trial data.
  • Partner Collaborations:  Manage the relationship with any external partners, while ensuring that the interests of the Aditum Bio are protected.  

Qualifications  

  • Medical Doctor (MD) with experience in early (Phase 1 and 2a, or “proof-of-concept (PoC)” trials) across a range of non-oncological indications including, for example, autoimmune, respiratory, dermatological, or ophthalmological diseases.  
  • Pharmaceutical/biotech industry experience (minimum 5-7 years) guiding new drug clinical development program, preferably for both small molecule and biologic drug candidates
  • Leadership and management experience in the planning and execution of clinical drug development trials, including execution through a CRO.  
  • Experience meeting with and presenting to the FDA and EMA, regarding execution of clinical trials.  
  • Proven ability to work collaboratively internally and externally
  • Results oriented and self-assured.