Clinical Development SME

Tunnell Consulting   •  

San Francisco, CA

8 - 10 years

Posted 243 days ago

This job is no longer available.

Key responsibilities will include:

  • Apply strategic and technical/scientific expertise to lead integrated clinical development plans for vaccine development in support of rapid response vaccine platforms and the acceleration of vaccine development coupled with improvement vaccine coverage supporting diseases with epidemic/pandemic potential. 
  • Consult, provide technical expertise and thought partnership, to maximize the impact of projects and the creation of well-integrated vaccine clinical development plans, clinical study designs, statistical analysis plans, and clinical assays for vaccine clinical studies.
  • Serve as an advisor on clinical vaccine study design; including the review of protocols, analysis plans, and clinical sections of regulatory dossiers. 
  • Lead product development process
  • Support cross-cutting initiatives/sub-initiatives to accelerate vaccine clinical development
  • Support the evaluation of new vaccine technologies; providing input on potential clinical development pathway. 

The following experience is particularly desired: 

  • Deep expertise in infectious diseases and/or clinical immunology; with an emphasis on knowledge of epidemic infectious diseases coupled with a minimum of seven years of industry experience working with different vaccine platforms and across a range of disease areas, or, Experience working on cross-functional product development plans in a role requiring creative problem solving

Education and Experience 

You should have:

  • Extensive knowledge of clinical vaccine research from phase 1 through phase 4 
  • Significant knowledge of vaccines including major challenges to development. 
  • Demonstrated ability to learn new disease areas and new vaccine technologies quickly. 
  • An understanding of regulatory requirements necessary for the various phases of vaccine development and experience interacting with regulators in all geographic regions. 
  • Experience with business and technical due diligence assessments of potential investments. Ability to synthesize technical and commercial information toward strategic decision making.
  • Demonstrated ability to lead and affect data-driven strategy planning and implementation. 
  • Demonstrated experience with team management; including experience developing cross-functional and diverse (e.g. culturally and professionally) teams. 
  • Intellectual quickness, curiosity, discipline, resourcefulness and resilience. 
  • Strong judgment with a demonstrated ability to handle complex issues, multiple tasks, confidential information, and competing priorities with skill, discretion, a strong attention to detail, flexibility and diplomacy. 
  • Excellent interpersonal and diplomatic skills.
  • Demonstrated excellence in scientific writing and data analysis, written and oral communication skills, and experience advocating and communicating with a broad and diverse audience. 
  • Understanding of how to navigate and operate within a complex, matrixed environment.