Senior or Principal Consultant – Clinical Development

San Diego
 

Halloran is looking for a motivated Clinical Development professional to join our team. The successful candidate will have a proven record of clinical development experience within biotech and/or pharmaceutical companies with deep subject matter expertise in clinical trial management and program level responsibilities. This role will allow the right candidate an opportunity to work in a fun, but fast-paced environment, with experts in their field to foster continued professional development in clinical development.

Job Responsibilities
  • Develop clinical strategies to guide biotech and pharma companies thoughtfully through development 
  • Act as a development advisor, clinical operations leader, or project lead for multiple biotech and pharma companies, bringing real-world experience and an ability to roll up your sleeves and get the work done
  • Lead cross functional development teams as the clinical subject matter expert and related planning/implementation activities, focusing on, but not limited to early development strategic planning and first in human (FIH) through POC study designs
  • Work efficiently and collaboratively with sponsor C-level team members, sponsor development team members, and internal Halloran team members, and third-party consultants and vendors/CROs
  • Lead and/or key contributor to integration of cross functional development plans for pre-IND through Registration, including development of product profiles, risk assessment and mitigation strategies, alternative pathways, competitive landscape analysis, and gap analyses
  • Opportunity for line management of internal Halloran resources
  • Lead and/or contribute to development of proposals and scope of work documents and engagement with potential clients for new work as well as scope expansion for existing clients
  • Travel to clients’ office(s) and other locations as needed based on client and project needs, as well as internal Halloran business purposes
    • Up to 50% local travel/commute
    • Up to 15% domestic travel
  • Other duties may apply
Education and Experience Requirements
  • Bachelor's degree in life science or related field
  • A master’s degree or certifications in the area of expertise is a plus
  • 10-15+ years’ work experience in a biotech, pharmaceutical or healthcare industry company 
  • A proven record in creatively leading clinical development strategies, programs and clinical trial design and oversight
  • Key contributor to creation of clinical and integrated development plans as well as authoring relevant documents as a clinical subject matter expert (e.g., clinical protocols, Investigator Brochures, ICFs, study pans, Pre-IND documents, IND modules)
  • A proven record in line management, performance management, people development, and organizational growth is preferred
  • Proved ability to gather, compile, and assess relevant literature, data and metrics to guide decision making and establish strategic plans, timelines, and budgets
  • Exposure to multiple therapeutic areas, product types, and routes of administration. Experience in oncology, adaptive design studies, and medical device/combination therapies all a plus
  • Deep familiarity with current regulatory guidance, good clinical practice, legislation, industry trends, health care / business practices in drug development 
  • Highly proficient in the MS Word, Excel, Project, and PowerPoint
Characteristics of Top Performers
  • Broad clinical experience across a variety of therapeutic areas, oncology experience highly desirable 
  • Exceptional interpersonal, presentation and communication skills
  • Action oriented, ready for responsibility, open to learning new skills and willing to help where and when needed
  • Successful collaborator and communicator with clients and internal management and an ability to coach team members  
  • Demonstrated ability to lead independently with exceptional organization and attention to detail 
  • Proactive planner for strategies to account for risks and opportunities as data, trends, and client needs evolve
Halloran Consulting Group | Senior or Principal Consultant – Clinical Development