Associate Director / Director, Program Management

Location
Menlo Park, CA, United States
Posted
Feb 03, 2021
Ref
496470834
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

The Associate Director / Director, Program Management will lead one or more cross-functional drug development program teams including research, development, and commercial representatives.

Essential Duties/Tasks

  • Lead and coordinate all cross-functional activities related to clinical development, CMC, and regulatory for a new therapeutic
  • Develop integrated development plans and drive execution. Anticipate issues and proactively mitigate risks and roadblocks. Direct program team to achieve targets within appropriate quality standards, deadlines, budget, and resources
  • Drive program level decision-making
  • Ensure appropriate and effective communication within the program team, senior management, and the executive team, including the CEO
  • Represent development point of view in commercial planning and decision making
  • Provide formal and informal reports of program status to stakeholders


Education and Experience

 

  • Master's Degree in a life science or related field or equivalent experience
  • At least 10 years project management experience in drug development in the pharmaceutical industry, including Phases 1-3, regulatory filings and product launch
  • PMP or other Project Management Institute certification


Skills, Qualifications, or Technical Proficiencies

 

 

  • Demonstrated leadership skills and ability to manage, motivate, and integrate complex, cross-functional development teams
  • Analytical skills and ability to focus on both details and the big picture
  • Excellent interpersonal, problem solving, and influence/negotiation skills
  • Knowledge of regulatory guidelines for drug development functions (ICH and FDA)
  • Able to navigate uncertainty with creative problem solving
  • Ability to achieve business results with colleagues of diverse levels, functional expertise, skills, and priorities. Effective as both a team player and a team leader
  • Ability to take a hands-on, "roll up your sleeves" approach