Design and implement translational strategies for the efficient advancement of clinical programs from phase 1 through pivotal clinical trials.
Collaborate with Development Program Leaders to integrate, document, and communicate Translational plans, track progress, and re-forecast as necessary in conjunction with the team.
Maintain close working relationships with translational team members and functional departments (e.g., Research, Nonclinical, CMC, Clinical, Regulatory, Quality, Program Management) to ensure that all critical parties are aware of translational activity, issues, and contingencies.
Demonstrate a strong appreciation for research with a focus on translational science and product development.
Track key milestones, deliverables, risks and dependencies, flag potential delays, and drive mitigation plans.
Organize team meetings including agendas, pre-work, minutes, action items and overall translational team correspondence including management of timelines, deliverables, metrics, and budget.
Develop and implement communication tools that enhance information exchange and stimulate creative project interactions.
Work in concert with Program Leaders in preparing slide decks and information for ongoing project team meetings, reviews, board meetings, scientific presentations, and other appropriate meetings that involve progression through the key decision points of a program.
Be a champion of change, propose solutions to problems, support company decisions, and help teams to understand factors and priorities leading to decisions.
Requirements
Ph.D. or Masters degree in a scientific field with demonstrated business acumen and 7+ years experience or equivalent combination of education and experience
4+ years experience in translational project leadership or program management in the biotechnology/pharmaceutical industry
Knowledge of the drug development process, particularly early-stage clinical trials; strong understanding of technical, business, and regulatory issues
Strong knowledge of MS Office and MS Teams and experience working with program/project management tools, including Smartsheet
Experience managing external vendors and cross-functional teams.
Excellent verbal and written communication, negotiation, team building, presentation, and interpersonal skills
Established ability to work independently, prioritize and manage multiple tasks simultaneously, and demonstrated ability to identify and resolve issues
Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.
PMP certification (preferred)
Tech Stack
PMP
Benefits
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.