Posting Date: August 1, 2023 - Full Time, Boston Campus

AVS is an early-stage medical device company that is focused on safely and effectively treating severely calcified arterial disease. AVS is the first company to develop pulsatile intravascular lithotripsy (PIVL), a therapy that is delivered through a balloon-based platform called the Pulse IVL System. It is designed to be the only minimally invasive technology that gently shatters calcium and opens the artery using a single device. We are seeking an exceptional and highly motivated clinical leader as Director/Senior Director, Clinical Development.

The Clinical Director is responsible for leadership and implementation of AVS’ clinical strategy. This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations. The CD leads the clinical team and is responsible for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership.

Responsibilities:

  • Responsible for development and implementation of operational strategy, driving study budget and timelines from Clinical Study Concept through Final Protocol
  • Review plans and provision of clinical operations expertise during protocol design, feasibility, study and conduct phases of studies. Ensure consistency within the program and development of best practices
  • Responsible for clinical study budgets, review, presentation and approval of initial study budget and handles the budget through the lifecycle of the program by communicating changes to Leadership, as appropriate
  • Direct and oversee the overall strategy for clinical development, collaborating with Regulatory bodies
  • Directly supervise and monitor in-house clinical team and external partners during trial conduct to ensure patient safety and data integrity
  • Lead/author of clinical portion of regulatory submissions and responses to regulatory agency questions
  • Communicate findings via verbal and written communications and visual presentations both internally and externally
  • Maintain an overview of clinical status and issues and proactively presenting progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to partners as requested
  • Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
  • Coordinate and communicate clinical study timelines
  • Provide input and operational insight into Clinical Study Concepts (CSC)

Qualifications:

  • Proven track record in leading clinical teams, trials and development in a biotech company
  • Master’s in a science or health related field (PhD preferred)
  • At least 10 years of clinical research experience in global clinical trials with a minimum of 7 years medical device
  • Early clinical development experience is required.
  • Has managed multiple trials through successful 4lauches (510ks, PMA, international)
  • Advanced interpersonal & leadership skills
  • Ability to provide operational strategic direction and guidance for clinical programs, understands all aspects of trial design & execution
  • An understanding of relevant industry trends
  • Strong analytical skills with a data driven approach to planning, executing, and problem solving
  • Ability to influence and negotiate across a wide range of senior partners (i.e., functional area heads)
  • Budget management expertise and strong financial savvy
  • Expert project management skills, cross-functional engagement, organizational skills with experience in building teams / organization to meet the activity needs

APPLY