Director of Clinical Studies

LifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring. 

We are seeking an experienced, collaborative, hands-on leader accountable to drive the design, implementation, and execution of clinical development programs that support the LifeLens growth strategies.   This person is a key member of the leadership team and will work cross-functionally within LifeLens and with external partners to ensure evidence-generation programs meet product development (and financial) milestones and requirements for regulatory submissions and market access, reimbursement, and commercialization of the LifeLens Technologies platform. 

This is an on-site position. Some travel may be required.

Essential Functions:

• Leads the design of Clinical Projects including development of trial protocols and budgets, CRO/vendor selection, investigator/site selection, data collection and analysis plans, and publication strategies.
• Develops collaborative relationships with key investigators and clinical thought leaders.  Oversees and attends clinical advisory boards and investigator meetings.
• Guides and supports operational trial management activities including budgets and timelines, CRO/vendor oversight, site monitoring, and conflict/risk mitigation.
• Ensures trial operations adhere to clinical protocols and terms of the study and are performed in line with LifeLens’ Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP).
• Contributes to and critically reviews regulatory submissions and pre- / post-submission interactions.
• Provides Clinical Program updates, including trial status/metrics, budget, accomplishments, and risks to Senior Management and other relevant stakeholders.
• Collaborates with senior management to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
• Leads and/or participates in continuous improvement initiatives to ensure SOPs for clinical development and execution facilitate effective clinical research programs and are compliant and evolving with clinical/medical regulations and industry standards.
• Travels as necessary to facilitate and support clinical trials and investigator interactions

Competencies:

• Bachelor's degree in a scientific or health-related field required.
• Master's degree in a scientific or health-related field is preferred.
• PMP certification preferred.
• Minimum of 10-12 years of medical device clinical research experience, including on-site monitoring experience.
• Minimum of eight to ten years of experience in the management of clinical trials as a project manager or other relevant experience at a med-tech/pharmaceutical/biotech company or CRO.
• Minimum of four to six years of prior supervisory experience required.
• Expert knowledge of FDA regulations and US 21 CFR 820 and EU 13485 quality system requirements required
• Strong ability to prioritize tasks and keen attention to detail.
• Excellent written communication, and presentation skills.
• Demonstrated leadership and project management skills.
• Proven ability to work on multiple projects in a fast-paced environment.
• Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.
  

Benefits:

• Health Insurance
• Dental/Vision Insurance
• Paid Time Off
• Flextime
• Stock Option Incentive Plan