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Director of Clinical Studies
2 months ago
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
