Now Hiring - Director of New Business Strategy & Innovation (New Product and Clinical Development) in Newton, MA

Position Title: Director of New Business Strategy & Innovation (New Product and Clinical Development)

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: Vice President, New Business Strategy and Innovation

Summary

Director of New Business Strategy & Innovation (New Product and Clinical Development)Lumicell is seeking a highly motivated individual to work in a dynamic, fast-paced start-up environment. This is an excellent opportunity to join a company with a well-validated platform and a lead product poised to launch in 2023. A proven track-record in medical device product development and clinical research is vital for the successful candidate.

The Director of New Business Strategy & Innovation (New Product and Clinical Development) will drive efforts to develop Lumicell’s fluorescence imaging technology in new/expanded indications. A successful candidate will have a minimum of 10+ years’ experience in medical device product development, including efficient and robust clinical trial design for evaluation of medical devices.

Major Responsibilities:

Product Development

• Define and document design of medical devices under design control per 21 CFR 820.30.
• Capture user needs and develop design requirements necessary to achieve desired performance according to the development stage.
• Perform risk analyses by analyzing failure modes and device/clinical effects.
• Develop and execute necessary bench, laboratory, analytical and/or animal testing strategy to demonstrate proof-of-concept and that design outputs meet design requirements.
• Manage PD timeline consistent with business needs.

Clinical trial strategy, planning and execution

• Develop protocols for early feasibility medical device clinical studies including methods, endpoints, and data to-be-collected within clinical report forms.
• Work closely with the Biostatistics/Data Science team to develop the statistical analysis plan, interim analysis plans and data readout.
• Work with the clinical trial affair team/trial manager to manage timelines for clinical trial site selection, activation, enrollment, and data lock and develop study document including CRFs, CRF completion guidelines and study training materials.
• Write and submit peer reviewed manuscripts as well as abstracts for conference presentations.

Regulatory Submission

• Prepare technical aspects of regulatory submissions: experience with Q-subs and IDE submissions preferred.

Position requirements and experience

• Graduate degree in biomedical engineering, bioengineering, mechanical engineering, physics, or related fields preferred.
• Excellent written and oral communication, analytical, and problem-solving skills.
• 10+ years of medical device product development leadership experience; both as an individual contributor and as part of a cross-functional team.
• Experience developing medical imaging or fluorescent imaging technologies preferred.
• Experience with clinical trials incorporating endoscopes a plus, including attending surgeries/medical procedures, providing real-time/intraoperative feedback to physicians and post-operative feedback to the study team.
• Start-up experience preferred.
• Experience designing and running small, early-stage clinical trials including writing study protocols and assisting in designing case reports to ensure proper data collection
• Experience fostering clinical collaborations with academic investigators is a plus

Supervisory Responsibility:

• This position has no supervisory responsibilities.

COVID Policy:

• Lumicell has an implemented and strictly enforced a COVID Policy that’s intended to keep all employees safe when working on-site
• Lumicell has also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.

Position Type/Expected Hours of Work

• This is a full-time position. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
• This job operates in a professional office environment located in Newton, MA. The successful candidate is expected to work at least three days per week on site at the Newton office but may otherwise work from home as needed.

Travel

• Some travel may be expected for this position including internal meetings, observing medical procedures, conference and/or training events.

EEO Statement

• Lumicell is an equal opportunity employer

Other Duties

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

To apply for this position, please send your resume to [please apply online].