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CHIEF MEDICAL OFFICER (CMO)

Date Posted: 7/23/2020

JOB DESCRIPTION

Spectral MD, Inc.

Position Title: Chief Medical Officer (CMO)

About Spectral MD, Inc.

 

Spectral MD, a mid-stage medical device company, is developing a diagnostic imaging system to support treatment decisions by healthcare professionals in the wound care market, especially burns and chronic wounds. We focus on the combination of AI and machine learning techniques with digital images to meet the needs of our clinician customers in wound management.

Position Overview:

Spectral MD is seeking a leader and strategic thinker to serve as our Chief Medical Officer (CMO). The CMO will be responsible for constructing and maintaining a strategy for bringing new medical devices to market. They will work with the technical and commercial teams to build and manage new and existing pipelines of revenue generating opportunities. This position will offer the opportunity to become highly educated in the ways machine learning and deep learning can be leveraged for better delivery of healthcare.

Responsibilities:

  • As a member of the Executive Team, participates in corporate strategic planning and integrate clinical development goals into Spectral MD’s overall business plans.

  • Responsible for the overall clinical development program strategy, planning, and execution which includes:

  • Leading, Clinical Operations, Medical Affairs and Regulatory functions within Spectral MD.

  • Development and implementation of innovative clinical programs, clinical trials, clinical research and data collection activities.

  • Design and implementation of clinical protocols.

  • Recruitment and retention of steering committees and external collaborations.

  • Timely execution of trials through final reports.

  • Producing integrated summaries supporting regulatory submissions.

  • Oversee the management of relationships with third parties, such as CROs, investigator sites, and collaboration partners to timely implement human clinical studies and reviewing clinical data for a variety of wound related clinical trials

  • Manage, mentor, and build a highly effective Clinical Operations team; identify clinical team members for Spectral MD.

  • Provide support for corporate and commercial activities that are highly dependent on the accurate communication of clinical or scientific data (e.g., payor engagement).

  • Develop processes and procedures to ensure patient safety, including implementing proper monitoring reports and protocols.

  • Develop and maintain professional and credible relationships with key opinion leaders.

  • Conduct advisory boards, deliver scientific presentations, and utilize medical insights from the field teams to inform product planning.

  • Contribute to, reviews and approve medical/scientific communications including marketing materials and participate in Promotional and Scientific Content Approval Processes.

  • Responsible for generation and dissemination of data. Ensure timely publication planning and communication activities in support of Product Strategy and Life cycle Management Plan.

  • Ensure effective team communication, performance and documentation of Medical Affairs activities and knowledge.

  • Maintain knowledge of professional information and technology through conferences and medical literature; acts as wound area resource.

  • Provide clinical insight and leadership to ensure that Spectral MD achieves its clinical goals and identifies compelling new opportunities.

  • Oversee the clinical assessment of business development opportunities.

  • Represent Spectral MD as the senior clinical spokesperson to scientific, business, investor, and government groups/agencies; build effective KOL relationships.

  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.

 

Qualifications:

  • M.D. required, Previous experience in the biotechnology/medical device industries and expertise in wound care are preferred.

  • Effective leader who inspires others to contribute fully to meet team objectives.

  • Demonstrated track record of success in the design, execution, monitoring and management of clinical trials for medical devices. Demonstrated the ability to oversee clinical trials as medical expert

  • Successful IDE experience is required, including leading interactions with the FDA.

  • Demonstrated ability in leading and building a clinical development team in a matrixed organization, including organizational design and the recruitment and development of talent.

  • Ability to identify unmet clinical needs, evaluate product opportunities from a clinical perspective, and develop clinical research that collectively leads to the efficient development of such opportunities.

  • Experience building and managing collaborations, consultants and outsourced work, including CROs. A track record of conscientious financial management.

  • Experience with FDA's 510(k) pathway. A thorough understanding of the regulatory requirements for medical device clearance. A record of active participation in the preparation of regulatory submissions, including a lead medical role in submission-related meetings and discussions with the FDA.

  • Responsible, dynamic, creative and highly motivated MD to lead clinical development strategy to achieve earliest possible human clinical trial clearance.

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