DermaSensor, Inc
Chief Medical Officer
Miami, FL
·
Full time
We are seeking a Chief Medical Officer to join the DermaSensor team. Join our medical device startup and help improve skin cancer detection. You will lead the development of our global clinical development and medical affairs strategy as well as build out the clinical development and medical affairs teams (currently comprised of two team members). You will have significant responsibility and the opportunity to make a difference in patients’ lives while working with a dynamic team and highly respected physicians and scientists. In joining our team, you'll enjoy a competitive salary, a great equity package, and a creative and flexible work environment. You will also be a key determinant of the success of our mission to improve access to skin cancer detection.
Description
The Chief Medical Officer will:
- Refine and finalize the company’s strategy for evidence generation to achieve widespread payer coverage
- Lead the planning and execution of post-market studies, and other real-world evidence generation efforts, in working with our clinical operations and medical affairs team members
- Oversee clinical studies as the company’s medical expert; oversee the analysis and interpretation of clinical study data and the reporting of clinical study results
- Identify and manage value-add clinical and medical activities pertaining to market access, including support from payers, medical societies, foundations, etc.
- Lead DermaSensor’s Scientific Advisory Board and other stakeholders to position the company for strong market acceptance and adoption
- Identify and establish relationships with leading KOL’s and principal investigators, including organising and running KOL meetings, Investigator meetings, and Advisory Boards (Focus Groups), as needed
- Propose and be accountable for clinical development and medical affairs department budgets and contracts, inclusive of team members and vendors (e.g. biostatistics, CROs)
- Support the leadership team in their commercial and business development efforts, e.g. presenting to physicians and administrators at health systems and payers
- Develop and substantiate claims based on reliable scientific evidence to be used in brand messaging, advertising and other promotional material (i.e. data interpretation, extrapolations from publications, internal analyses, etc.) and clinically assess the competitive landscape
- Lead the refinement of medical affairs strategy for commercial markets, along with supporting their implementation. Both directly and with your direct reports, serve as the company medical/scientific guide on the development of product launches, claims, regulatory listings/clearances, and point of view/public relations statements
- Collaborate with internal and external experts for publication planning and coordination with author groups to prepare, review and edit manuscripts for journal submission
- Co-manage with Regulatory the writing and implementation of clinical regulatory interactions (e.g. FDA presubmission meetings) and reports (e.g. clinical study reports)
ABOUT YOU
- MD, DO, or PhD with experience in dermatology and/or primary care clinical settings (preference for board certification in family medicine, internal medicine, or dermatology)
- At least 5 years of clinical research industry experience, preferred expertise with postmarket studies and real-world evidence generation and least 2 years’ experience in medical affairs leadership in device, diagnostic and/or biopharma companies - with products in dermatology, primary care, and/or public health, preferably for skin cancer
- Based in or willing to relocate to South Florida (i.e. commuting distance to Miami, FL)
- Experience in designing and overseeing pre-market and post-market clinical studies
- Experience with analyzing and writing medical literature and/or managing others in doing this
- Experience with supporting market access and reimbursement
- Passion for building innovative, life-saving products; measuring your own success in terms of the success of the product and real-world impact
- Significant team building and leadership experience, including direct reports that have their own direct reports (i.e. manager of managers)
- Familiarity with healthcare systems and their objectives and decision-making
- High attention to detail, ability to manage multiple, competing priorities simultaneously
- Strategic acumen with strong research abilities; able to define complex problems and creatively frame solutions
- Collaborative, team-first attitude – value ideas on their merits to maximize team results
- Ability to collaborate with team members under pressure and iterate quickly, especially in remote settings
- Superior verbal and written communication skills
- Ability to travel an average of 40% of the time, mostly in the US (occasionally ex-US)