About the position
The Director of Medical Affairs is accountable for the development, execution and oversight of research, medical and scientific strategies for Miro’s digital brain health products.
As the Director of Medical Affairs, you will be responsible for directing clinical programs and shaping evidence generation to advance Miro’s scientific and economic programs. The Executive Medical Affairs Director is expected to maintain a comprehensive understanding of relevant clinical and payer issues, while ensuring that Miro’s partners understand fundamental opportunities to influence outcome-based care delivery in the broader healthcare marketplace.
With an aim of generating and communicating medical evidence that helps practitioners, patients, and payers make good health care decisions, the successful candidate exhibits outstanding communication and leadership skills and builds strong relationships with key stakeholders in the clinical community. In this role, you will be responsible for interfacing with Primary Investigators, research staff, and policy experts to develop, refine, and communicate foundational findings and evidence to support Miro’s value-based care initiatives across multiple areas of neurology, psychiatry, and neuropsychology. This position actively maintains a network of clinical and scientific experts and performs a variety of medical activities, as needed. This role serves as the guardian for high standards of compliance, ethics and safety.
The ideal candidate has experience overseeing clinical programs, communicating clinical metrics and results, and influencing clinicians and key opinion leaders to drive uptake in research and healthcare. A record of accomplishments in clinical psychology or neurology, deep subject-area knowledge, ability to build senior investigator relationships, and experience launching new products in an entrepreneurial environment is a strong plus.
Drive and oversee the development and execution of strategic medical plans for all clinical programs.
Provide scientific and clinical expertise to develop and approve study synopsis, protocols and study reports, including health economic and outcomes research-related studies, utilizing clear understanding of the regulatory policy landscape; develop and implement appropriate outcomes- and quality-based study metrics
Proactively assess the external healthcare delivery environment perspectives that shape product medical strategies
Plan and execute clinical study design, including management of data collection via various endpoints for multiple FDA submissions and claims; work with partners and regulatory
Write or revise grant applications, study protocols and IRB submissions
Oversee study operations, evidence capture, publications and communications
Craft regular data-review and reporting protocols both for trial management and to support product improvement; identify and prioritize product features to support rapid marketplace adoption
Lead engagement and recruitments efforts with academic and industry collaborators
Review and approve scientific results and communications
Ensure Miro’s ongoing compliance and legal processes in accordance with ICH-GCP, FDA and ISO standards.
Interview, hire, manage and train supporting staff as appropriate
Advanced Clinical Degree Required (e.g. MD, PsyD, PhD, etc.) with experience in neuropsychology or neurology preferred
Minimum 5-8 years of relevant clinical / academic, medical /biotechnology industry experience
Experience or relevant knowledge of pre-approval drug development trials and/or post-marketing medical evidence generation, including expertise in controlled and observational study designs, data analysis, and clinical/health economic interpretations
Understanding health economics, health and insurance policy, evidence-based medicine tools and practices, and health technology assessments
Proven expertise with a wide range of data/information including scientific/clinical, safety, legal/regulatory, medical writing, and analytics
Ability to navigate complex and challenging situations, prioritize and maintain focus
Strong background of regulatory requirements governing clinical and evidence-based studies (HIPAA, GCP, FDA, CMS)
Familiarity with preparation and submission of 510ks or de Novo applications to FDA
Familiarity with FDA and CMS regulatory processes; ability to collaborate with external advisors to prepare submission materials
Proven organizational efficiency, planning and execution skills
Flexible and adaptable to the needs of a young, mission-driven company
Qualities that will bring success to this role
PsyD or PhD in neuropsychology or MD in neurology
Demonstrated success with regulatory submissions and approvals
A roll-up-your-sleeves, get-it-done work style
Exceptional communication, influencing, and project management skills
Detail-oriented with a tendency to think 10-steps ahead
Comfortable with ambiguity and shifting priorities
Ability to foster and maintain close relationships with a broad range of people
ACRP or CCRP Certification by SoCRA a plus
Competitive salary, equity, healthcare coverage, flexible hours and vacation