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Director Medical Affairs
San Francisco, CA
   Clinical Research     Full Time

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.

Responsibilities

  • 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

Requirements

  • 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

Compensation

Competitive salary, equity, healthcare coverage, flexible hours and vacation

*At this time, we are unable to support H1B Visa transfers or applications.