Director / VP, Clinical Evidence

MyOme•Menlo Park, CA

44d•$170,000 - $250,000•Hybrid

About The Position

MyOme’s mission is to provide clinically actionable genetic information to patients throughout their lives. We combine clinical-grade whole genome sequencing, advanced AI methods for genome interpretation, and seamless digital tools for doctors and patients to order and access results. Our team is composed of seasoned entrepreneurs, scientists, and operators, and we're backed by top-tier investors. This position drives direction and leadership for clinical development of several large-scale multi-site prospective trials (including one that is 50K+), which will transform healthcare. You will be accountable for the execution and aspects of design of our clinical evidence strategy, including protocol design, operationalizing the effort, and leading FDA interactions that relate to clinical utility.

Requirements

Medical degree (M.D. or D.O.) with at least 5 years of clinical experience preferred or PhD with extensive trial experience
Proven experience in clinical trial leadership, including collaboration with academic institutions, research networks, and industry partners.
Strong understanding of clinical operations, regulatory requirements (e.g. FDA), and trial design principles (pharma, device, diagnostics)
Demonstrated ability to build wide and effective networks of contacts inside and outside the organization, across a diverse spectrum of people
Comfortable operating in a fast-moving environment, balancing strategic oversight with hands-on execution.
Open-minded and adaptable, willing to roll up your sleeves and contribute wherever needed to move programs forward.

Responsibilities

Develop and lead clinical strategy to advance company goals and evidence generation, including regulatory and reimbursement efforts.
Design and implement clinical trials, incorporating input from key opinion leaders and the clinical advisory board to optimize study interventions and endpoints.
Navigate FDA and other regulatory bodies to ensure compliance and successful study execution.
Operationalize trials through contracting, budgeting with large health organizations, and CROs.
Partner with internal teams (e.g., R&D) and consultants to ensure studies are appropriately powered and aligned with overall development strategy.
Provide clinical oversight and medical monitoring for ongoing studies.
Analyze and interpret clinical data, integrating findings into product development plans and regulatory submissions.
Represent the organization in external meetings with investigators, regulators, and collaborators as a clinical subject matter expert.