Head of Medical Affairs

Sera Prognostics, Inc. • Full-time • Remote • 1w ago

Head of Medical Affairs Overview

Located on the edge of the beautiful Wasatch Mountains, Sera, Inc. is a women’s health diagnostics company dedicated to improving the health of babies and mothers. We are a growing company tasked with becoming a global leader in high value women’s health diagnostics, delivering pivotal information to physicians that will improve health and improve the economics of healthcare delivery. According to Sera’s CEO, employees here must possess three qualities to be successful: 1) the individual must be passionate and dedicated to changing the world; 2) they must be smart and work smart; and 3) they must have absolute integrity. If this is you, we urge you to keep reading!

At Sera, we’re proud to offer innovative products that meet the needs of our customers. To help us continue expanding our offerings, the Head of Medical Affairs will lead the medical strategy and operations of our portfolio. This role bridges research and development, clinical operations, data science, regulatory affairs, and commercial strategy to ensure the clinical value of Sera’s products is clearly communicated and supported by robust evidence. The Head of Medical Affairs will be a key member of the executive leadership council.

Location

Hybrid with up to 75% travel
Remote

Responsibilities

Medical Strategy & LeadershipDevelop and execute the global medical affairs strategy aligned with corporate goals.
Serve as the internal medical expert, guiding product development and commercialization.
Collaborate cross-functionally with clinical operations, data science, regulatory affairs, and commercial teams.
Responsible for the organization’s medical information in the product portfolio; review and approval of publications, internal policies, procedures and programs.
Interact with CAP, CLIA, NYSDOH, FDA and/or other governmental agencies and accrediting organizations on issues related to patient safety and clinical performance.
Lead and manage medical information and medical science liaison activities, analyze clinical and epidemiological outcomes while serving as clinical scientific peers and resources to foster non-promotional ethical relationships between the organization and medical community.
Participate in internal and external training activities for physicians, ordering providers, and other medical professionals on medical related topics, including testing, clinical adverse events, and epidemiologic studies, while separated from sales and marketing functions.
Clinical Evidence & Research Oversee the design and execution of clinical studies to support product claims and reimbursement.
Support publication planning and ensure dissemination of clinical data through peer- reviewed journals and conferences.
Drive health economics and outcomes research (HEOR) initiatives.
External Engagement Build and maintain relationships with key opinion leaders (KOLs), healthcare professionals, and advocacy groups.
Represent the company at scientific and medical conferences, advisory boards, and regulatory meetings.
Medical Education & Communication Develop and implement medical education programs for internal teams and external stakeholders.
Ensure all medical communications are scientifically accurate and compliant with regulatory standards.
Compliance & Governance Ensure all medical affairs activities comply with applicable laws, regulations, and industry standards.
Provide oversight for medical review of promotional and scientific materials as part of the copy approval team for our laboratory tests and digital products.

Required Qualifications

MD, DO, or PhD in a relevant scientific field; board certification preferred for MDs.
Personal OBGYN/MFM or family practice experience preferred.
10–15+ years of experience in medical affairs, with at least 5 years in a leadership role.
Strong background in women’s health diagnostics, molecular biology, oncology, or related fields.
Proven track record of leading cross-functional teams and managing complex projects.
Excellent communication, leadership, and strategic thinking skills.

Benefits for Full-Time Employees

We offer a competitive salary range for this position, along with annual incentive compensation. It includes an excellent benefits package featuring an 85% to 95% premium-paid healthcare plan, 401K plan, 14 paid holidays, three weeks of paid time off, employee stock options, and more!