Sr Director, Clinical Strategy

GeneDx•Gaithersburg, MD

9h•$240,000 - $260,000•Remote

About The Position

The Senior Director of Clinical Affairs will lead high-impact programs that advance GeneDx’s mission in rare disease diagnostics and precision medicine. This role is responsible for driving strategic initiatives within the Clinical Development team, including clinical research programs, medical input on product development, and regulatory support. The position requires strong leadership, deep expertise in clinical molecular genetics, and the ability to collaborate across internal teams and external stakeholders, including clinicians, academic collaborators, key opinion leaders (KOLs), and biopharma partners.

Requirements

PhD, MD (or equivalent) with board certification by the American Board of Medical Genetics and Genomics (or equivalent) required
10+ years of experience in a clinical laboratory or industry role as a board certified ABMGG fellow required
5+ years of experience in a medical affairs role required
5+ years of experience leading research efforts related to molecular diagnostics in rare disease required
Strong level of clinical genetics knowledge in rare disease
Strong publication record
Ability to work cross-functionally with other teams and external collaborators to drive strategic initiatives forward
Excellent written and verbal communication skills
Exceptional presentation and public speaking skills
Ability to work independently and manage time effectively
Detail-oriented with strong organizational skills
Proven experience leading teams and managing cross-functional collaborators to deliver on goals of projects and programs
Proficient in working with databases and Microsoft Office Suite.
Certification by the American Board of Medical Genetics and Genomics (ABMGG) or equivalent in clinical molecular genetics or laboratory genetics and genomics (LGG)

Nice To Haves

Experience working with rare disease biopharma preferred
Experienced in solving complex problems and negotiating business deals.

Responsibilities

Evidence Generation Strategy: Support the design and execution of evidence generation strategies for established clinical programs that cover clinical settings and diseases/disorders of interest in collaboration with R&D, Commercial, Regulatory, Market Access, and Operations teams. Spearhead strategic initiatives within Medical Affairs to support GeneDx’s growth and innovation goals.
Design and Execution of Internal Clinical & Translational Research: Lead and oversee clinical research projects that utilize internal GeneDx data and align with established clinical programs. This includes the direct development and execution of projects within assigned clinical programs as well as oversight of studies that fall within other clinical programs managed by a team of clinical program managers. Collaborate with internal partners, including clinical data scientists, health economics and outcomes researchers (HEOR), and Product, to design and execute projects. Project oversight includes ensuring strategic alignment of internal research projects with the broader evidence generation strategy, prioritization, resource allocation, and regular reporting to Medical Affairs/Clinical Development leadership as well as leading applicable study meetings.
Collaborations and Partnerships: Partner with internal and external stakeholders on prospective clinical and translational research efforts aligned with established clinical programs to deliver on project and program objectives. Identify and establish strategic collaborations with academic institutions, research organizations, and key opinion leaders (KOLs). Manage relationships with external partners to drive collaborative research projects, including clinicians, KOLs, and other strategic partners. Collaborate with internal partners, including Clinical Research Operations and Legal, to support contracting and project execution. Direct cross functional research project teams with internal and/or external interest holders, providing expert guidance and fostering a collaborative environment.
Publication Management: Oversee the development, review, and submission of scientific manuscripts, abstracts, posters, and other publications aligned with established clinical programs. Collaborate with internal and external authors to produce high-quality scientific content. Acts as a subject matter expert for rare diseases and genomic diagnostics (including inpatient and outpatient testing, screening indications, and other clinical settings or indications of interest) for both internal teams and external stakeholders. Represent GeneDx at scientific conferences, clinical meetings, and other industry events. Deliver high quality presentations on GeneDx research and quality standards. Provide medical support internally for medical, product, and commercial strategy as well as scientific messaging. Provide medical support as needed for FDA and other regulatory submissions. Solve complex problems and lead innovative solutions that drive organizational success. Provide mentorship and guidance to team members, fostering a high-performance culture.
Lead Team of Clinical Program Managers: Lead and mentor clinical program managers, including resource allocation, coaching and performance feedback, career development support. Foster a collaborative, high-performing team culture.