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Vice President of Clinical Operations

Philadelphia, PA, United States

Vice President, Clinical Affairs

About the Company

Venture-backed biotechnology firm innovating the procedural diagnoses of infectious diseases

Industry

Biotechnology

Type

Privately Held, VC-backed

Founded

2014

Employees

51-200

Funding

$200+ million

Categories

Biotechnology

Genetics

Information Technology

Life Science

Big Data

Diagnostics

Specialties

life sciences

diagnostics

genomics

data science

bioinformatics

computational biology

liquid biopsy

next-generation sequencing

cell-free dna

microbiology

machine learning

infectious diseases

global health

clinical care

Business Classifications

B2B

Enterprise

About the Role

The Company is seeking a Vice President of Clinical Affairs to spearhead its clinical operations and development teams. The successful candidate will be responsible for leading all clinical operational aspects of trials, from protocol development to close-out, and will play a pivotal role in the clinical development strategy, including the design of a dynamic roadmap to prioritize clinical indications and accelerate test adoption. This role requires a minimum of a Bachelor's degree in a scientific or clinical field, with a Ph.D. or M.D. preferred, and a minimum of 10 years of clinical management experience, including at least 5 years in hospital, clinical laboratory, and/or life science markets with a proven track record in clinical studies. Experience with Medical Device-IVD, 510K/PMA, and/or lab-developed test diagnostic clinical trials is also preferred. The Vice President will be tasked with maintaining study-related plans and documents, overseeing the departmental budget, and attracting, hiring, and mentoring a high-performing clinical affairs team. Strong leadership and project management skills are essential, as is the ability to work in a cross-functional environment and interact with multiple disciplines. The role also involves managing relationships with key opinion leaders, clinical investigators, and external partners, as well as representing the company in interactions with regulatory agencies and scientific conferences. The ideal candidate will have a deep understanding of human subject research, ICH/GCP guidelines, and FDA/CMS/LDT regulations, and will be a strategic thinker with the ability to execute clinical strategies effectively.

Hiring Manager Title

Chief Medical Officer

Travel Percent

20%

Functions

Medical Care/Hospital Administration

Strategy

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