Clinical Trial Manager

MEDIPOST, Inc.; United States; On-site; USD 140,000 - 150,000; Full time

Job summary

MEDIPOST, Inc. is seeking a Clinical Trial Manager to lead a pivotal global Phase III trial for CARTISTEM, a novel stem cell therapy for knee osteoarthritis. This full-time role involves overseeing complex clinical operations, managing cross-functional teams, and ensuring regulatory compliance, offering a unique opportunity to impact the healthcare sector significantly.

Benefits

Medical insurance

Vision insurance

401(k)

Disability insurance

Qualifications

• 7+ years of clinical trial experience, with at least 3 years as a CTM.
• Experience in large Pharma and small Biotech environments.
• Hands-on BLA or NDA submission experience.

Responsibilities

• Own clinical trial execution from start-up through database lock.
• Oversee vendor relationships and ensure compliance with KPIs.
• Drive regulatory readiness activities and contribute to key BLA documents.

Skills

Clinical trial regulations

GCP

ICH guidelines

Communication

Leadership

Education

Bachelor's degree or higher in a related field

Tools

EDC

TMF

CTMS

Job description

This range is provided by MEDIPOST, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$140,000.00/yr - $150,000.00/yr

About MEDIPOST:

Not only is MEDIPOST the most trusted and largest umbilical cord blood bank in Korea, but we are a commercial-stage cell therapy company developing novel umbilical cord-derived stem cell therapies to treat inflammation-driven degenerative diseases such as Alzheimer’s, Diabetic Neuropathy, and Osteoarthritis across the globe.

Our lead product, CARTISTEM, is the world’s first allogenic stem cell therapy and treats patients suffering from moderate to severe knee Osteoarthritis (OA). Approved in Korea in 2012, we have treated over 28,000 patients to date. MEDIPOST has recently formed a joint venture with the Centre for the Commercialization of Regenerative Medicine (CCRM) to form OmniaBio, a cell and gene therapy contract and development organization (CDMO) in Toronto. Leveraging our in-depth scientific and stem cell therapy development expertise, our 10 years of commercial and clinical experience with CARTISTEM, and our CDMO joint venture, OmniaBio, we now have a developing Phase III clinical program to expand CARTISTEM into the North American and European markets.

As MEDIPOST embarks on a journey to halt degenerative diseases such as osteoarthritis, we are seeking a talented, highly experienced Clinical Trial Manager (CTM) to lead a pivotal, global Phase III trial supporting the BLA submission of CARTISTEM, a novel allogeneic stem cell therapy for knee osteoarthritis. This position offers the opportunity to oversee complex clinical operations across global regions, manage cross-functional teams, and contribute directly to regulatory submissions. The ideal person is someone who has worked on a large, complex BLA Phase III trial (maybe at a large Pharma company), so they know the scale of work involved, and then moved to a small biotech and is used to working in an agile, fast-paced environment with scarce resources. In joining MEDIPOST, you will have a challenging and fulfilling role at the forefront of an industry revolutionizing the healthcare sector.

Responsibilities

• Own clinical trial execution from start-up through database lock for a global Phase III trial involving many sites (typically over 30 sites)
• Oversee vendor relationships, including CROs, laboratories, and supply chain providers; ensure compliance with KPIs and timelines
• Drive regulatory readiness activities such as TMF completeness, protocol adherence, and pre-inspection audits
• Contribute to the development of key BLA documents, including CTD modules, ISS/ISE summaries, and clinical study reports
• Collaborate across functions with medical, data management, safety, regulatory, and supply chain teams to ensure operational alignment
• Lead site training initiatives, covering intraoperative procedure education and device handling workflows
• Support senior leadership in program planning, resource allocation, and risk mitigation.

Key Requirements

• 7+ years of progressive clinical trial experience, with at least 3 years as a CTM leading global Phase III trials with at least 30 sites or more
• Most have big Pharma and small Biotech industry experience
• Hands-on BLA or NDA submission experience, including direct involvement in regulatory meetings, document preparation, and inspection readiness
• In-depth knowledge of clinical trial regulations, GCP, and ICH guidelines.
• Strong experience with biologics, preferably allogeneic stem cell therapies or regenerative medicine products
• Experience with surgical device trials, ideally involving orthopedic procedures (e.g., joint implants, drills, intraoperative workflows)
• Demonstrated ability to manage CROs, vendors, and clinical systems (EDC, TMF, CTMS) across U.S., EU, and APAC regions
• Track record of success in both large pharma (for scale exposure) and small biotech environments (for agility and accountability)
• Excellent communication and leadership skills, with the ability to prioritize, escalate, and maintain operational quality under pressure

This is a full-time, field-based role. Candidates must be eligible to work in the United States and comfortable with 20–30% travel.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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