Clinical Trial Lead - China

Overview

Clinical Trial Lead

Reports to Senior Director, Regional Head APAC, Clinical Operations

Opportunity

The Clinical Trial Lead (CTL) is responsible for leading the planning, execution, and oversight of designated clinical studies from initiation through study closure. This role ensures all study activities comply with quality standards, regulatory requirements, timelines, and budget commitments. You will serve as the primary point of contact for cross-functional teams and vendors, ensuring the successful delivery of all study life cycle deliverables.

Responsibilities

• Study Management & Oversight: Lead the global cross-functional Clinical Trial Team (CTT), developing agendas and chairing meetings.
• Document Development: Independently develop study-related documents, including protocols, study manuals, project plans, tracking tools, and informed consent templates.
• Vendor Management: Develop clinical outsourcing specifications, facilitate the CRO selection process, manage interfaces with vendors, and ensure all work meets quality standards.
• Clinical Operations: Oversee study start-up efforts, including feasibility, site selection, and the preparation of regulatory packages.
• Quality & Compliance: Maintain the electronic Trial Master File (eTMF), participate in periodic reviews, and respond to Quality Assurance or regulatory authority audits to ensure inspection readiness.
• Financial Oversight: Support the Clinical Program Lead with trial-level budget development, tracking, invoice approval, and annual budget reviews.
• Data & Clinical Support: Act as a key contributor to the Data Review Plan, managing data flow and cleaning processes.
• Mentorship: Provide guidance and mentorship to Clinical Trial Managers and Clinical Trial Assistants; may serve as a line manager for CTAs.

Qualifications

Experience & Technical Requirements

• Education: BA/BS or equivalent degree in a relevant discipline (scientific or health-related background preferred).
• Experience (Mandatory): Minimum of 4–6 years of clinical research experience with a sponsor company or CRO, specifically within oncology/hematology.
• Clinical Development: Advanced understanding of clinical development across Phase I, II, and III trials.
• Regulatory Knowledge: Excellent knowledge of ICH/GCP and FDA-CFR standards.
• Project Management: Proven ability to independently manage activities for multiple clinical studies simultaneously.

Soft Skills

• Communication: Ability to communicate effectively across diverse teams and stakeholders.
• Scientific Agility: Learning agility to quickly develop a sound working knowledge of new therapeutic areas.
• Collaboration: Strong ability to collaborate with other departments to meet study goals and timelines.
• Problem Solving: Acts as a point of contact for issue escalation and the creation of mitigation plans.

Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees

The Menarini Group: Innovation, Ethics, and Global Impact

Founded in 1886 and headquartered in Florence, Italy, the Menarini Group is a leading international pharmaceutical company dedicated to providing high-quality therapeutics and advanced diagnostics for patients globally.

Our foundation is built upon four key pillars: People Care, Patient Focus, Quality, Responsibility & Integrity

Key Facts

• Global Reach: Present in 70 countries, with products sold in 140 locations worldwide.
• Team: Around 18,000 employees globally.
• Manufacturing: 18 manufacturing sites across 6 continents, producing over 500 million packs of drugs annually.

Our Focus on Oncology

Menarini has made a strong, strategic commitment to Oncology, combining innovative therapeutic solutions with advanced liquid biopsy-based diagnostics to drive faster, more effective, and precise patient management.

Our oncology portfolio has been significantly strengthened through the acquisition of Stemline Therapeutics and key licensing agreements, marking our entry into the U.S. oncology market and expanding our presence in Europe and beyond.

Key examples of our cutting-edge work include:

• Targeted Therapies: Developing first-in-class targeted therapies for rare hematological cancers, including a treatment for blastic plasmacytoid dendritic cell neoplasm (BPDCN), and licensed oral agents for hematologic cancers and solid tumors, such as a first-in-class Selective Inhibitor of Nuclear export compound (for which we hold commercialization rights in Europe).
• Endocrine Therapies: Advancing late-stage oral therapies, like a Selective Estrogen Receptor Degrader (SERD), for the treatment of hormone receptor-positive advanced breast cancer.
• Advanced Diagnostics: Our affiliate, Menarini Silicon Biosystems (MSB), is a pioneer in rare cell analysis and non-invasive diagnostics. Their Circulating Tumour Cell (CTC) Test is the only FDA-cleared blood test for detecting and counting CTCs in certain metastatic cancers.

This is an exciting time of growth and development for the company. We invite talented individuals to join us in shaping and building the future of the Menarini Stemline Oncology business.