Job Title: Antibody Drug Conjugate, ADC Medical Monitor

About us:

Henlius is an international innovative biopharmaceutical company committed to providing affordable and high-quality biopharmaceuticals to patients around the world, covering oncology, autoimmune diseases, ophthalmic diseases, and other fields, with 5 products on the market in China and 2 products in the world, 19 indications approved, and 7 marketing applications accepted by the China Food and Drug Administration, the US FDA and the EU EMA.

POSITION SUMMARY:

Draft Clinical Trial Protocols; medical monitoring of the clinical trials for new drugs and medical communication with the required departments. This is a home-based position.

Clinical Trial Protocol:

-Responsible for drafting and revising clinical trial protocols

-Communicate with clinical medical experts and registration authorities on the design of clinical trials according to the needs of clinical projects

-The protocol includes selection of indications, design of clinical trial, consultation on documentation required by register authorities (trial protocol, summary report) etc.

Implementation of Clinical Medical Monitor:

- Medical monitor of clinical trials

Including: communication and training on professional knowledge within and outside departments, formulation of medical monitoring plans (eligibility criteria verification/protocol deviations/database verification, etc.).

- Medical communication & problem solving

Communicate with investigators and SMT to solve medical related problems in the clinical trial.

- Medical support

Cooperate with other departments to provide professional medical advice.

Prepare medical registration application materials.

QUALIFICATIONS:

Education:

Doctor of Medicine degree, PhD with a strong scientific background and major in life sciences or related field required.

Experience:

1. At least 10 years of pharmaceutical industry experience

2. Experience with all aspects of designing, executing, monitoring, and managing clinical trials from inception to completion across all phases of development

3. Familiar with new drug development process and ADC clinical trials from Stage I to Stage III with experience in clinical monitoring

Skills:

1. Communication skills (written and verbal), which are equally effective internally and externally

2. Excellent planning, and execution skills

3. Competency with all MS Office Products, including PowerPoint and Strong Excel Skills

Competency:

1. Ability to multi-task and manage several projects in parallel

2. Ability to forge cross-functional working relationships with internal teams and external project partners, and work in a collaborative manner

3. Expert knowledge of Good Clinical Practice (GCP)

4. Strong knowledge of FDA and ICH regulations

Other requirements:

Travel frequency: about 10% of the time

Key Performance Indicators:

Protocol completion and timeline

Qualification rate of protocol quality assessment

Training coverage

Eligibility criteria verification/protocol deviations/database verification

Project support satisfaction

Researcher's satisfaction with cooperation

Henlius USA Inc.

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ADC Medical Monitor (Antibody Drug Conjugate)