Clinical Trial Manager, Global Clinical Development

RemeGen is a global biopharmaceutical company with headquarter in China and offices in San Francisco and Maryland in the United States. RemeGen is committed to the discovery, development, and commercialization of innovative and differentiated biologics to address major unmet medical needs. We have rich pipelines in Autoimmune, Oncology and Ophthalmology. Disitamab Vedotin (RC48) was approved to treat gastric and urothelial cancers in China and global Phase 3 clinical trials are in planning in partnership with SeaGen. Additional molecules are either in the clinical stage of development or entering to clinical in various Oncology indications. RC28 and other molecules are in clinical development in Ophthalmology diseases. Telitacicept (RC18) is our lead molecule in the Autoimmune diseases area. 

Telitacicept is a first-in-class TACI-Fc fusion protein that targets both B-cell lymphocyte stimulator (BLyS) and A Proliferation Inducing Ligand (APRIL). Telitacicept was approved in China for SLE in 2021 based on the Phase 2 clinical trial results and received FDA fast-track status for development in SLE. Results from the Phase 3 clinical trial conducted in China, which was presented at ACR in November 2022, demonstrated consistent results, with a statistically significant treatment effect of SRI-4 response rate of 67.1% for RC18 vs. 32.7% for placebo (missing data imputed as non-responders). Other major milestones of Telitacicept include the Phase 2 and 3 clinical trials in China for Rheumatoid Arthritis, Primary Sjogren’s Syndrome, Myasthenia Gravis (MG), Lupus Nephritis, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder, and IgA Nephropathy in China and US. In addition, we have received FDA orphan designation and fast-track status for MG global development.

We are looking for motivated Sr. Director, Global Clinical Operations to join our growing global clinical development team.  Salary: $100,000.00 to $140,000.00.

Clinical Trial Manager, Global Clinical Development

Location: SF/MD/Remote

Responsibilities:

• Responsible for global clinical trial execution in compliance with ICH/GCP, SOP, regulatory, global and local guidelines.
• Provide oversight to cross functional partners at CRO and other external vendors to ensure quality execution of the clinical trials within timeline and budget.
• Proactively manage trial start up activities in collaboration with CRO, including feasibility, country/site selection, site contract and budget negotiation, database and lab set up, study plans, training requirements, etc.
• Work with cross functional team and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support regulatory submissions.
• Keen attention to program and study statuses and proactively communicate issues or changes that may impact quality, timelines, and costs to senior management and key stakeholders
• Work closely with CROs and internal team to ensure patient recruitment and retention.
• Develop and maintain strong relationships with internal cross-functional teams, CROs, and clinical research site personnel to ensure effective execution of clinical trials
• Plan and implement quality checks for multiple clinical trials (e.g., establish and review key performance indicators, metrics, and progress reports, identify barriers to timely and successful trial execution)
• Provide clinical operational input to protocol, ICF, safety and other relevant clinical trial key documents and plans.  
• Drive and support the development of work instructions and SOPs; contribute to Clinical Operations functional initiatives for role clarity and institution of best practices
• Other tasks as required.

• Travel: Up to 10% as needed.

Qualifications:

• Bachelor of Science or equivalent degree.
• 5+ years of experience of global clinical trial operation in biopharmaceutical companies.
• Experience in global phase 2-3 clinical trials in autoimmune diseases is strongly preferred.

• Successful track record in study planning, country/site selection and activation, patient recruitment and retention, data cleaning, and data base lock.
• Excellent leadership, strong organizational, communication and interpersonal skills are required.
• Well organized and ability to handle multiple tasks and prioritize urgent tasks.

POSITION TYPE

• Full-time position in our South San Francisco or Maryland office preferred, open to remote.

WORK AUTHORIZATION

• Candidate must be legally eligible to work in the US.

AAP/EEO STATEMENT

• Remegen Biosciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.

OTHER DUTIES

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

BENEFITS

• 401(k) 401(k) matching Medical Insurance Dental insurance Vision Insurance Flexible spending account Health savings account Life insurance