Clinical Operations Lead for Autoimmune Therapies
1 day ago
RemeGen Biosciences, Inc. is a pioneering biopharmaceutical company dedicated to the discovery and development of innovative treatments for cancer and autoimmune diseases. With a strong focus on leveraging cutting-edge technologies and expertise in oncology and immunology, we strive to create novel therapeutic solutions for patients with significant unmet medical needs.
Located in South San Francisco, California, and Rockville, Maryland, our organization operates as a wholly owned subsidiary of RemeGen Co., Ltd., a global pharmaceutical company specializing in autoimmune, oncology, and ophthalmic diseases.
Job SummaryWe are seeking an experienced Clinical Operations Lead to manage global clinical trial execution in compliance with ICH/GCP, SOP, regulatory, global and local guidelines. The successful candidate will have a proven track record of leading cross-functional teams and collaborating with external vendors to deliver high-quality clinical trials within budget and on time.
Key Responsibilities:- Responsible for global clinical trial execution in compliance with ICH/GCP, SOP, regulatory, global and local guidelines.
- Participate in the CRO selection process and negotiate master service agreements, scope of work contracts, change orders, etc.
- Proactively manage trial start up activities in collaboration with CRO, including feasibility, country/site selection, site contract and budget negotiation, database and lab setup, study plans, training requirements, etc.
- Work with cross-functional teams 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.
- Manage CRO and other external partners and collaborate with internal cross functional teams to ensure operational delivery of the assigned 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.
- Support the manager to lead clinical operation activities including feasibility, country selection, regulatory and ethic submissions, site startup, operational input to the study design, risk-based quality management.
- Prepare clinical trial documents, e.g., project plans, communication plans, clinical trial management plan, site selection, SIV, patient recruitment and retention plan, etc.
- Effectively communicate regular clinical trial updates to management on clinical trial progress, performance, risks and mitigation strategies.
- Bachelor of Science or equivalent degree, required.
- Master of Science/Advanced degree preferred.
- The annual base salary for this position ranges from $180,000 to $240,000, making it an attractive opportunity for professionals seeking a challenging and rewarding career in clinical operations.
- A comprehensive benefits package, including 401(k) and matching program, medical, vision, and dental insurance, flexible spending account, short- and long-term disability, life insurance, employee assistance program, employee discounts, paid time off/vacation/sick time, professional development assistance, and referral program.
RemeGen Biosciences, Inc. is an equal opportunity employer and welcomes applications from qualified individuals regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran's status, or any other characteristic protected by law. Must be able to work legally in the United States without sponsorship from the employer.
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