Senior Director, Clinical Operations
Huyabio International is a development-stage biopharmaceutical company bringing innovations from China to global markets in multiple therapeutic areas. HUYABIO’s lead oncology compound, HBI-8000, is under regulatory review for marketing approval in Japan and Korea for the treatment of T-cell lymphoma. In the United States, HBI-8000 is being developed as an immune modulator in combination with checkpoint inhibitors. The Company’s lead cardiovascular program, HBI-3000, is in Phase 1/2 development in Australia/New Zealand. Two additional compounds are in IND enabling stage. More information can be found at www.huyabio.com
To expand our clinical development programs, HUYABIO is seeking a self-motivated individual to take a leadership position in a fast-paced environment as Senior Director, Clinical Operations.
This position reports to HUYABIO’s Head of Clinical Operations with a dotted line to the CMO. Responsibilities include oversight of clinical studies, from trial start up and implementation (e.g., enrollment) including managing external support such as vendors. Responsibilities include, but not limited to study planning, budgeting, and financial oversight, vendor/partner management, monitoring study and program timelines, and regulatory and quality compliance. This position works in a cross-functional environment. He or she will contribute to corporate goals to achieve business objectives.
This is an office-based position with occasional business travels. Clear, timely, professional, and effective communication with collaborating functional areas and office sites is essential.
Primary Duties and Responsibilities
- Actively contributes (such as drafting, authoring) to protocol development, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports, and other study related documents such as pharmacy manual, patient sample management procedures., Review and edit study documents, if developed by vendors/partners.
- Responsible for the development of, and the oversight for, clinical study milestones to meet program objectives.
- Supervise, when applicable, the clinical operations staff to ensure quality deliverables and meeting timelines. Coaching and mentoring as needed to ensure accountability.
- Effectively communicate the status, progress and issues related to clinical programs/studies. Identify risks, impediments, and proactive develop mitigation plans.
- Provides study matrix e.g., data entry into database, outstand data queries, enrollment census (screen failure, treated, evaluable subject numbers) against accrual targets and mitigation actions as needed.
- Ensures that clinical studies follow guidelines and necessary processes and procedures, as applicable (e.g., Code of Federal Regulations, ICH Guidelines and Good Clinical Practices, FDA, EMA, PMDA) and appropriate industry standards. Works with Quality and is responsible for the development of SOPs and operational compliance.
- Work effectively through communication and process development to ensure team work with biostatistics, data management, CMC/drug supply, medical writing, regulatory, finance, and legal, as applicable.
- Ensures audit readiness at all times.
- Take ownership and be accountable for Vendor contract, scope of work, budget development and negotiation, payment terms to ensure cost efficiency, and consistency with business objectives.
- Creates a positive and productive work environment with highly qualified and motivated clinical professionals.
- Perform other duties as required.
Job Qualifications and Requirements
- Pharmaceutical, biotechnology, or clinical research experience for a minimum of 8 years, with more than 5 years in industry on the sponsor side
- Experience in Phase 2 or 3 clinical trials in oncology is a must
- Strong Project Leadership skills with proven record
- Excellent oral and written communication skills in English, including technical writing
- Self-motivated, enjoy hands-on involvement in project, problem solving, is comfortable to work independently
- Willing to share experience with colleagues, and to assist upon request
Education and Experience
- Minimum Bachelor’s Degree in Biological Science or equivalent in allied healthcare, e.g., pharm D and nursing.
- Experience in resource management
- International experience is a plus
The position is full‐time, office-based at HUYABIO’s Del Mar, CA headquarters. Interested candidates should submit resumes to: email@example.com.
To learn more about Huyabio, please visit www.huyabio.com. Huyabio is an equal opportunity employer.