Clinical Operations Director
3 days ago
RemeGen Biosciences, Inc. is a biopharmaceutical company dedicated to discovering and developing innovative medicines for the treatment of cancer and autoimmune diseases. We are seeking a highly skilled and experienced Clinical Operations Director to join our team.
Key Responsibilities- Manage 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.
- All other duties as assigned.
Education:
- Bachelor of Science or equivalent degree, required.
- Master of Science/Advanced degree preferred.
Experience:
- 10+ years of increasing leadership responsibilities in clinical operations in a pharmaceutical, biotech or CRO company.
- In-depth knowledge of clinical operations and pharmaceutical drug development process in a pharmaceutical or biotech company in the Autoimmune Therapeutic area, preferred.
- Proven ability to lead a team, supervise CRO, and collaborate with cross-functional teams to deliver global clinical trials with high quality, within budget and on-time.
- Thorough understanding of FDA, EMA, and HIPPAA clinical research regulatory requirements, good clinical practices, project management and data handling.
Skills:
- Excellent written and verbal communication skills.
- Ability to work cross-functionally in a fast-paced, collaborative environment.
- Strong attention to detail and problem-solving skills.
Benefits:
- 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
- Referral program
RemeGen Biosciences, Inc. is an Equal Opportunity Employer. We adhere to and promote equal employment opportunity (EEO) for all.
Must be able to work legally in the United States without sponsorship from employer.
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