Associate Director/Director, Clinical Operations, Autoimmune

Remegen Biosciences, Inc.; United States; Remote; USD 90,000 - 160,000; Full time

Job description

Associate Director/Director, Clinical Operations, Autoimmune

RemeGen Biosciences is a biopharmaceutical company focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen Co., Ltd, a global pharmaceutical company specialized in autoimmune, oncology, and ophthalmic diseases.

POSITION SUMMARY

The Director of Clinical Operations responsibilities include managing CRO and other external vendors, collaborating with cross-functional teams, ensuring study strategy is incorporated into the execution of each study, and that studies are executed on-time, on-budget, and in compliance with FDA, EMA & ICH guidelines, SOPs, local regulations, etc. This position requires a high-performing contributor with strong business acumen and leadership skills. This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This is a remote role open to candidates in Massachusetts, Pennsylvania, New Jersey, Florida, California, and Texas.

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.
• All other duties as assigned.

REQUIREMENTS

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 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 HIPAA 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
• Paid time off/vacation/sick time
• Referral program

RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, 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 the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.

Must be able to work legally in the United States without sponsorship from the employer.