Job Description
Job Title: Senior Director, Clinical Operations
Avirmax Biopharma, Inc. (ABI) based in San Francisco Bay Area, is a preclinical stage biopharmaceutical company focusing on innovation and development of genetic medicines to treat chronic and degenerated ocular diseases using integrated solutions in engineering and optimization of adeno-associated virus (AAV) vectors, rich experience and knowledge in biopharmaceutical development and product supply. Our mission is to deliver patients with safe, effective, durable, affordable and accessible AAV-mediated biotherapeutics to preserve patient’s vision.
Job Description:
We are seeking a highly experienced Senior Director, Clinical Operations to be a part of our rapidly growing team at Avirmax. The Senior Director will lead cross functional teams, including internal and third party, to drive clinical development activities for the CRO/CDMO. This position will use project management methodologies and best practices to help deliver projects on time and within budget, including establishment of SOPs
Responsibilities:(including, but not limited to):
- Leading clinical teams, project and trial planning, budgeting and financial oversight, staff and contract research organization (CRO) management, program/trial clinical operation, timelines and GCP compliance
· Plan and implement projects, help define project scope, goals, deliverables; and define tasks and required resources.
- Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices.
- Collaborate closely with the key stakeholders of the project.
- Review master service agreements, statements of work, and quality agreements relating to clinical operations
- Manage budget, allocate project resources, create schedule and project timeline, track deliverables and monitor and report on project progress.
- Plan clinical headcount and hiring needs to meet program workload demands.
- Maintain Shared File System and other databases with project status and key project information.
- Participate in developing and providing input to protocols, annual safety reports, clinical study reports, publications/presentations and regulatory submissions
- Contribute to internal process improvement initiatives, especially those involving tools and knowledge management solutions.
Requirements:
- 5-10 years applicable experience in clinical operations in ophthalmology pharma/biotech industry.
- Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and regulatory components is essential
- A thorough understanding of drug development from IND to NDA
· Knowledge and experience with developing, negotiating and managing contracts (vendor and site)
- Regulatory inspection experience
- Strong working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices
- Strong communication, organizational and interpersonal skills are necessary for this role
- Ability to work in a fast-paced environment with a sense of urgency and handle multiple roles.
Education:
- Minimum of Bachelor's degree or Master’s degree in Business Administration, or related field.
Job Location: Bay Area.
Job Type: Full-time.
Work authorization: work authorization in US is required.
About the Benefits:
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs including awards and stock option plans. Additionally, Avirmax Biopharma Inc. offers all team members a comprehensive benefits program including medical and dental insurance, 401(k), paid vacation and holiday time.
Avirmax Biopharma Inc. is an equal opportunity employer (EOE/AA)
Job Type: Full-time
Pay: From $120,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Paid time off
- Parental leave
Schedule:
Supplemental pay types:
Work Location: Hybrid remote in Hayward, CA