Senior Director, Clinical Operations

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:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Work Location: Hybrid remote in Hayward, CA