Position: Senior Manager/Associate Director, Clinical Operations

Function: Clinical Development and Operations

Company: Phanes Therapeutics, Inc.

Location: San Diego, CA

Phanes Therapeutics is an emerging leader in drug discovery in immuno-oncology and eye disease. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.

At Phanes, we understand that scientific innovation is a challenging task and that’s why we are looking for exceptionally talented people to join us on our mission. We are committed to fostering an innovative and fun working environment where individuals can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people. We offer competitive compensation and excellent medical, dental and vision benefits, and excellent career growth opportunities.

This position is in the clinical development and operations function located at our R&D site in San Diego, CA. The candidate should have solid training and/or broad experiences in clinical operations, especially with regards to the development of oncology therapeutics. The candidate will work with project teams to advance preclinical lead molecules into the clinic and coordinate clinical operation functions in close collaboration with clinical research organizations. In addition, the candidate is expected to be skillful in integrating information from various functions and be articulate in communicating company clinical operations strategy to internal and external stakeholders.

The candidate must be a team player and is expected to work with other scientific and clinical staff in advancing our programs through the clinic. Leadership skills in managing internal and external projects are required. Compensation will be commensurate with experience and skillset.

Key responsibilities: 

1. Manage and provide direct oversight of CROs, central labs, clinical supply management and other vendors to ensure successful clinical trial implementation and execution. 
2. Closely track study site start up, timelines, enrollment, protocol deviations, regulatory documentation, and trial-related materials such as IP and laboratory sample management. 
3. Work closely with medical directors to provide input into clinical study documents such as clinical study protocols, ICFs, and site-facing materials. 
4. Work closely with PV, Data Management, and other vendors to ensure appropriate review and documentation of clinical trial data. 
5. Review and manage clinical trial site budgets and provide forecasts to the clinical development and finance team members.

Qualifications:

1. Bachelor's degree or higher with at least 8 years of biotech, pharmaceutical industry, and/or CRO clinical operations experience.
2. A solid understanding of the clinical trial processes, such as study start up, patient recruitment and safety, non-compliance, management and monitoring of CRO and investigative sites, IP accountability, database locks etc.
3. Oncology clinical development and operational experience is highly preferred.
4. Solid understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations
5. Proven ability to interact and work with external partners (CROs and consultants) with regards to clinical operation functions.
6. A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required.
7. Excellent oral and written communication skills and strong organizational skills are required. Highly experienced in utilizing CTMS, EDC, TMF and related software.