Senior Manager of Clinical Operations

Position: Senior Manager of Clinical Operations

Function: Clinical Development and Operations

Company: Phanes Therapeutics, Inc.

Location: San Diego, CA

Phanes Therapeutics is a clinical stage biotech company focused on innovative discovery research and clinical development in oncology. The company received three IND clearances from the FDA recently: PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for small cell lung cancer (SCLC). In addition, both PT886 and PT217 have received orphan drug and Fast Track designations from the FDA. 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 is 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.

Job Summary:

This position is in the clinical development and operations function located at our R&D site in San Diego, CA and will report to the head of Clinical Operations. 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 sites, clinical vendors, and clinical research organizations. The candidate should have clinical operations management and mentoring experience, including thorough experience in reviewing monitoring reports, tracking clinical operations activities, and ensuring TMF compliance and audit ready state. 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 team members.

This position is onsite full-time. 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.

Key Responsibilities:

  • Supervise and mentor a team of direct and indirect reports to ensure performance/progress on assigned projects as appropriate, including oversight of CRAs and CTAs.
  • Track and Review CRA monitoring visit reports.
  • Responsible for operational aspects for all Phanes clinical trial(s), EDC status, eTMF management, tracking regulatory documentation, and trial-related materials such as IP and laboratory sample management.
  • Responsible for ensuring TMF is audit ready, including managing, tracking, and completing TMF document QCs and approvals.
  • Manage, track, and report EDC status; follow up with CRAs and sites and escalate issues and discrepancies.
  • Manage, track, and report Protocol Deviations; follow up with CRAs and sites and escalate issues and discrepancies.
  • Manage, track and mentor CTAs with new site outreach and start up activities.
  • Participant in internal study team meetings and other internal clinical operations meetings and/or working group meetings.
  • Tracks and ensures clinical and site training documentation is completed and filed appropriately.
  • Track and escalate performance concerns with clinical sites.
  • Ensure compliance and adherence to Phanes SOPs, processes and plans, as applicable.
  • Other duties as assigned.

Qualifications:

  1. Bachelor's degree or higher with at least 6 years of biotech, pharmaceutical industry, and/or CRO clinical operations experience.
  2. Minimum 2 years of direct responsibility in monitoring visit report review.
  3. Minimum 2 years of Clinical Operations employee supervision experience.
  4. Preferred 2 years with responsibility for managing key clinical study deliverables.
  5. Prior experience as a CRA/site monitor highly preferred.
  6. Direct experience with TMF oversight and highly knowledgably on the DIA filing structure. Experience with completing TMF audits highly preferred.
  7. 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.
  8. Oncology clinical development and operational experience is highly preferred.
  9. Solid understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations
  10. Proven ability to select, manage, interact and work with external partners (CROs, consultants, and sites) with regards to clinical operation functions.
  11. A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required.
  12. Excellent interpersonal, verbal and written communication skills, while being able to work and think independently, to support a collaborative environment.
  13. Attention to detail required.
  14. Strong organizational skills with the ability to multi-task and prioritize.
  15. Highly experienced in utilizing CTMS, EDC, TMF and related software.
  16. Strong analytical and problem-solving skills; and be able to proactively identify and communicate risks and/or other issues and develop appropriate mitigation, action plans, or solutions in collaboration with key stakeholders.
  17. Ability to deal with the time demands of a fast-paced small company environment and able to adjust workload based upon changing priorities.

 Our Benefits Include:

  • Competitive compensation package including bonus opportunities and stock options opportunities
  • Exceptional career growth opportunities
  • Excellent medical, dental and vision plans
  • Generous vacation and sick leave plans
  • 16 paid company holidays per year plus flexible floating holidays
  • An opportunity to do truly meaningful work to make a lasting impact
  • On-site gym, ample parking including complimentary EV charging stations, company-sponsored events, etc.
  • Flexible spending accounts (FSAs) for eligible out-of-pocket health care and dependent day care expenses
  • Health savings accounts (HSAs) a trust or custodial account to pay or reimburse certain medical expenses
  • Life and AD&D insurance, short- and long-term disability plans
  • Employee assistance program (EAP) provides employee counseling programs and various online resources
  • Additional voluntary benefits including pet insurance, auto and home insurance, commuter benefits, legal plans, and more

The annual base salary we reasonably expect to pay is $150,000 - $190,000. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.