Clinical Trial Manager (Associate – Senior)

Position: Clinical Trial Manager (Associate – Senior)

Function: Clinical Development and Operations

Company: Phanes Therapeutics, Inc.

Location: San Diego, CA

Phanes Therapeutics is a clinical stage biotech company focused on drug discovery and development in oncology. Our company has received three IND clearances from the FDA this year, PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for neuroendocrine cancers. Both PT886 and PT217 have received orphan drug 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 pharmaceutical 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:

  • Oversee all operational aspects, and act as primary point of contact, of assigned clinical trial(s), including closely track study site start up, timelines, enrollment, protocol deviations, regulatory documentation, and trial-related materials such as IP and laboratory sample management.
  • Manage and track study timelines, budget, metrics, and milestones; reports status updates to senior management team.
  • Manage and provide direct oversight of CROs, central labs, clinical supply management and other vendors to ensure successful clinical trial implementation and execution.
  • Develop, review, and oversee completion of the clinical documents including, but not limited to: clinical study protocol, ICFs, lab manuals, requisition forms, monitoring plans and reports, SIV and other training slides and materials, ISF and TMF documents and templates, other study-specific plans, documents, charters, trackers, and tools.
  • Work closely with medical directors to provide input into clinical study documents such as clinical study protocols, ICFs, and site-facing materials.
  • Work closely with PV, Data Management, and other vendors to ensure appropriate review and documentation of clinical trial data.
  • Review and manage clinical trial site budgets and provide forecasts to the clinical development and finance team members.
  • Lead internal study team meetings and other internal clinical operations meetings and/or working group meetings. Participates as the study operations representative in other study-specific or internal meetings.
  • Manage and/or participate in the selection process of vendors and/or contractors supporting a study, including but not limited to: CRO, CRA, central lab, central imaging, EDC system, IRT system.
  • Provide and/or ensures training for internal study team, vendors, third party contractors and sites and ensures training documentation is completed and filed appropriately.
  • Manage, oversee, and track performance of vendors, clinical sites selected and team members, including CRAs and CTAs for a clinical study.
  • Proactively identifies potential study issues/risks and recommends/implements solutions.
  • Participates in the development, review and implementation of departmental SOPs and processes.

 

Qualifications:

  1. Bachelor's degree or higher with at least 5 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 select, manage, 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 interpersonal, verbal and written communication skills, while being able to work and think independently, to support a collaborative environment.
  8. Attention to detail required.
  9. Strong organizational skills with the ability to multi-task and prioritize.
  10. Highly experienced in utilizing CTMS, EDC, TMF and related software.
  11. 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.
  12. Ability to deal with the time demands of a fast-paced small company environment and able to adjust workload based upon changing priorities.

 

The annual base salary we reasonably expect to pay is $110,000.00 - $160,000.00. 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.