About Soleno Therapeutics Inc

Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way.

Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time. We encourage you to join us in making history. We all share the most important goal of bringing solutions to the PWS community. They are waiting.

Summary of Job (brief description)

The Clinical Trial Manager reports to Soleno’s Senior Director, Clinical Operations and is a key leader in the Clinical Operations department contributing to the execution of Soleno’s clinical trials across all phases, in accordance with company goals and budgets. This individual will work closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with the protocol(s), SOPs, ICH GCP, regulatory authorities’ regulations/guidelines, and applicable SOPs. This role requires adaptability and willingness to travel domestically and internationally as needed to support trial execution.

Responsibilities

• Manages the operational aspects of clinical trials including but not limited to timelines, budget and resources.
• Works closely with the Senior Director, Clinical Operations to ensure adequate resourcing and trial support.
• Participates in and facilitates Contract Research Organization (CRO) and vendor selection processes for outsourced activities.
• Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• Manages CRO and vendor interactions, including sponsor oversight of operational functional activities (e.g., trial management, site monitoring and management, project master files) to ensure compliance with the contracted trial specifications and applicable SOPs.
• Participates in development and review of protocol, case report form (CRF) development, trial plans, Clinical Study Report preparation, and New Drug Application / Marketing Authorization Application (NDA/MAA) submissions, as appropriate.
• Prepares, reviews and approves trial-related tools, worksheets and documents (e.g., informed consent template, Clinical Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
• Prepares trial metrics and updates for management, as assigned.
• Proactively identifies potential trial issues, mitigates risks, recommends and implements solutions to ensure compliance with the protocol, SOPs, regulatory requirements and ICH GCP guidelines.
• Reviews and approves investigator clinical trial agreements and site payments.
• Organizes, attends, and manages internal team meetings, CRA meetings, investigator meetings, CRO meetings and other trial-specific meetings.
• Drives investigator selection process by development of potential investigator listing and customization of trial specific tools (e.g., Site Profile, Site Feasibility Questionnaire and pre-trial tracker).
• Works with CRO or assigns clinical research associate (CRA) to conduct pre-trial contact, review pretrial contact reports and vetting documentation to ensure compatibility with the requirements of the proposed trial.
• Provides input to the Project Director (PD) regarding investigator and site selection, notifies investigators of participation status.
• Collaborates with the trial team and CRO as appropriate to monitor trial recruitment and strategies, monitoring visits and reports, data quality, and escalation of serious GCP noncompliance or protocol deviations.
• Participates in CRA selection, training and transition process for any site re-assignments.
• Manages monitoring performance issues by report review and observation visits and escalates any significant findings.
• Notifies the PD of any important protocol deviations reported by CRA and facilitates follow-up as specified in the Project Management Plan.
• Works directly with the CRA and with the CRO Project Manager and PD to resolve persistent or significant non-conformance issues at clinical trial sites and recommend removal when appropriate.
• Oversees investigational product (IP) accountability to ensure activities and records document a product chain of custody to track IP from time leaving the depot until time used by a participant, destroyed onsite, or returned to depot.
• Verifies quality checks and reconciliation of the [electronic] Trial Master File (TMF) documents is completed according to the trial TMF plan.
• Participates in the development, review and implementation of departmental SOPs and processes.
• Recommends and implements innovative process ideas to enhance clinical trials management and be feasible and promote improvements from a monitoring perspective.
• Participates in the selection, development, training, management and evaluation of trial personnel (contract and internal) to ensure the efficient operation of the function.
• Oversees Clinical Trial Associate activities (e.g., site activation, investigational product release, essential document filing) to ensure timely trial start-up and conduct.
• Participates in inspection readiness and audit reviews and ensures implementation of corrective and preventative actions, as applicable, within specified timelines.
• May manage clinical operations staff and contribute to yearly evaluations, provide development opportunities and address any performance issues identified.
• Performs other duties as assigned.

Qualifications

• A Bachelor of Science degree required.
• A minimum of 6 - 8 years of related clinical trial management experience.
• Must have strong Phase 1 clinical trial experience, including oversight of first-in-human or proof-of-concept studies.
• Demonstrated experience with the unique operational and regulatory considerations of early-phase trials.
• Rare Disease experience preferred.
• Experience in managing outside vendors (e.g., CROs, central laboratories, and other vendors)
• Strong knowledge with advanced concepts of clinical research and able to work effectively in a team environment.
• Strong knowledge and experience with clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required.
• Ability to provide clinical operations expertise in a specified product area or project.
• Excellent written and verbal skills required. Must display strong analytical and problem-solving skills. Attention to detail required.
• Proficient in MS Suite.
• Demonstrated leadership to drive results that are needed to achieve company objectives.
• Must possess excellent interpersonal skills.
• Must have the ability to build and maintain positive relationships with management, peers, and direct reports.
• Ability to deal with time demands, incomplete information or unexpected events.
• Ability and willingness to travel domestically and internationally as required by trial needs.

Salary Range: $145,000 - $185,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)