Clinical Trial Manager

About Us:

Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a team of experienced leaders with a history of developing marketed oncology small molecule drugs. Alterome recently secured $132 million in Series B funding.

Job Summary:

Alterome is seeking an experienced Clinical Trial Manager to provide trial operational oversight of CROs and vendors (including both U.S. and Ex-U.S. regions) as well as support the Alterome cross functional Clinical Team in a variety of areas. This role will ensure adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans. The successful candidate must have experience managing Phase I-III trials and a strong understanding of clinical operations, GCP, and FDA regulatory environment. This position will directly report to the Senior Director of Clinical Operations with matrix reporting to Project Management, Regulatory, and Medical.

How You'll Contribute to the Team:

• Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines, and organizational objectives of individual protocols/programs. Ensures all Vendor contracts/legal documents current and on file at Alterome.

• Metrics management as identified by Clinical Lead.

• Generate minutes for Development Team Meetings, Study Management Team Meetings as well as any Regulatory/Quality Team Meetings.

• Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.

• Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.

• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.

• Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.

• Performs periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.

• Works with vendors to revise scope of service agreements, budgets, plans, and detailed timelines, and ensure that performance expectations are met. Meets with vendors to ensure proper vendor oversight.

• Supports financial management of the study which may include review and approval of site and vendor invoices. May generate Purchase Orders to support cross functional team invoices.

• Supports Risk Management initiatives. Proactively alert cross functional team to any risks identified and note suggested risk mitigation to identified risks.

• Performs regular Protocol Deviation Review with the CRO.

• Manages cohort enrollment with the CRO.

• Oversees drug product distribution and re-supply to sites and depots.

• Supports the filing of legal team documents in SharePoint working Cross Functionally with Project Management, Clinical, Regulatory and Medical team members.

• Maintain clinical trial registry entry/updates, as required.

• Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors.

• Write/amend Informed Consent Form (ICF) templates as well as site level document review and approval.

• Review Site Regulatory Document Packages from the CRO noting inefficiencies and working towards approving packages from the CRO.

• May directly interact with clinical sites participating in Alterome clinical studies to ensure high-quality and efficient execution of ongoing and planned clinical trial operations.

• Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc.

• Performs administrative functions and additional duties as assigned.

• Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.

• Various activities in support of Clinical, Project Management, Regulatory and Medical team members.

Required Qualifications:

• San Diego based candidate with the ability to work in a team environment in a hybrid capacity (three days per week in-office is required).

• BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered.

• 5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through Phase 3 studies, both domestic and international.

• Minimum of 3 years study oversight as an in-house CTM (e.g., CRO/vendor oversight).

• Demonstrated experience and knowledge of running oncology Phase 1, FIH studies with dose escalation cohorts.

• Prior experience writing and amending study documents including ICFs.

• Demonstrated experience with trip report review and CRO oversight management.

• Experience in running a trial from start to finish; initiating the trial that includes site feasibility/start up tasks, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.

• Proven experience running a trial from start to finish; initiating the trial that includes site feasibility/start up tasks, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.

• Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

• Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP & country clinical research law & guidelines.

• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Demonstrated ability to mentor/lead.

• Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites, and therapeutic areas.

• Highly proficient in Microsoft Office (Outlook, Word, Excel, SharePoint, and PowerPoint), experience using various clinical IT applications and the ability to adapt to new IT applications.

• Ability to understand and analyze data/metrics and act appropriately.

• Possesses effective time management, organizational and interpersonal skills, conflict management, and problem-solving skills.

• High sense of accountability and urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.

• Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships.

• Ability to foster effective relationships with sites, vendors, and colleagues.

• Strong communication skills.

• Works with high quality and has a compliance mindset.

• Impactful written and verbal scientific communication.

Who are Alterome Employees?

Although we share varied backgrounds and come with expertise in different areas, we aim to inspire hope for those affected by cancer. Our vision unites us to develop unique therapies that transform the lives of cancer patients, one alteration at a time. Thus, we seek the best people to join this special movement and invest the resources they need to grow, develop, and accomplish our collective goals. We have a passion for what we do and truly enjoy working with each other. In fact, many of us have worked together in multiple companies and there is a genuine camaraderie amongst the group. We would love to bring new faces to the group, and that's where you come in!

Alterome Benefits:

We provide our employees with medical, dental, and vision coverage, life insurance, a 401k w/company matching, competitive compensation (including equity), paid holidays, flexible time off, home office set up, full-service gym on-site (with showers and towel service!), professional development opportunities, phenomenal company culture, and more! Our office is centrally located in San Diego, CA at the intersection of the 15 and 56 Freeways. This is a hybrid role with three days per week in the office required.

Salary Range: $130,000 - $160,000/year based on skills and experience.

EEOC Statement:

Alterome Therapeutics, Inc. is an equal opportunity employer committed to building a diverse and inclusive organization. We measure each applicant, candidate, and employee based on their qualifications for the role, regardless of age, sex, religion, sexual orientation, gender identity, national origin, Veteran status, disability, and/or any other protected class characteristics. Furthermore, Alterome is committed to achieving all business objectives in compliance with all federal, state, and local laws.