AgenTus Therapeutics is a dynamic new start-up subsidiary developing T cell receptors (TCRs) and chimeric antigen receptors (CARs) designed to supercharge human immune effector cells to seek and destroy cancer. We aim to deliver cures to cancer patients around the world by leveraging our proprietary platforms for TCR discovery, targeting novel phosphopeptide neo-epitopes and developing unique allogeneic cell therapies. Together with our parent company, Agenus, we have a deep and diverse repertoire of immunotherapy treatments that can be used in combinations that will synergize to help the body’s immune system fight cancer.
The Clinical Trial Manager (CTM/Sr. CTM) has a hands-on responsibility for the leadership and conduct of clinical trials either through fully in-sourced; fully outsourced or hybrid operational model. The development programs consist of management and execution of Phase I-IV oncology and immuno-oncology clinical trials including the direction, planning, execution, and interpretation of clinical trials under ICH/Good Clinical Practices. Assist in the development and implementation of strategy, policies, and procedures. Manage aspects of external vendor contracts including CRO.
Oversee all clinical teams and programs (all phases) in the field of Immuno-oncology and other therapeutic areas as appropriate. Direct the CRO and full external and internal cross-functional team in the design, management, planning, and execution of clinical trials, including creating and managing timelines, budgets, and study management plans. Will also ensure clinical operational and development deliverables and timelines are met across the program(s). Ensures CRO oversight is conducted according to ICH/GCP. May have direct reports.
The CTM/Sr.CTM is a leader of the Trial Team and will closely partner internal stakeholders, CROs, vendors and the entire Clinical Development functions to deliver trials according to plan and in the highest quality standards.
Provides Clinical Operations expertise and strategic leadership in the evaluation, selection and management of Global Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution in several compounds, indications and therapeutic areas.
Provides operational management, therapeutic knowledge and oversight for the successful management of international clinical trials (First in Human/Phase I - IV) across multiple indications through internal clinical study teams and through the use of CROs and internal resources.
Conducts project risk analysis and develops risk mitigation strategies for a variety of complex problems, in order to maintain study deliverables. Plays a role in ensuring that the Trial Team effectively interfaces with key functional groups.
Contributes to training of junior trial team staff
Contributes to the development and presentation of clinical trial operational strategy and updates to senior/executive leadership.
Collaborates cross functionally (Medical Affairs, Regulatory Affairs, Commercial, Pharmacovigilance, etc.), in the support of products through their lifecycle
Oversees, manages and ensures clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
Maintains procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
Contribute to global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies)
Develop, review and approve Quality Documents
Manage clinical trial budgets, providing ongoing financial reporting and projections to finance group
Facilitate the development of clinical trial agreements and other relevant documents, in conjunction with legal group.
Plans and forecasts Investigational Product (IP) needs
Contributes and/or authors the creation and finalization of key trial documentation: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.
Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships
Develop and ensure execution of activities outlined in various study plans (data management, risk management, safety management, and study communication plans)
Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
Proactively manage the internal teams and CRO in all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
Contributes to building a culture of distinguishing AGENUS as the “Sponsor of Choice” for patients and physicians participating in oncology clinical trials
Contributes to making AGENUS clinical trials patient and site centric through the use of innovative ideas and technologies.
Contributes to the evaluation and deployment of innovative technologies.
Travel: 25% domestic and international
Bachelor’s degree preferred in a relevant scientific or healthcare discipline or equivalent experience
Minimum of 2 – 6 + years of Clinical Operations experience in Biopharmaceutical development with experience moving product candidates from Phase I through pivotal studies or equivalent, title is considered based on all qualifications and number of years of experience.
Required & Desired Knowledge
Management of FIH - Phase 3 Programs from start-up to registration (NDA) as well as understanding of drug development from pre-IND through NDA
Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
Strong knowledge of GCP’s governing clinical trials and working knowledge of FDA, EMA and ICH registrations and guidelines
ICF and CSR writing experience required; FDA and other Regulatory Agencies inspection experience highly desired
Experience managing clinical trials, CROs, budgets, and timelines required
Working knowledge of MS Project and developing Gantt charts or equivalent
Excellent team management abilities with a comfort level working with senior management
Start -up experience in biopharma a plus
Solid oral, written, and medical communication skills required
Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs is preferred
Management of CROs, multiple vendors, and complex protocols
Experience in planning tactical direction, interrelationships and business needs working with CRO’s on FIH - phase 3 Global Clinical Trials.
Experience with Immunology/Oncology is preferred. Proven experience in the oversight of the operational aspects of all stages of clinical trials
Ability to organize and manage multiple priorities required. A sense of urgency is a must
Ability to function at a high level in a team setting whether leading an external group at a CRO or acting as an individual contributor
Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
Proactive and positive management approach
Flexibility to adapt to changing program needs
Establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance trial team goals and objectives
Sound understanding of clinical research process, methodologies to provide solid analytical input and establishing him/herself as a reliable subject matter expert.
Ability to build strong relationships with co-workers of diverse backgrounds and expertise