Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.
The Clinical Trial Manager (CTM) / Senior Clinical Trial Manager is responsible for the operational management, oversight and execution of one or more clinical trials including CROs, vendors, and consultants as needed for the conduct of clinical studies. This individual will report to the Sr Director, Global Clinical Operations.
- Provides full management of 1 or more studies within the Annexon portfolio of clinical trials
- Provides study leadership and effectively collaborates with other departments and functional groups to meet study timelines and corporate goals
- Independently creates and/or oversees the design of study related documents including but not limited to: clinical protocols, case report forms, study manuals and plans, informed consent forms, safety committee charters
- Manages study-specific CROs, vendors and contractors
- Reviews CRO and vendor scope of work / work orders
- Works closely with CROs to set up study systems, such as Safety management, data management, clinical monitoring, TMF, etc.
- Responsible for review and approval of IP release packages
- Management of the labeling and distribution requirements of the IP
- Works together with the Sr Director to develop and track study budgets and financial forecasting
- Prepares study updates and tracking information for departmental / company meetings
- Establishes and leads study management team meetings internally at Annexon and via teleconferences with study vendors
- Prepares and presents study-specific slide presentations during Investigator Meetings. Leads training sessions for the training of CROs and field CRAs
- Attends scientific meetings as a representative of Annexon clinical operations team.
- Proactively identifies and communicates study-related issues and facilitates discussion of potential solutions that can be implemented by the team
- Exercises professional judgment in selecting methods and techniques for obtaining optimal results
- May participate in clinical research SOP development or updates as appropriate
- Uses well-developed problem-solving skills to address needs of program and provides leadership and guidance to others
- Attends site initiation visits, as applicable, as a representative of the study sponsor
- BA / BS, RN or higher degree
- 8+ years clinical operations experience, with 4+ years of that in the CTM role or higher, in the pharmaceutical / biotech industry
- Experience with managing CRAs and CTAs
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Management of international clinical studies
- Experience managing CROs, lab vendors and other support vendors
- Knowledge of data management process, including database build activities
- Proficient with MS Word, Excel and PowerPoint.
- Strong interpersonal, communication (written and verbal), and organizational skills
- Ability to work independently as well as part of a multi-functional study team, with a willingness to take on tasks outside of the typical job responsibilities
- Available for travel domestically and internationally (approx. 5-20%, depending on study phase)
- Experience with early phase trials, ophthalmology, immunology, and neurology is beneficial
- Experience working within a small biotech company