Clinical Trial Manager / Senior Clinical Trial Manager
Annexon Biosciences is a clinical-stage biopharmaceutical company pioneering the development of a new class of medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders. The company’s pipeline is based on its platform technologies addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway. Annexon is deploying a disciplined, unbiased biomarker-driven strategy designed to improve the probability of technical success of its portfolio and striving to deliver precision medicine to patients with classical complement driven diseases in the body, brain and eye.
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
- Residence in the SF Bay Area is preferred
Annexon Bio is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Employment is conditioned upon full vaccination against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.
Recruitment & Staffing Agencies: Annexon Bio does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Annexon Bio or its employees is strictly prohibited unless contacted directly by the HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Annexon Bio, and Annexon Bio will not owe any referral or other fees with respect thereto.