- 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 CRA's
- 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 other lower level personnel
- Attends site initiation visits, as applicable, as a representative of the study sponsor
Requirements - 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 CTMs, CRAs and Clinical Assistants
- Experience with early phase trials, ophthalmology, immunology, and neurology is beneficial
- Experience working within a small biotech company preferred
- Working knowledge of GCP/ICH guidelines and the clinical development process
What Annexon offers - Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. We continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented candidates have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate. To learn more about Annexon's diversity commitment, culture and values, please visit
- A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits
CompensationThe anticipated starting salary range for the Sr. Manager/AD, Clinical Operations position is $171,000 - $190,000 per year. The starting salary range for Clinical Trial Manager position is $139,613 - $155,125. The starting salary for this position will be determined based on the candidate's education, experience, transferable skills, licenses/certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation. The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.
Company Summary
Annexon Biosciences is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.
EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.
Staffing Agencies
Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon's website or Annexon Employees. Inquiries must be sent to with the Subject Heading: Staffing Agency Request.
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Senior / Clinical Trial Manager - Ophthalmology - South San Francisco, United States - Annexon, Inc.
Description
Work Location
Corporate Headquarters (South San Francisco, CA) – Hybrid
Position Summary
The 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.
Responsibilities
