Make a career path with us
“The strength of the team is each individual member. The strength of each member is the team.” – Phil Jackson
In addition to a stimulating and rewarding workplace, Annexon offers a competitive base salary and equity participation, as well as a comprehensive health benefit package, which includes medical, dental, vision, 401(k) and flexible spending plans. We are located in South San Francisco, CA with shuttle service from BART, CalTrain and the Ferry.
We are looking for talented individuals to join our experienced, collaborative and driven team. Those who are passionate about making a difference in the lives of patients and their families and who bring that drive and dedication to the workplace are encouraged to apply to our open positions below.
Clinical Trials Manager
The CTM 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 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
- 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
- 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)
- Requires residence in the SF Bay Area
- Willing and able to provide recent job references from a variety of role-relationships (people who reported to you, peers and your supervisor) as well as a reference from a CRO PM that you managed
Director / Sr Director, Program Management
The Director / Sr. Director of Program Management is a proactive and effective problem solver who is intellectually curious and works exceedingly well with others. This role is responsible for coordinating and driving cross-functional activities required to advance a program from pre-clinical development through BLA submission. The winning skill set includes working effectively and efficiently with cross functional groups such as non-clinical, clinical, technical development, regulatory, manufacturing and commercial planning. The Director / Sr. Director of Program Management serves to help establish and execute program strategy and activities, integrating cross-functional input, synthesizing team recommendations, and directing program advancement on time and on budget. Lastly, the Director / Sr. Director of Program Management is expected to maintain consistent, multi-level communication with Development Team Members, Senior Management, and the Executive Team, including the CEO. This role will report into Global Head, Program Teams, who reports into the CEO.
- Partner with cross-functional leaders to develop comprehensive product development and lifecycle management plans (e.g., Non-Clinical, Clinical, CMC, Regulatory) that optimize value, time, resources, risk, and alignment with business objectives
- In collaboration with cross-functional team:
- Implement product development and lifecycle management plans
- Identify and manage critical path activities and resources
- Identify and manage interdependencies and hand-offs
- Identify and proactively mitigate roadblocks
- Identify and document risks, likelihoods, severities, and key mitigations
- Lead contingency planning
- Capture and communicate progress; escalate potential delays with proposed solutions
- Direct programs through corporate governance to ensure that:
- Projects have adequate resources and technical expertise to meet strategic objectives
- Issues are raised, discussed, and resolved in a timely manner
- Project teams receive management decisions in a timely manner
- Programs adhere to agreed-upon scope, timelines, resources, and budget
- Responsible for project team documentation, including agendas, minutes, timelines, development plans, discussion aids, risk logs, and decision logs
- Responsible for facilitating Core Development Team (“Core Team”) and regulatory and CMC Sub-Teams Meetings, respectively
- Present project updates, strategic issues, options, and recommendations to various R&D leadership teams, as well as the Executive Team, including the CEO
- Implement product development and lifecycle management plans
- Proven ability to manage complex, cross-functional development projects with multiple scenarios
- Expertise using Project Management software to manage timelines, resources, risks, and costs
- Ability to rapidly integrate new information into existing plans
- Ability to influence across all levels of the organization
- In-depth knowledge of global, early-stage, biologic drug development
- Provide Senior Management and the Executive Team with timely, candid and accurate information, options, and recommendations
- Prior experience working in a fast-paced, entrepreneurial, development-stage company
- Ability to achieve business results with colleagues of diverse levels, functional expertise, skills, and priorities: effective as both a team player and a team leader
- Maintain a clear focus on business objectives
- Take a hands-on, “roll up your sleeves” approach
- Drive, facilitate, track, anticipate, influence, and implement
- Challenge the status quo where relevant
- Resolve conflicts within the team and otherwise be a good “glue” type of person culturally
- Think strategically and craft solutions
- Undergraduate degree in a scientific, medical or business discipline. A postgraduate qualification (e.g., Ph.D., MBA, MS) will be a distinct advantage
- PMP Certificate a plus
- Knowledge of project management methodologies, concepts and techniques is required.
- A minimum of 10 years of biopharmaceutical industry experience, with half in a Project Management function
Scientist / Sr Scientist
We are seeking an accomplished scientist in Immunology and/or Neuroscience with a deep understanding of disease mechanism and ability to translate basic research findings into novel drug targets, in-vivo proof of concept and clinical relevance using the best available technologies. The right person for this role will have experience in a field of neuroscience or immunology demonstrating mechanistic understanding of a biological or disease process and should have a track record for being able to scientifically rationalize, develop and execute assays towards the goal of mechanistic understanding.
- The successful candidate will have experience streamlining their work towards target validation, screening assays to identify novel leads and select candidates for in-vivo testing for proof of concept studies.
- Initiate novel drug discovery projects and support existing targets from basic biology to clinical proof of concept studies.
- Collaborate efforts with academic labs and with external CROs to drive new technologies and execute on project deliverables for Annexon programs.
- Must be independent with the ability to work collaboratively in a team, with excellent laboratory skills in biochemical, cellular, histological and/or functional assays.
- 4-10 years’ academic or industry experience post PhD in in vitro or in vivo biochemical, cellular, histological or functional biology.
- Proven experience working with a variety of experimental technologies/platforms and models, developing novel experimental methods and data analysis routines.
- Excellent problem solving skills and ability to take on new challenges, with excellent personal and scientific communication skills.
- Experience in fluid-biomarkers, basic protein characterization methods, Flow cytometry, proteomics, and/or genomic techniques would be a plus.
Please submit resumes to firstname.lastname@example.org.
Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.