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.
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
Director / Sr. Director, Global Regulatory Affairs
Annexon Biosciences seeks a Senior Director/Director, Global Regulatory Affairs to provide a critical leadership role in the planning and execution of the Company’s regulatory strategies and compliance requirements. The position entails working in a highly collaborative environment with team members in Clinical Development, Clinical Operations, CMC, Biostatistics, Nonclinical, Clinical Pharmacology, Program Management, and Research.
• Plan content and timelines of regulatory submissions to ensure alignment with agreed strategies
• Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
• Lead efforts for coordinating content and publishing documents for INDs, BLAs, and their associated maintenance
• Work with department management on plans for IND/BLA submissions and lead their preparation
• Take the lead role in preparation for project documents for Regulatory Agency meetings
• Lead multidisciplinary efforts to produce regulatory documents including Investigator Brochures, Annual Reports and DSURs, Orphan Drug Applications, and Background Documents for Regulatory Authority meetings
• Work with ex-US regulatory organizations to prepare applications, respond to queries, and maintain clinical activities outside of the United States
• Maintain knowledge of the current regulatory environment, and interpret and communicate relevant issues
• Assure compliance with regulatory standards and guidance documents
• Prepare, submit, track, index, and archive electronic submissions
• Provide Regulatory guidance to Development and Research teams
• Liaise with external CRO Medical Writing and Regulatory Operations functions for coordinating and publishing submission documents
• Other tasks and responsibilities as directed by the SVP, Global Regulatory Affairs and Quality Assurance
• B.S./M.S. degree in a relevant discipline
• Minimum of 8 years of pharmaceutical Regulatory Affairs experience
• Thorough knowledge of the drug development process, drug laws, and global regulations and requirements is required
• Experience supporting development stage programs (Phase 1-3); Experience in neurodegenerative disease research highly desirable
• Strong analytical skills, problem solving ability, and presentation skills are required
• Familiarity with eCTD technical requirements
• Highly organized with proficiency accessing documentation utilizing multiple electronic systems
• Excellent communication and interpersonal skills are essentialEmail cover letter and resume to email@example.com
Director / Sr. Director, Quality Assurance
Annexon Biosciences seeks a Quality Assurance (QA) Senior Director/Director to lead the company’s clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols.
The incumbent is also responsible for developing specific internal procedures, training of staff and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Annexon’s functional areas. The candidate will perform audits of vendors, study sites, and internal processes.
The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP focused team setting and manage quality related activities at clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Annexon’s clinical stakeholders and act as a catalyst for continuous process improvement.
• Oversee the development and maintenance of GCP related quality system SOPs in compliance with all applicable regulatory requirements and to align with existing company policies
• Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements
• Manage contractors
• Manage/oversee all aspects of cQA at clinical vendors
• Create/manage/maintain quality plans for the cQA function
• Manage staff performing quality reviews of clinical study documents, which include investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms
• Manage staff performing internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards and guidelines
• Provide expert CQA advice and strategic guidance to stakeholders (e.g., Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of applicable GCP regulations
• Support the administration of the company’s training program by overseeing the conduct of GCP training to internal departments and externally, as applicable
• Manage/conduct targeted training of investigators/site staff
• Report GCP related deficiencies to senior management as well as plans for corrective and/or preventive actions (CAPA)
• Assist clinical study teams in the development of CAPAs
• Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management
• Coordinate responses to regulatory agency inspections
• Review regulatory submissions for clarity and compliance with current regulations
• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
• Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance
• Position requires a highly diplomatic, tactful and detail-oriented individual with excellent critical reasoning skills
• Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
• Ability to deal with ambiguity, creative and pragmatic approach to problem solving
• Auditor certifications a plus
• 10+ years of progressive global quality/regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems
• Thorough understanding of GCP ICH Guidance requirements and related GCP regulations. Working knowledge of GMP and GLP regulations a plus
• B.S./M.S. in relevant science fieldEmail cover letter and resume to firstname.lastname@example.org
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 email@example.com.
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.