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.
Associate Director/Director CMC
This position reports into the Vice President of CMC & Supply Chain Logistics. The Associate Director or Director will oversee efforts to develop and manufacture drug substance and drug product and to track clinical drug inventory.
· Act as a supporting contact to oversee production activities at CMOs and provide technical support and troubleshooting.
· Collaborate with other functions at Annexon to develop and implement specifications for drug substance and drug product specifications and if needed, collaborate with QA and other functions to manage out of specifications, deviations and investigations.
· Collaborate with Clinical Operations to ensure that drug supplies are available on-time for support of clinical studies.
· Author and/or review batch records, change controls, and other technical documents.
· Oversee the development and validation of analytical methods according to ICH guidelines to ensure effective characterization and release of clinical batches.
· Design and oversee formulation development and stability studies for drug substance and drug product for multiple compounds.
· Collaborate with QA, Regulatory Affairs and other functions towards timely generation of regulatory documents.
· Work with discovery project leaders to determine if a viable initial development pathway for initial development exists for molecules being considered as development candidates.
Qualifications and Other Required Knowledge and Skills:
· A BS/MS/PhD in Analytical Chemistry, Biochemistry, or Pharmaceutical Chemistry is required, with 10+ years of related industry experience in drug substance and/or drug product development, production and analysis.
· An in-depth knowledge and drug development experience in biologics, preferably monoclonal antibodies,is strongly desired, from early to BLA stage development.
· Familiarity with protein purification, protein analytical and characterization techniques.
· Familiarity and working knowledge of GMP/ICH regulations required, with experience working in a GMP facility preferred.
· Team oriented professional with excellent organizational, communication, leadership and problem-solving abilities.
· Working knowledge of quality by design and risk management is strongly desired. Knowledge of ICH Q8/Q9 and Q10 is preferred.
· Experience overseeing external CRO based resources for production of drug substance and drug product.
· Demonstrated ability to successfully coordinate multiple work streams and development efforts in a timely and economically responsible manner in small, start-up biotech companies.
· Experience and familiarity with successful operation in the biologics CMC regulatory environment for early to mid-stage development.Apply Online
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 essentialApply Online
Director, Program & Portfolio Management
Director, Program & Portfolio Management
The Director, Program & Portfolio Management is a proactive and effective problem solver who is intellectually curious and works exceedingly well with others. This role is responsible for managing and driving cross-functional activities required to advance a program from preclinical development through BLA submission. The winning skill set includes working effectively and efficiently with cross- functional groups including nonclinical, clinical, technical development, regulatory, manufacturing, commercial planning and finance. As a key member of the Core Team, the Director, Program & Portfolio Management will work closely with the GPL (Global Program Leader) to help establish and execute program strategy and activities, integrate cross-functional input, synthesize team recommendations, and ensure program advancement on time and on budget. Lastly, the Director, Program & Portfolio Management is expected to create and maintain consistent project documentation including project plans, timelines, trackers and communications. This role will initially report into the SVP of Project Portfolio Strategy & Operations.
· In partnership with GPL and Core Team, develops and maintains integrated product development and lifecycle plans.
· Creates and maintains project timelines that are critical tools for tracking progress against goals; closely and transparently manages the critical path of the project.
· Proactively identifies critical milestones, interdependencies, risks and resource constraints that could impact project timelines and collaborates with teams to develop appropriate solutions.
· Co-facilitates Core Team Meetings with GPL.
· Responsible for Core Team documentation including meeting agendas, minutes, action item and decision trackers.
· Ensures that all team members are fully informed and knowledgeable of project activities and status; optimizes communication within and between teams, in and outside of meetings.
· Partners with Core Team to proactively address acute issues that arise.
· Ensures that consistent project management tools and practices are used across team.
· Supports continuous improvement efforts in Project Management practices at Annexon; leads department initiatives.
· Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.
· Undergraduate degree in a scientific, medical or business discipline; postgraduate qualification (e.g., Ph.D., MBA, MS) or commensurate experience is a distinct advantage.
· A minimum of 10 years of biopharmaceutical industry experience, with half in a Project Management function supporting highly matrixed drug development teams comprised of, but not limited to, functional area representatives from Research, CMC, Regulatory, Clinical, Marketing and Finance.
· Solid understanding of activities critical to early and late stage drug development projects; commercial-stage a plus.
· Proven ability to manage complex, cross-functional development projects with Go/No Go decisions.
· Well-versed at scenario planning and capable of rapidly integrating new information into existing plans.
· Excellent meeting planning and facilitation skills.
· Highly proficient at both building and maintaining Gantt charts, tracking systems, spreadsheets and tools that support a systematic and scalable approach to managing projects.
· Highly organized, excellent writing and oral communication skills, motivated and analytically rigorous.
· Experienced at partnering with team members to determine planning assumptions that drive timelines and budgets.
· Adept at skillfully managing complex and challenging situations.
· Team-oriented, with excellent interpersonal skills (i.e. collaboration, conflict management and negotiation).Apply Online
Sr. Director, Clinical Operations
Senior Director, Global Clinical Operations
This position reports into the Vice President of Global Clinical Operations. The Sr. Director will contribute to the development and implementation of clinical studies. Responsibilities include providing leadership to staff and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements. Establish and lead meetings with CROs and other trial vendors and serve as a key escalation point for teams and vendors. The Sr. Director will contribute Clinical Operations expertise in cross-functional meetings and develop and implement department initiatives. Management and mentoring of direct reports (Director through entry level) is expected.
Accountable for the oversight and execution of multiple clinical trials including:
- Member of core team(s) providing strategic direction to study teams to meet corporate goals and timelines
- Develop, implement, and provide oversight of vendor budgets and contracts
- Tracking and reporting of study metrics
- Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion
- Develop and manage effective working relationships with Investigators and other key clinical opinion leaders
- Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct
- Remains current with therapeutic areas under study, industry practices / trends and FDA requirements. Applies this knowledge to current programs
- Partners with and maintains regular contact with key stakeholders including Regulatory, Clinical Development, Legal, Finance, and others as necessary
- Leads the team in the selection of Contract Research Organizations (CROs) for both large budget and small budget
- Attends CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals
- Contributes to definition, development, and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices
- Travel may be required up to 30% in support of clinical study activities
- BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience
- A minimum of 15 years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in neurology and ophthalmology drug development. Strong leadership skills with ability to be hands-on and lead/ manage the clinical team. Experience with direct line-management of clinical operations staff.
- Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines
- Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors
- Experience with financial budgeting or reporting
- Ability to interact with investigators, vendors, and individuals at all levels of the organization
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.