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, 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.
· 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
Head of Biomarkers
Head of Biomarkers
The Head of Biomarkers is responsible for developing and implementing strategies for clinical biomarkers across the entire Annexon discovery and development portfolio. This strategy is critical to Annexon’s precision medicine approach in the key therapeutic areas of Autoimmune diseases, Neuroscience and Ophthalmology. This individual will serve as an important Annexon leader and integrator between research and development. He/she will also oversee operational aspects such as the collection and analysis of all clinical biosamples and interfacing with external vendors to obtain timely and high-quality data.
• Develop biomarker strategies to enable precision medicine approaches and optimal selection of patient indication and patient subsets in clinical trials.
• Develop biomarker strategy to align the clinical development plan from Phase I to III.
• Supervise biomarker assay development, validation and implementation.
• Lead operations for collection, management and analysis of clinical trial patient biomarker samples.
• Develop biomarker analysis plan and oversee biomarker data analysis; leads the analysis of biomarkers for clinical studies by working with key internal stakeholders and external CROs as needed.
• Provide consultation to pre-clinical programs to drive formulation of biomarker strategy at an early stage of development.
• Responsible for the integration of scientific learnings and clinical biomarker data to define targeted patient populations and enable selection of potential diagnostic platforms.
• Provides expert guidance to multi-disciplinary teams and senior management; act as the Biomarker representative on Project teams.
• Author biomarker strategy documents, biomarker specific portion of clinical protocols, and regulatory documents.
• Use biomarkers to identify opportunities to study compounds in new indications/combinations. • Identify, establish and oversee external collaborations with key opinion leaders, academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers.
• PhD and/or post-doc training in the area of immunology, or other related medical science field with a minimum of 15 years of relevant biotechnology or pharmaceutical industry experience.
• Knowledge of biomarker discovery and development, assay development/validation, clinical discovery of biomarkers, and MoA/translational research.
• Candidate must be detail-oriented with excellent record keeping and organizational skills.
• Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced and dynamic, team-oriented environment.
• Excellent collaboration, communication, and interpersonal skills are required to engage and be productive within a high achieving team environment.
• Ability to integrate complex scientific ideas, generate testable hypotheses, and execute broad understanding of drug discovery and development in both early and late stage development.
• Familiarity with regulatory approval process.
• Basic understanding of technical aspects of companion diagnostics development
• Proven scientific/leadership expertise (working in teams, managing people/projects commensurate with a senior level).
• Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments.
Annexon Biosciences is a private, clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.Apply Online
VP, Project Team Leader
VP, Project Team Leader
Annexon Biosciences is a clinical stage biotechnology company focused on developing novel inhibitors that are designed to block C1q and the entire classical complement pathway. We are pioneers in targeting C1q, the initiating molecule of the classical complement pathway. By stopping the start of this pathway, our C1q inhibitors are designed to treat multiple complement-mediated autoimmune, neurological and ophthalmic diseases of the body, brain and eye. Annexon is headquartered in South San Francisco CA.
As the leader of our Autoimmune franchise, the VP, Project Team Leader will provide strategic scientific, business and operational leadership and direction of the R&D development and advancement of Annexon’s portfolio. In addition to developing and driving a comprehensive lifecycle portfolio strategy, the VP, Project Team Leader shall be responsible for leading a cross functional leadership team of both internal and external resources in all aspects of development pre-IND stage through late stage development, ensuring consistent high quality output from the team and achievement of program goals and objectives as well as drive effective execution of such strategies by leading the cross functional team’s engagement, integration, coordination and communication across functional lines. Duties for this role also include managing R&D partnerships, helping to build necessary infrastructure for the R&D organization and working with the executive leadership to create an environment that supports rapid and high quality decision making (both for the portfolio and the organization) and to identify, evaluate and find solutions for key issues facing the programs on an ongoing basis.
· Partnering with internal and external stakeholders to drive the development of a comprehensive strategic plan through registration and pre-commercialization preparation, including goals, budget and risk assessment. Includes developing program vision, strategy, scope/focus, milestones, risk assessment and management strategies, as well as project investment requirements.
· Leading cross-functional Project Team focused on the development of Annexon’s clinical candidates, from pre-IND through late stage clinical development and NDA submission for multiple indications. Project Team shall include representation from Research, Development, CMC, Regulatory, Quality, Commercial and Finance.
· Providing effective leadership and direction to the cross functional Project Team, including scientific and operational oversight of activities, budgeting and planning.
· Utilizing his/her understanding of disease biology, global drug development and portfolio management within the field of Autoimmune disorders to effectively lead the Project Team.
· Partnering with executive team to develop operating framework within R&D, including with regard to the Project Team to clarify and facilitate decision-making and escalation around strategic direction, resource allocation, etc.
· Partnering with functional areas to identify and ensure adequate resources for timely completion of goals and objectives. Ensuring team members understand program objectives, specifications, deliverables, timelines, and tasks.
· Driving the development and implementation of lifecycle portfolio strategy and follow-on drug candidates for multiple diseases.
· Managing and communicating program progress on a continual basis, identifying both cross-program and cross-functional issues, resource issues, timeline issues, and budget issues.
· Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles
· Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results
· Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
· Ensures budgets and schedules meet corporate requirements
· Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major internal and external customers.
· Works on abstract problems across functional areas of the business.
· Identifies and evaluates fundamental issues for major function areas through assessment of intangible variables. In-depth knowledge of functional areas, business strategies and company goals.
· Interacts internally and externally with executive level management requiring negotiation of matters to influence policymaking bodies both internally and externally.
· Anticipates potential roadblocks and issues of conflict and maintains open lines of communication in problem solving and resolving issues and conflict.
· Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.
· Strategic Agility: Ability to develop and execute complex strategies.
· Collaboration/Relationship Management: Ability to effectively collaborate in and across multiple
· functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment.
· Influencing: demonstrated skills in persuading senior leadership on strategy, initiative(s) implementation, and decision-making. Influences and motivates others to achieve objectives.
· Decision Making: Strong decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact.
· Communication: Excellent communication skills (both orally and written) is critical to the success of the role.
· Business Excellence: good at developing the processes necessary to get things done,
knows how to organize people and activities and knows what to measure and how to measure. Demonstrated ability to interpret data into actionable items.
· Negotiation: Proven negotiation skills that effectively drive discussions and decisions to desired end-results that have broad organizational impact.
· The successful candidate should have an advanced degree in life sciences or medicine (MD or PhD) and/or an MBA. He/she will have at least 10 years of industry experience in drug development, including experience in early phase non-clinical and clinical drug development, regulatory knowledge and pre-commercial market preparation.
· Prefer scientific or industry experience within the autoimmune field.
· Will have a proven track record of being a results-oriented leader and will have 5+ yrs. leading, managing, and developing program related teams.Apply Online
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.