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

Our Values

Icon of warrior bow
Warrior Spirit
Balances
Sound Judgement
Passion
five hands together
All for One
tree
Thrive!

Benefits

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.

Open Positions

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.

Assistant Controller

General & Administrative

Assistant Controller

Job Description


Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. 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. 

Assistant Controller is a “hands on” position that will report directly to the VP, Controller, and support Annexon’s critical pipeline milestones, as well as the company’s growth toward becoming a multi-product commercial-stage biopharmaceutical company.  The position will be responsible for overseeing the financial close process, accounting operations, clinical trial and manufacturing accounting, and SOX responsibilities.  The Assistant Controller will partner with the accounting team, vendors and CRO’s (Contract Research Organizations), project teams and external auditors to meet accounting and finance objectives.  The ideal candidate will have operational experience in SOX 404(b) environment including oversight of internal controls associated with accounting activities. 


Specific Responsibilities

  • Month end close activities with oversight of all GL recorded transactions (including journal entries) and ensuring all GL accounts are properly reconciled on a timely basis maintaining GAAP compliance  
  • Maintenance and improvement of processes to support the Company’s accounting and reporting related to clinical trial and manufacturing expenses, including communicating with business partners (internal & external) for preparation of journal entries, reconciliations, audit support, SOX PBC schedules
  • Lead monthly meetings with external CRO’s, senior clinical and manufacturing management to provide project status updates and obtain validation of percentage and units completed
  • Ensure the accuracy and adequacy of various non-clinical liabilities, including accounts payable and accrued expenses, accrued compensation and related expenses, and other liabilities
  • Oversee outsourced payroll activities and ensure timely and accurate payroll processing and reconciliation
  • Oversight of equity related transactions including working with external stock plan administrator to records and reconcile equity activity 
  • Able to identify, optimize and automate accounting processes and drive efficient and streamlined close process
  • Support annual and quarterly audit preparation activities including SEC filings (10Q, 10K, 8-K, Proxy) and assist with disclosures as needed
  • Act as point person for external audit and outsourced tax group support
  • Participate and support the maintenance of Sarbanes-Oxley internal control certification requirements
  • Work with outsourced providers on ERP system design, implementation, and enhancement
  • Special projects as requested, particularly related to implementation of new processes and accounting policies 


Qualifications

  • Bachelor’s degree in Accounting or related field and CPA required with at least 8 years of experience with at least 3 years of experience in auditing (preferably in a Big 4 accounting firm)
  • Life Science industry experience preferred with specific experience in drug manufacturing and clinical trials
  • Strong knowledge of GAAP, SEC reporting and SOX 404 compliance
  • Ability to grow, manage and develop a diverse accounting team in a dynamic environment
  • Proficient using Microsoft Office Suite tools and ERP systems
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
  • Comfortable in a fast-paced, small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Ability to establish strong business relationships and interact cross-functionally at all levels.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
  • Advanced Excel skills required


Apply Online

Clinical Trial Manager/Senior Clinical Trial Manager (SSF, CA or Remote)

Development

Clinical Trial Manager/Senior Clinical Trial Manager (SSF, CA or Remote)


Annexon Biosciences is a 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.


Summary

The Clinical Trial Manager (CTM) / 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

  • 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 CRAs
  • 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 others
  • Attends site initiation visits, as applicable, as a representative of the study sponsor

 

Qualifications

  • 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 CRAs and CTAs
  • 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) 

Preferred Qualifications

  • Experience with early phase trials, ophthalmology, immunology, and neurology is beneficial
  • Experience working within a small biotech company 
  • Residence in the SF Bay Area is preferred 


Apply Online

Director/Senior Director, Bioanalytical Sciences (SSF, CA or Remote)

Development

Director/Senior Director, Bioanalytical Sciences (SSF, CA or Remote)


Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. 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.

 

Summary

Annexon Biosciences is seeking a proven bioanalytical scientist who will support projects across the Annexon portfolio.

Bioanalytical sciences leads the development, evaluation, and implementation of state-of-the-art bioanalytical methods to support pharmaceutical product development across the Annexon pipeline. These strategies are critical to Annexon’s integrated approach in the key therapeutic areas of Autoimmune diseases, Neuroscience and Ophthalmology. This individual will serve as an important Annexon leader and integrator between preclinical research and clinical development and will apply leading-edge approaches to inform decision-making across the portfolio.


Responsibilities

  • Accountable for planning, implementation and execution of bioanalytical PK, TE, PD, and immunogenicity assays to inform decision making and regulatory readiness
  • Provide scientific leadership and consultation to preclinical and clinical programs across all stages of development to drive formulation of disease- and molecule-specific strategies 
  • Independently lead and coordinate sample testing, trouble-shooting, and reporting, and/or oversee vendors responsible for this 
  • Guides the development and execution of stage-appropriate bioanalytical strategies including timelines and resource needs to meet project goals. Scope includes translational nonclinical studies and clinical studies in collaboration with relevant stakeholders such as the research and clinical pharmacology functions
  • Support integration of bioanalytical strategies and knowledge across Annexon development programs and molecules, including managing prioritization across programs
  • As a key member of program teams and sub-teams, support collaborative decision-making and achievement of program goals while integrating the bioanalytical sciences perspective
  • Support growth, process, and capability development for a growing clinical pharmacology and bioanalytical organization in a dynamic and team-orientated environment
  • Author relevant sections of technical reports, regulatory documents, and other documents for internal/external communication
  • Compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations as well as internal/external guidance


Key Qualifications

  • PhD degree or related degree (e.g. MSc / Pharm D) and/or post-doc training in the area of biochemistry, cellular or molecular biology, analytical chemistry, clinical pharmacology, immunology, or other related field with a minimum of 7-10 years of relevant biotechnology or pharmaceutical industry experience.
  • Experience across small and large molecule drug development
  • Advanced knowledge of assay development, qualification, validation, and regulatory standards for PK, TE, PD, and immunogenicity assays
  • Understanding of regulatory approval processes (US and ex-US, IND/CTA and BLA/MAA)
  • Must be a highly flexible, results- and detail-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
  • Proven scientific/leadership expertise (working in teams, managing internal and outsourced projects)
  • Residence in the SF Bay Area is preferred

Apply Online

Director/Senior Director, Clinical Development (SSF, CA or Remote)

Development

Director/Senior Director, Clinical Development (SSF, CA or Remote)


Annexon Biosciences is a 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.

 

Summary

Annexon Biosciences is seeking a proven clinical sciences leader who will lead projects across the Annexon portfolio.

Reporting into the Head of Autoimmunity Development and Clinical Pharmacology and Bioanalytical Sciences, the Director/Senior Director, Clinical Development will lead the design and execution of one or more clinical studies and will provide medical, scientific, and operational guidance to cross-functional study teams. These strategies are critical to Annexon’s integrated approach in the key therapeutic areas of Autoimmune diseases, Neuroscience and Ophthalmology. This individual will serve as an important Annexon leader and integrator across clinical development and will apply support and oversight across the portfolio. The Director – Senior Director Clinical Development will also be responsible for helping the team to integrate safety data across multiple studies for investigational agent(s).


Responsibilities

  • Accountable for design, planning, and execution of clinical development programs
  • Provide leadership, clinical and scientific expertise, and consultation to preclinical and clinical programs across all stages of development
  • Clinical support and oversight and overall responsibility for monitoring study conduct and safety while relying upon sound judgment
  • Author relevant sections of study/program level documents (e.g. clinical protocols, investigator brochures, case report forms, safety updates, submission dossiers, and regulatory interactions) and abstracts/publications for external communication
  • Independently perform data analysis, interpretation, integration, and reporting, and/or oversee vendors responsible for this and communicate findings to internal/external stakeholders
  • Interface with clinicians/investigative sites for protocol related interpretation and clarification, determination of study participant eligibility, and issues of participant safety
  • Contribute to regulatory filings (e.g. BLA, NDA); prepare relevant sections of regulatory documents and serve as clinical representative for communications with regulatory agencies
  • Provide clinical and scientific guidance to internal/external partners
  • Liaise with clinical and scientific key opinion leaders in the field related to assigned programs and therapeutic area(s)
  • Support growth, process, and capability development for a growing the clinical development organization in a dynamic and team-orientated environment
  • Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidances


Key Qualifications

  • MD, DO, or non-US equivalent of MD degree, PhD, PharmD, MS, or nursing background with a minimum of 5 years of relevant biotechnology or pharmaceutical industry experience in clinical development, medical affairs, or pharmacovigilance.
  • Clinical trial design and management experience required
  • Regulatory communication experience preferred
  • Understanding of regulatory approval processes (US and ex-US, IND/CTA and BLA/MAA)
  • Must be a highly flexible, results- and detail-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 proactively evaluate issues and solve problems
  • Proven clinical leadership expertise (working in teams, managing internal and outsourced projects)
  • Strong verbal, writing, presentation, and editing skills
  • Ability to operate independently in a matrixed organization
  • Strong knowledge of global regulatory requirements, GCP, and ICH guidelines
  • Residence in the SF Bay Area is preferred
Apply Online

Director/Senior Director, Global Pharmacovigilance (SSF, CA or Remote)

Development

Director/Senior Director, Global Pharmacovigilance (SSF, CA or Remote)


Annexon Biosciences is a public, 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. 

Summary

The Director/Senior Director, Global Pharmacovigilance will work closely with the relevant Medical Monitors and Clinical Development Lead Physician(s) to facilitate signal detection monitoring, product risk-benefit assessment, and safety assessment activities of investigational products within individual clinical programs and – as applicable – across the portfolio. This individual will set direction of pharmacovigilance activities for ensuring compliance with all applicable laws and regulations and as appropriate and local and foreign regulatory reporting requirements. 

Responsibilities 

  • Reviews all appropriate safety data from various sources throughout the product development lifecycle.
  • Facilitates medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).
  • Ensures accuracy of case narratives, coding and medical reviews  and ensures appropriate queries are raised for a comprehensive medical review by relevant company physician(s).
  • Authors/reviews relevant sections of all aggregate safety reports and ensures the overall quality of documents.
  • Authors, reviews and provides input as applicable for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator’s Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)
  • Ensures awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs; participates in investigators’ meetings to provide training on adverse events reporting as required. Responsible for facilitating responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues.
  • Oversees the activities of outsourcing vendors and individuals contracted to perform drug safety and pharmacovigilance activities.
  • Assists Medical Director(s) in the analysis, identification and reporting or possible trends and concerns regarding compounds and key related products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
  • Ensures that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
  • Assist in the creation, review and implementation of new SOPs, work instructions, guidelines, documents and other tools pertaining to safety.
  •  Ensures adequacy of the monitoring of clinical trial safety and monitors site compliance with protocol-specified measures intended to ensure the safety of subjects.
  • Participates in inspection readiness activities and preparation as needed.

Qualifications

  • Bachelor of Science degree required with a minimum of 8 years of experience in a  Pharmacovigilance capacity in a biopharma company in a global clinical trial environment. An advanced degree (M.S., Pharm.D. Ph.D., MPH, BSN+RN) and post-marketing pharmacovigilance experience a plus.  
  • A thorough understanding of the global pharmacovigilance regulatory environment with working knowledge of US and EU regulations (e.g. MedDRA, WHODRL), ICH guidelines, and a working understanding of drug safety databases (e.g. ARGUS), effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
  • Thorough understanding of the drug development process.
  • Flexibility and agility to function on various levels of the role as required in a fast-growing environment.
  • Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.
  •  Excellent interpersonal and communication skills, organizational and decision-making abilities, and ability to adapt to a dynamic and complex regulatory and business environment while working effectively with multiple global cross-functional teams.
  • Residence in the SF Bay Area is preferred.
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Research Associate/Sr. Research Associate - Assay Development

Research

Research Associate/Senior Research Associate - Assay Development


Annexon Biosciences is a 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.

 

Summary

We are seeking a research associate / senior research associate with excellent laboratory skills and experience in neurobiology/immunology to join our multi-functional research team. This position will provide an opportunity to grow and develop scientifically in complement biology and neurodegenerative disease areas via internal and collaborative efforts.  Some responsibility for general lab management is expected. 

Responsibilities

  • Hands-on assay validation for fluid-biomarkers using ELISA-based assays
  • Execution & development of in vitro biochemical and cellular assays for target validation, screening and biomarker discovery
  • This position will also provide opportunities to grow and develop scientifically through our collaborative efforts and ability to Interface with external CROs in driving projects, new technologies and target deliverables for our programs

Qualifications

  • Bachelor’s/Master’s degree in life science or related field with 3+ years of experience in research laboratory setting
  • Independent scientist who is a good problem solver, dependable, and ability to work effectively and independently in a multidisciplinary team environment
  • Experience in working with a variety of experimental techniques, developing assays, optimizing methods and data analysis 
  • Must have strong work ethic, ability to multi-task and enthusiasm for laboratory work
  • Strong oral/written communication skills 
  • Self-motivated to look for ways to improve and promote quality
  • Proficiency in basic mathematics and chemistry


Preferred qualifications 

  • Experience in histology: immunohistochemistry, including amplified and non-amplified fluorescence and chromogenic--based immunohistochemistry (free floating and slide mounted staining), in-situ hybridization (ISH, FISH), and image capture of fresh, frozen and paraffin-embedded tissues 
  • Experience with imaging (epifluorescence and confocal microscopy) and image analysis and quantification
  • Experience with cell culture (primary and cell lines) 
  • Familiarity with a variety of lab techniques like flow cytometry, SDS-PAGE, Western Blotting


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Research Associate/Sr. Research Associate - Immunohistochemistry

Research

Research Associate/Senior Research Associate - Immunohistochemistry


Annexon Biosciences is a 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.

 

Summary

Annexon is seeking an independent Research Associate / Senior Research Associate with excellent laboratory skills in biochemical and cellular assays. 


Responsibilities

  • Execute experiment in histology, fluorescence microscopy, and immunohistochemistry, including amplified and non-amplified fluorescence and chromogenic--based immunohistochemistry (free floating and slide mounted staining), in-situ hybridization (ISH, FISH), and image capture of fresh, frozen and paraffin-embedded tissues 
  • Imaging (epifluorescence and confocal microscopy) and image analysis and quantification
  • Assay validation for fluid-biomarkers using ELISA-based assays
  • Execution & development of in vitro biochemical and cellular assays for target validation, screening and biomarker discovery
  • This position will also provide opportunities to grow and develop scientifically through our collaborative efforts and ability to interface with external CRO’s in driving new technologies and target deliverables for our programs. 


Qualifications

  • Bachelor’s/Master’s degree in life science or related field with 3+ years of experience in research laboratory setting
  • Experience in biochemical and cellular endpoints
  • Independent scientist who is a good problem solver, dependable, with excellent personal and scientific communication skills
  • Proven experience in working with a variety of experimental techniques, developing assays, optimizing methods and data analysis 
  • Experience with IHC, imaging & image analysis, Assay dev. (ELISAs, WB, assay technologies)
  • Must have strong work ethic, ability to multi-task and enthusiasm for laboratory work
  • Strong oral/written communication skills 
  • Self-motivated to look for ways to improve and promote quality


Preferred Qualifications

  • Assay validation, molecular biology


Apply Online

Senior Scientist, Biomarker

Research

Senior Scientist, Biomarker


Annexon Biosciences is a 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.

 

Summary

The Biomarker Senior Scientist is responsible for discovery, assay development and assay transfer for disease and drug related biomarkers including those for patient stratification and indication expansion. 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 integrator between research and development. This position is 50% effort working in the laboratory.


Responsibilities

  • Align biomarker discovery efforts with the clinical biomarker leads and therapeutic area heads.
  • Drive biomarker identification, assay development and preclinical validation in Autoimmune disease, Neuroscience and Ophthalmology
  • Oversee both internal and external work as appropriate
  • Support preclinical pharmacology studies as needed
  • Author IND enabling regulatory documents
  • Maintain awareness and assess new Biomarker technologies


Qualifications

  • PhD and/or post-doc training in the area of neuroscience or immunology, or other related medical science field with a minimum of 8 years of relevant biotechnology or pharmaceutical industry experience. 
  • Knowledge of biomarker discovery and development, assay development/validation, and MoA/translational research. 
  • Experience assay development for PK, PD anti-drug antibodies a must
  • Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments.
  • Ability to integrate complex scientific ideas, generate testable hypotheses, and execute well controlled experiments
  • Candidate must be detail-oriented with excellent record keeping and organizational skills. 
  • Must be a highly flexible, results oriented, independent scientist who enjoys working in a fast-paced and dynamic, team-oriented, and collaborative environment. 
  • Must be comfortable with working in a highly matrixed environment where influencing without authority is routine


Preferred Qualification

  • Experience with assay development for small molecules desirable
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Sr. Director, Clinical Data Management (SSF, CA or Remote)

Development

Sr Director, Clinical Data Management (SSF, CA or Remote)


Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. 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.

 

The Senior Director, Clinical Data Management will be responsible for managing, leading, and overseeing all Clinical Data Management (CDM) planning and operational activities to meet corporate objectives and timelines within budgets. The Senior Director of CDM will be responsible for building and leading the CDM function, setting visions for the department including strategies, operations, infrastructure, technology innovation, and talent development. The Senior Director will require leadership and organization skills, and experience with early- to late-stage clinical trials. The Senior Director CDM will collaborate closely with other functional leaders to design the best solution to meet business needs. This position will report to the Vice President, Global Clinical Operations.


Summary

To provide clinical data management oversight for all Annexon clinical projects.


Responsibilities

  • Promote standardization, automation, innovation, process improvement, and technology enhancement in CDM and beyond to increase drug development efficiency
  • Establish sound CDM processes including SOPs to ensure highest data quality/integrity and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices
  • Lead or direct CDM activities including CRF/eCRF design, validation programming, discrepancy management, and database development and production
  • Ensure all CDM documentation are complete, accurate and in an inspection-ready state
  • Champion and lead the development and implementation of policies, standards, and process improvement initiatives
  • Develop and implement a training curriculum for data management activities and principles as required
  • Ensure CROs, suppliers, and internal staff meet the highest quality standards per SOPs
  • Provide oversight and guidance, as well as establishing key performance metrics to CROs to ensure highest data quality/integrity and regulatory compliance
  • Responsible for vendor and technology (e.g., EDC or IRT) evaluation, qualification, and selection
  • Use scientific and drug development knowledge to anticipate and mitigate data management-related challenges during clinical trial execution
  • Lead strategic decision-making process involving data management issues for ongoing clinical trials, including Case Report Form (CRF) design, database design, data management plans, edit checks/quality review plans, query resolution processes, data transfers, SAE/AE reconciliation, thesaurus coding processes, and database lock
  • Provide leadership and independent judgment in the Identification and implementation of methods, techniques, procedures, and evaluation criteria to support analytical output
  • Promote productive collaboration between Biometrics and other functions (e.g., Clinical Biomarker, Clinical Operations, Clinical Development, Regulatory Affairs, QA) and ensure proper alignment around data management deliverables
  • Identify and implement solutions to global data management and EDC issues and concerns
  • Develop resource plan and budget forecast. Manage budget, timelines, and resource needs for CDM with sound judgment and efficiency
  • Provide strong leadership and inspiration to CDM staff. Recruit, develop, and motivate robust talents
  • Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers
  • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.


Qualifications

  • Bachelor's or Master’s degree in a scientific subject area
  • Minimum 15 years of CDM experience in a pharmaceutical/biotech or CRO setting with at least 10 years of line management experience; global/international experience a must
  • Sophisticated knowledge of CDM processes, EDC systems, database programming, quality management and technology advancements in the field of data management
  • In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines
  • Experience participating in regulatory submissions and inspections
  • Extensive experience in designing, leading and championing cross-functional projects with internal partners and CROs
  • Strong track record of line management and supervisory experience of CDM staff and vendors.
  • Outstanding problem-solving abilities and influencing/negotiation skills
  • Excellent interpersonal, communication, and leadership skills
  • Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
  • Ability to identify, author, maintain, and train staff on key data management SOPs and work-practice guidelines
  • Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude
  • Ability to prioritize workload and meet deadlines, demonstrate effective use of time, and handle multiple priorities simultaneously
  • Capable of actively identifying project challenges and risks and proposing appropriate solutions to issues
  • Excellent written and verbal communication skills
  • Willing to travel if required
  • Proven leadership and management skills
  • Residence in the SF Bay Area preferred 


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Sr. Director/VP Project Team Leader

Development

Sr. Director/VP, Project Team Leader

Job Description 


Company Overview:

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.  


Job Description:  

As the leader of one of our therapeutic franchises, the 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 Project Team Leader will 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. The Project Team Leader will report into the SVP, Portfolio Strategy & Operations.


Key Responsibilities:

  • 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 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.


Knowledge/Skills:

  • 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.


Qualifications

  • The successful candidate should have an advanced degree in life sciences or medicine (PhD or MD) and/or commensurate experience.  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, neurology and/or ophthalmology 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; prefer prior Project Team Leader experience.


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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.