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.

Associate Director/Director, Portfolio Strategy & Operations

Development

Associate Director/Director, Portfolio Strategy & Operations

Company Summary

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.

 

Desired Candidate Profile 

The Associate Director/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 or NDA 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 Associate Director/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 Associate Director/Director, Program & Portfolio Management is expected to create and maintain consistent project documentation including project plans, timelines, trackers and communications.


Specific Responsibilities

  • 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.

Key Qualifications

  • 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 8 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, including driving to clarity.
  • Team-oriented, with excellent interpersonal skills (i.e., collaboration, conflict management and negotiation).
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

Clinical Trial Specialist

Development

Clinical Trial Specialist


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 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.

The Clinical Trial Specialist (CTS) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Global Clinical Operations team. Responsibilities will range from clinical study coordination to data entry projects and general office work.

This position will report to the Sr. Director of Global Clinical Operations.


Responsibilities include, but are not limited to:

  • Help provide accurate and up-to-date study status information to the organization.
  • Implement accurate tracking systems, forms, and other relevant documents to support clinical studies
  • Assist the clinical operations team with vendor management, including tracking all study invoices and payments
  • Assist in the preparation of spreadsheets, presentations, etc. utilizing Microsoft Office Suite.
  • Assist in the periodic review and QC of eTMFs to support inspection readiness and archiving of completed studies
  • Maintain electronic files of clinical trial documents for ongoing projects
  • Coordinate logistics for clinical operations team meetings, kick-off meetings, etc. Prepare draft minutes from the various meetings for review and finalization
  • Assist in the tracking of clinical lab samples for multiple clinical trials, including tracking shipments of samples from lab vendors and helping maintain documentation of reconciliation practices and follow up any outstanding items


Qualifications 

  • Science or nursing degree, BA, BS, RN, or higher
  • Two or more years of experience as a clinical trial assistant or clinical study coordinator
  • Knowledge of ICH GCPs is a plus
  • Proficient with MS Word, Excel, and PowerPoint
  • Strong interpersonal, communication (written and verbal)
  • Excellent organizational skills
  • Ability to work as part of a multi-functional study team


Apply Online

Director, Biomarker Operations

Development

Director, Biomarker Operations

Job Description

Company Summary

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. 


Desired Candidate Profile

We are looking for an individual to lead and champion Biomarker Operations across multiple therapeutic areas and franchises at Annexon. The successful candidate will contribute at a broad and strategic level by developing, implementing, and executing the Biomarker and Companion Diagnostics Operations strategy.

  • Accountable for the cost efficiency and timely delivery of biomarker data and quality commitments including ICH/GCP and applicable regulations.
  • Responsible for developing and executing biomarker and companion diagnostics (CDx) operations plan for clinical studies including scenario planning, assessment of feasibility, forecasting of timelines and resource requirements.
  • Provides program and indication-specific biomarker operational expertise, innovative and flexible operational solutions and options to guide decision making, bridges both science and operations through cross functional partnerships.


Specific Responsibilities

Strategy/Planning

  • Provides strategic context and biomarker operational leadership across all clinical studies and relating companion diagnostics activities when appropriate.
  • Guides scenario planning, forecasting and cost/benefit analysis of different operational plans.
  • Responsible for biomarker operations program-level decision making, risk identification and mitigation strategies. Ensure escalation of issues and risks that significantly affect biomarker program timelines, budget, or quality.
  • Provides program specific guidance, clinical biomarker operations expertise, and industry best practices to identify efficiencies.
  • Accountable for biomarker operational program goals, milestones, and progress.

Execution

  • Responsible for the operational implementation of biomarker strategies, including budget tracking and forecasts, project timelines, contract management, and biosample management.
  • Monitor status, issues, and proactively communicate progress, challenges or changes that may impact budget, timelines to biomarker leads and project teams.
  • Develop training materials and collaborates with clinical development on site trainings for biomarker sample management logistics, sample and testing questions from sites, IRBs, and ethics committees.
  • Ensure logistical feasibility for the collection, delivery, and analysis of biosamples under the highest standards of quality, ethics, and informed consent. Work with Research to identify and implement novel and innovative biosample collection and processing techniques.
  • Manages relationships with specialty testing vendors to ensure biomarker samples are processed, tested and data are reported to meet development timelines and specifications. 
  • Contribute to relevant clinical study documents and associated systems (trial blueprint/protocol, Trial Master File, Informed consent, eCRFs, CSRs, etc.); ensuring documentation standards are followed and suitable for inspection.
  • Develops organization SOPs and implements best practice documents as appropriate.

Vendor management

  • Provides direction and oversight of biomarker outsourcing activities on a program level.
  • Support the identification and selection of biomarker vendors in collaboration with the biomarker leads and ClinOps.
  • Coordinate and support technical assessment with biomarker vendors, including reviewing of relevant SOP, sample chain of custody.
  • Contributes to contract and budget negotiations, execute contracts and statement of work to meet program deliverables.
  • Organize and host meetings involving relevant internal or external stakeholders (Clinical Biomarkers, Clinical Ops, Data Management and Vendors as appropriate).


Key Qualifications:

  • Life Sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. 
  • 7-10+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
  • Prior experience with clinical drug development operations, including strategic planning, budget forecasting, timeline and CRO management.
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/ or analysis of biological samples. 
  • Knowledgeable of lab vendors and analytical technologies in the field of neuroscience and autoimmune diseases highly preferable.
  • Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH, GCP, GLP highly preferable.
  • Strong analytical and problem-solving skills, ability to analyze complex activities and information to arrive at logical conclusions.
  • Demonstrated ability to think strategically and develop and execute biomarker/analytical operations strategies in a global setting.


Other:

  • Some travel may be required.


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, CMC

Research

Director/Senior Director, CMC

Job Description

Company Summary

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. 


Desired Candidate Profile

This position reports into the Vice President of CMC & Supply Chain Logistics. The Director/Senior Director will lead efforts to develop and manufacture drug substance and drug product and to track clinical drug inventory.


Specific Responsibilities:

  • Serves as a supporting contact to direct production activities at CMOs and provide technical support and troubleshooting. 
  • Collaborates with other functions at Annexon to develop and implement specifications for drug substance and drug product specifications, and if needed, collaborates with QA and other functions to manage out of specifications, deviations and investigations.
  • Participates with Clinical Operations to ensure that drug supplies are available on-time for support of clinical studies.
  • Author of and/or reviews batch records, change controls, and other technical documents.
  • Leads the development and validation of analytical methods according to ICH guidelines to ensure effective characterization and release of clinical batches.
  • Designs and oversees formulation development and stability studies for drug substance and drug product for multiple compounds.
  • Collaborates with QA, Regulatory Affairs and other functions towards timely generation of regulatory documents.
  • Collaborates with discovery project leaders to determine if a viable initial development pathway for initial development exists for molecules being considered as development candidates.


Key Qualifications 

  • 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.
  • 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.
  • Small molecule experience is preferred.



Apply Online

Medical Director/Senior Medical Director, Autoimmune (SSF, CA or Remote)

Development

Medical Director/Senior Medical Director, Autoimmune (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 Medical Director/Senior Medical Director, Autoimmune (SSF, CA or Remote) 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

Payroll & Equity Compensation Manager

General & Administrative

Payroll & Equity Compensation Manager

Job Description

Company Summary

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. 


Desired Candidate Profile

The Payroll & Equity Compensation Manager will be responsible for the full payroll function, including equity-based compensation, as well as developing and strengthening internal controls and processes related to payroll and equity. This role will be responsible for managing the Company’s equity compensation process, including option grants and the ESPP plan. The candidate will be responsible for the day-to-day operations and transactions as well as month-end accounting close as related to payroll and equity.  Ideal candidates will have a background working on both payroll and equity management in industry and the ability and desire to work in a fast paced and dynamic environment.  This individual will work closely to support all employees and across various functions including HR, Legal, payroll/benefits provider, transfer agent, broker, and financial auditors.


Specific Responsibilities

  • Responsible for ensuring accuracy, compliance, and timely processing of semi-monthly and  monthly payrolls for employees located in multi-state locations.
  • Review and process transactions including benefit changes, special compensation, other adjustments.
  • Coordinate with HR to process new hires, terminations, leaves, and other changes.
  • Resolve inquiries from employees in a timely and professional manner.
  • Ensure compliance with internal controls, federal/state/local requirements, deadlines.
  • Manage regulatory filings, notices, audits, and other communications from federal and state agencies.
  • Work with payroll vendor on system administration, maintenance, reporting needs.
  • Manage, reconcile, and report on employee benefit programs, including 401(k) and FSA, and work with service providers to resolve inquiries and/or provide employee training.
  • Prepare journal entries, payroll and benefit reconciliations, and assist with quarterly reporting and external financial audits.
  • Ad hoc projects including compensation research for annual compensation process and employee changes, board reports.
  • Prepare and process new equity awards, exercises, cancellations and releases promptly, including off-cycle payrolls for tax withholdings.
  • Track and report W-2 income from stock exercises and dispositions
  • Execute trading blackout periods and enforcement of insider trading policy restrictions.
  • Manage open enrollment process and purchases for ESPP including monitoring limits.
  • Interact with transfer agent to ensure that trades are settled timely.
  • Prepare journal entries related to equity and stock-based compensation expense, reconciliations, and assist with quarterly reporting and external audits.
  • Ad hoc projects, similar to above


Key Qualifications

  • Bachelor’s degree in Accounting or Finance
  • 7-10 years of relevant work experience, preferably in biotechnology industry
  • Elite attention to detail and accuracy
  • Professional, responsive and customer-focused working relationships with all levels of staff
  • Ability to clearly communicate verbally and in writing.
  • Positive team attitude with a willingness to work on both smaller and large tasks to help get the job done.
  • Candidate with experience in a fast-growing company is preferred.
  • Experience with TriNet, Computershare, Certent, and NetSuite preferred
  • Proficient in Microsoft Office, advanced Excel skills
  • Working knowledge of US GAAP, SOX, and SEC reporting requirements
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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.