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

CMC Operations Manager

Research

CMC Operations 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. 


Specific Responsibilities:

  • Manage CMC material resource allocation and planning to support project deliverables including coordinating shipments and import/export activities.
  • Assist with development and management integrated CMC timelines for Contract Manufacturing partners (CMOs) and internal CMC and QA teams for clinical product development, analytical development, and release of clinical batches.
  • Coordinate with Clinical Operations and Project Management to ensure up-to-date information on clinical study design, clinical study enrollment rate and timeline are available to support drug inventory planning and tracking across different projects.
  • Coordinate and facilitate CMC Team meetings and CMO meetings (regularly scheduled and ad hoc) by providing meeting agendas, minutes, and tracking action items.
  • Partner with Portfolio team to leverage Project Management tools and templates where applicable.
  • Develop and provide consistent project tracking and project reporting to CMC leadership and project teams.
  • Ownership of departmental budget development for CMC projects. Own and track purchase-to-pay activities to make sure project budget goals are met. 
  • Act as a liaison between CMC, CMO, and Legal groups to facilitate review and execution of contracts and business documents, including Master Service Agreement, Statement of Work, Change Order, and Confidentiality Disclosure Agreement.


Key Qualifications:

  • Undergraduate degree in a scientific, medical or business discipline; postgraduate qualifications (e.g., Ph.D., MBA, MS) or commensurate experience is a plus
  • Minimum 7 years’ pharmaceutical industry experience with some past experience with CMC
  • CMO/CRO management experience is desirable
  • Exceptional communication and organizational skills
  • Demonstrated ability to prioritize and plan realistic deadlines
  • Team-oriented, with excellent interpersonal skills (i.e. adaptable, flexible, collaborative).
  • Fluent in project management tools such as Excel, Project, and Smartsheet is required


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, 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
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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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Senior Director, Medical Affairs (SSF, CA or Remote)

Development

Senior Director, Medical Affairs (SSF, CA or Remote)

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 

Reporting into the Senior Vice President, the Sr Director Global Medical Affairs will be a core member of the global medical affairs team and will help to establish the Global Medical Affairs capabilities and function at Annexon Biosciences. This role will ultimately be responsible for representing Annexon Biosciences with a network of external thought leaders and driving Global Medical Affairs activities for assigned therapeutic areas.


Specific Responsibilities

  • Represent Medical Affairs on cross-functional Core teams, including sharing of clinical perspectives and evolving industry insights to inform strategic planning
  • Develop and manage a thought leader network to collect clinical insights and inform broader corporate initiatives
  • Engage with patient advocacy groups to identify and represent areas of unmet need for patients and families in strategic decision making
  • Work with clinical development teams to support inclusion of relevant clinical and outcome measures to inform needs of patients, physicians and payers
  • Provide medical/scientific expertise in support of development and review of content (slides, websites, FAQs) for medical communications and education to advance disease state and clinical understanding
  • Ensure alignment of the Medical Affairs activities with the core team plans and objectives.
  • Work closely with clinical development medical leads and medical communications to develop, submit and present clinical data at scientific congresses
  • Convey role of Annexon’s lead compounds in treating autoimmune and neurodegenerative diseases.
  • Work closely with cross-functional partners to understand current medical practice in the diseases of interest and what is needed to address the unmet needs from the clinical and health economics perspective. 
  • Develop and implement key medical affairs strategies and activities to support the late stage development of Annexon’s lead assets.
  • Contribute to company success through both internal and external medical education and medical/scientific information exchange and support.
  • Build relationships with key opinion leaders by providing disease state education and communicating the clinical value of Annexon’s scientific platform.


Key Qualifications

  • MD, DO, PhD and/or PharmD with 10+ years’ industry experience, including at least five years of previous biopharmaceutical industry experience 
  • Experience with prelaunch and diseases in autoimmune, ophthalmology and/or neurodegeneration desired
  • Ability to understand and effectively communicate clinical and scientific information to both internal and external networks, in support of the medical and corporate strategy 
  • Demonstrated strong track record of leadership and experience building effective teams 
  • Excellent written and oral communication skills 
  • Ability to anticipate and adapt to change 
  • Strong interpersonal skills commensurate with the need to work closely with partners, KOL’s, consultants, and team members across functions 
  • Ability to communicate well with health care professionals and patient advocates; ability to establish strong relationships with peer groups, professional organizations, and other external stakeholders 
  • Ability to travel up to 30% 


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Sr. Director/VP Project Team Leader

Development

Senior Director/VP, Project Team Leader

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. 

Position Summary 

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 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. The Project Team Leader will report into the SVP, Portfolio Strategy & Operations.


Specific 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 within the field of Neuroscience and/or 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.


Key Qualifications:

  • The successful candidate should have an advanced degree in life sciences or medicine (PhD or MD) and/or commensurate experience.  
  • They 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 direct Project Team Leader experience.
  • 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/Influencing:  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.  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.


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VP, Clinical Pharmacology

Development

VP, Clinical Pharmacology

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. 


Specific Responsibilities

  • Reporting to the CMO, responsibilities will span Annexon’s development programs, as well as exploratory studies to support evaluation of potential pipeline expansions.
  • Responsible to help set global and program specific clinical pharmacology strategy and execution thereof 
  • Build and lead a highly effective, innovative clinical pharmacology group that can facilitate data driven decision making in the clinic and can support regulatory requirements for safety and efficacy
  • Lead integration of preclinical and medical data analyses to guide development decisions
  • Lead and promote the use of leading-edge clinical pharmacology and model-based drug development (MBDD) approaches that maximize ability to make go/no go decisions
  • Support or lead, as possible, preparation of regulatory documents for health authority meetings, designations


Key Qualifications:

  • PhD (or MD) in a drug development-related disciple with 15+ years of experience in the pharmaceutical or biotechnology industry, with 10+ years of direct experience in nonclinical development and Clinical pharmacology expertise.  
  • Large company pharmaceutical experience preferred.
  • A broad understanding of drug development as evidenced by a track record of significant contributions to successful patents, INDs, Regulatory Agency interactions, NDAs, drug approvals, in-licensing deals, and peer reviewed publications.
  • Proven ability to build and lead an excellent nonclinical development / clinical pharmacology function, ideally with extensive outsourcing components and including organizational design and the recruitment, development and retention of first-rate personnel.
  • Comfortable in an entrepreneurial organization, wherein all leaders must take a hands-on approach and the environment is fast-paced and challenging.
  • Residence in the SF Bay Area is preferred 


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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.