Vice President, Translational Medicine

Company:

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body brain and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome Huntingtons disease and geographic atrophy we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon youll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane CA.

Were seekingexceptional talent from all backgrounds to fuel our growth. At Annexon were building a diverse equitable and inclusive workplace. We value unique perspectives and unconventional paths. If youre the best candidate for the job even if you dont perfectly fit the traditional mold we encourage you to more about our commitment to diversity equity inclusion and our companyculture!

Position:

We are seeking an accomplished experienced and creative development leader to join our team as Vice President Translational Medicine. The VP Translational Medicine will play a critical role in shaping and executing Annexons translational strategy across our portfolio of classical complement biology programs spanning diseases of the body brain and eye.

This position will serve as a key scientific and strategic partner to Clinical Development Discovery Regulatory Clinical Operations and Medical Affairsensuring that mechanistic hypotheses are translated into human biology evidence biomarker strategies and data-driven decision-making to accelerate development. The VP Translational Medicine will lead translational planning and execution for flagship and next-wave programs including tanruprubart (ANX005) in Guillain-Barré syndrome (GBS) vonaprument (ANX007) in dry AMD with geographic atrophy (GA) neurodegenerative programs including Huntingtons disease and ALS and acute indications such as traumatic brain injury (TBI) and myasthenic crisis.

This role requires a seasoned leader with deep expertise in translational medicine biomarker strategy assay development bioinformatics statistics and clinical developmentideally with strong domain experience in neurology ophthalmology and/or immunology/rheumatologyand a track record of building and leading high-performing translational organizations within pharma or biopharma. Like all Annexon leaders the VP Translational Medicine incumbent will have a deep-rooted commitment to serving patients and a passion for transforming the lives of people with serious diseases and their families.

Responsibilities include:

• Serve as the Translational Medicine Lead across Annexon programs setting an integrated portfolio-level strategy that links mechanism of action to clinical outcomes in complement-mediated diseases of the body brain and eye
• Partner with Program Team Leaders Clinical Development leads and program teams to define translational hypotheses proof-of-mechanism and proof-of-concept strategies and key decision criteria for each stage of development
• Provide leadership for translational prioritization resource planning and execution in a fast-paced dynamic environment consistent with a lean biotech operating model
• Build and lead a high-performing Translational Medicine organization spanning biomarker science translational bioinformatics/omics assay development/operations and sample/data strategy

• Develop and execute biomarker strategies to demonstrate:
• Target engagement and pathway modulation (e.g. classical complement pathway/C1q biology)
• Pharmacodynamic effects and dose/interval rationale
• Patient stratification and enrichment approaches
• Disease biology progression and treatment response
• Guide biomarker integration into clinical protocols across neurology and ophthalmology programs including fluid biomarkers imaging endpoints functional measures and exploratory omics.
• Oversee the development qualification and fit-for-purpose validation of translational assays (internal and external) including vendor selection governance and quality oversight.
• Lead translational interpretation and integration of multi-modal datasets (clinical biomarkers imaging omics) working closely with Biometrics and Data Sciences to enable actionable insights.

• Provide translational leadership for:
• GBS: tanruprubart (ANX005) an IV anti-C1q monoclonal antibody designed to inhibit the classical complement pathway
• Ophthalmology/GA: vonaprument (ANX007) an intravitreal Fab designed to locally block C1q in the eye while preserving other complement pathway activity
• Neurodegeneration: programs including Huntingtons disease and ALS leveraging C1q biology and neuroinflammation/synaptic injury frameworks
• Acute Injury/Functional Decline: programs including traumatic brain injury or myasthenic crisis
• Autoimmune Neuromuscular: programs including myasthenia gravis multifocal motor neuropthy chronic inflammatory demyelinating polyneuropathy (CIDP) and others
• Ensure translational strategies are aligned with clinical endpoints regulatory expectations and differentiation objectives including competitive landscape awareness and scientific positioning

• In collaboration with Regulatory Affairs and Clinical Development contribute to translational sections of regulatory documents and briefing packages (e.g. IND/CTA updates BLA/MAA modules as appropriate) supporting robust scientific rationale and biomarker justification
• Provide scientific leadership and oversight for abstracts manuscripts and study reports to ensure quality integrity and clarity of translational evidence
• Represent Annexon for external engagements with KOLs academic collaborators consortia CROs and scientific meetings; help educate and advance the field regarding Annexons approach to classical complement biology

• Foster strong collaboration and alignment across functions including Discovery Translational Sciences Clinical Development Clinical Operations Biometrics Regulatory Affairs Medical Affairs and Commercial.
• Serve as a key liaison between Translational Medicine and executive leadership providing regular updates on biomarker strategy human biology learnings and program implications.
• Cultivate a culture of teamwork innovation accountability and high scientific standards across the translational organization.

Education Experience and Skills:

Required:

• MD PhD or MD/PhD required; advanced clinical/scientific training strongly preferred.
• Minimum of 15 years of experience in pharma or biopharma with leadership responsibility in Translational Medicine Biomarkers and/or Clinical Development interfaces.
• Proven track record leading translational medicine organizations (strategy execution) including building teams developing biomarker plans and influencing clinical development decisions.
• Deep domain expertise in one or more of the following required; experience in Immunology/Rheumatology greatly preferred as well as experience across multiple areas:
• Immunology/Rheumatology (autoantibody biology complement-mediated disease)
• Neurology / Neuroimmunology (e.g. peripheral neuropathies neuroinflammation neurodegeneration)
• Ophthalmology (retinal disease drug development; imaging/functional endpoints)
• Demonstrated expertise in translational disciplines including biomarker strategy assay development/qualification clinical sample strategy/operations and translational data integration (including multi-omic and imaging datasets).
• Experience partnering with Regulatory Affairs and interacting with regulatory authorities in support of biomarker or translational strategy; experience supporting successful filings is a plus; experience with companion diagnostic development desirable
• Strong leadership and interpersonal skills with the ability to inspire and influence cross-functional teams at all levels of the organization.
• Excellent communication and presentation skills with the ability to clearly articulate complex scientific and clinical concepts to diverse audiences.
• Business acumen and strategic thinking with a focus on maximizing clinical differentiation and long-term value creation through human biology evidence.

Location: Annexon Biosciences is located in Brisbane California and preference is given to candidates in the San Francisco Bay Area.

Salary Range: $310000 $340000

Benefits:

• A stimulating and rewarding workplace includes flexible work schedules remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation employee stock purchase plan as well as a comprehensive health benefit package that includes medical dental vision 401(k) flexible spending plans and other benefits.

Annexon Biosciences is an Equal Opportunity Employer and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths views and experiences. We believe that our differences enable us to be a better team one that makes better decisions drives innovation and delivers better business results. Creativity and innovation flourish in an environment of openness inclusion and mutual respect.