Annexon Biosciences

Role Description Reporting to the Head of Statistical Programming, this individual independently operates and oversees the development and delivery of statistical programming solutions for all Annexon clinical trials and regulatory submissions. A highly visible and collaborative role, the Associate Director of Statistical Programming partners cross-functionally to advance medicines to our patients. - Manage timelines and provide sponsor oversight for statistical programming deliverables outsourced to biometrics vendors (CROs) with full E2E traceability. - Serve as lead statistical programmer on one or more clinical studies. - Conduct gap analysis and risk assessments for global submissions such as BLA/MAA etc. - Review SAP, TFL shells, eCRFs etc. - Maintain complete and auditable documentation for all statistical programming activities. - Develop and/or verify CDISC SDTM/ADaM specifications, datasets and eCRT submission packages such as define.xml, reviewer’s guide’s etc. - Support supplemental/ad hoc/post hoc requests for submissions, publications and manuscripts. - Provide guidance to project/study teams. - Participate cross-functionally with key partners to advance Annexon products. - Contribute to and participate in the development and maintenance of a positive team-focused company culture. Qualifications - MS with 8+ years of experience or BS with 10+ years of experience in the pharmaceutical or biotechnology industry in a Statistical Programming leadership capacity. - In-depth knowledge of CDISC standards. - Prior FDA and EMA submissions experience. - Technical expertise and knowledge of experimental design and analyses using statistical software such as SAS etc. - Understanding of GCP, ICH, 21 CFR Part 11 standards. - Work in dynamic, demanding and collaborative environment. Requirements - Ability to communicate with clarity and influence including explaining complex quantitative issues in simple terms. - Solid understanding of Regulatory (FDA/EMA/ICH) guidance with the ability to interpret and apply in real-time drug development setting. - Understanding of regulatory submission and approval process. - Ability to effectively collaborate and influence throughout multiple levels of the organization. - Strategic and creative drug-development mindset/approach. - Ability to balance appropriate levels of structure/process with efficiency and simplicity. - Aware of external industry landscape with respect to best practices and emerging topics. 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. - Competitive base salary and equity participation. - Employee stock purchase plan. - Comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

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, Huntington’s 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, you’ll 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. We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! Position: We are seeking an accomplished and visionary leader to join our team as Vice President, Clinical Development-Ophthalmology. The Vice President, Clinical Development-Ophthalmology will play a critical role in shaping and executing our ophthalmology strategy, serve as the clinical leader for Annexon’s ophthalmology portfolio, including late-stage programs such as Vonaprument including data readout, interpretation, communication, submission, approval, and commercialization of vonaprument for the treatment of geographic atrophy. This role requires a seasoned professional with deep expertise in ophthalmology, particularly in retinal diseases, and drug development within this therapeutic area, possessing strong leadership skills, and a track record of success in bringing innovative therapies to market. The Vice President, Clinical Development-Ophthalmology will be responsible for driving the clinical strategic direction of our vonaprument franchise working collaboratively with key team leadership. Like all Annexon leaders, the Vice President, Clinical Development-Ophthalmology 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: Drug Development: - Lead the medical/clinical oversight of the Phase 3 program including: communication with sites throughout the study in collaboration with the Medical Affairs team, review and interpretation of all clinical data, and communication of results in scientific and informal venues - Medical authorship and ensuring the integrity and quality of abstracts, manuscripts, study reports, and regulatory communications and documents, and site or safety (in collaboration with pharmacovigilance) communications - Serve as the clinical expert developing the life cycle management plan for vonaprument including an open-label extension study, subset identification, extended dosing, and expanded indications; lead in the preparation of phase 4 clinical studies for these objectives - Interactions with Key Opinion Leaders to education and advance the field on the benefit afforded by vonaprument based on its unique mechanism of action - Identify core objectives for the design and implementation of the clinical development strategy including an open label extension and, in collaboration with Medical Affairs, Phase 4 clinical studies that support the development, registration, and commercialization of vonaprument - Represent Annexon and the vonaprument program for external engagements with CRO’s, consultants, sites, etc. - In collaboration with Clinical Operations, oversee the execution of clinical trials, ensuring compliance with regulatory requirements, ethical standards, and timelines as well as support for Medical Monitoring activities - Serve as the Ophthalmology Lead for the development team, partnering closely with the Program Team Leader, heads of development operations, clinical operations, pharmacovigilance, clinical quality, and biometrics - Provide the primary authorship for key clinical sections of marketing authorization submissions (e.g., BLA, MAA, etc.). - Provide medical leadership for issue identification/resolution, and data quality - Support for business development activities in Ophthalmology Strategic Leadership: - Serve as a member of the vonaprument Core Team and Development Leadership Team to support the creation and execution of a strategic plan for vonaprument, in collaboration with team members, the Program Team Leader, and functional leadership - Leverage scientific and clinical expertise to guide decision-making and optimize execution and data interpretation - Leadership role in collaboration with Medical Affairs for KOL engagement, Advisory Committee interactions, and Steering Team meetings - Drive innovation and differentiation of vonaprument through the deep and complete understanding of current and future data generated for the program - In collaboration with Regulatory Affairs and vonaprument Program team, develop and execute robust regulatory strategies for the program - Interface with regulatory authorities to facilitate successful regulatory submissions and approvals - Stay abreast of evolving guidelines and requirements for ophthalmic drug development Cross-Functional Collaboration: - Foster strong collaboration and alignment across functions, including R&D, clinical development, regulatory affairs, commercial, and other relevant departments. - Serve as a key liaison between the ophthalmology team and executive leadership, providing regular updates on portfolio progress and strategic initiatives. - Cultivate a culture of teamwork, innovation, and accountability within the ophthalmology organization. Education, Experience, and Skills: Required: - Medical Degree with subspecialty training and practice in Retina and MD or MD/PhD with deep experience in the field of Ophthalmology required - 15 – 20 + years of experience in the pharmaceutical or biotechnology industry, with a focus on ophthalmology drug development - Prior experience as a VP in Clinical Development strongly preferred - Proven track record of leadership in ophthalmology, including successful development and commercialization of ophthalmology products. - In-depth understanding of ophthalmic diseases, drug development processes, and regulatory requirements. - Demonstrated ability to develop and execute strategic plans, drive innovation, and deliver results in a fast-paced, dynamic environment. - Strong leadership and interpersonal skills, with the ability to inspire and influence teams at all levels of the organization. - Excellent communication and presentation skills, with the ability to effectively articulate complex scientific and clinical concepts to diverse audiences. - Experience interacting with regulatory authorities and leading successful regulatory submissions and approvals. - Business acumen and strategic thinking, with a focus on maximizing the commercial potential of ophthalmology products. Preferred: - Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting. - Familiarity with emerging trends in ophthalmology, including cutting-edge therapeutic modalities. Salary Range: $399,600 – $427,500 USD Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area. 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.

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, Huntington’s 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, you’ll 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. We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! Position: The Field Medical Directors (FMDs) are medical experts who are an extension of the Medical Affairs team and represent Annexon with key stakeholders. They engage with national, regional, and local scientific, clinical, and social thought leaders (TLs) at academic and community medical centers as the scientific and medical expert on Annexon’s products and areas of research. This role will develop and maintain professional relationships with TLs based on scientific exchange of disease and Annexon product data. Responsibilities include: - Develop and maintain professional relationships with Thought Leaders (TLs) through compliant scientific exchange via two-way communication inclusive but not limited to pathogenesis of Therapeutic Areas (TA) of interest to Annexon, diagnosis, disease burden, treatment landscape, health economics, and relevant Annexon product data in line with medical affairs and Annexon strategy - Collaborate with TLs on research projects, national and regional advisory boards, visiting professorships, publications, and peer-to-peer educational initiatives - Develop and maintain the highest scientific and medical expertise in neurologic diseases, trials and treatment landscape with a patient centric mindset - Identify potential high-impact medical research projects, investigator-initiated research, health-economic trials, and publication opportunities in line with Annexon TAs of interest - Be acknowledged internally and externally as a trusted Scientific expert and build lasting professional relationships with TLs and Centers of Excellence & Research (COERs) - Attend local, regional, national, international meetings and congresses as needed to engage in Scientific exchange, capture scientific insights, share data on Annexon products and TAs, and identify areas for collaboration with TLs - Respond to healthcare professionals (HCPs) with integrity, a sense of urgency, adherence to all laws, regulations, and Annexon guidelines, policies & procedures - Partner with Patient Advocacy Organizations in a compliant manner to integrate the patient voice into scientific and medical communications - Deliver education on Annexon’s science and product data to P&T committees, formulary decision makers, and local, regional and national payers in accordance with all laws, regulations, and Annexon’s guidelines, policies, and procedures, while aligning with medical affairs and Annexon’s overall strategy - Develop and execute tailored TL and HCP scientific engagement plans as needed - Engage with TLs, trial investigators, and research staff, to support Clinical Development and Clinical Operations activities including but not restricted to identification of viable study sites, facilitation of participation in clinical trials, and patient recruitment - Ensure strong, compliant collaboration with cross-functional field partners - Serve as the Medical Expert and a field representative for Medical Directors with TLs, investigators, and other cross-functional partners Education, Experience, and Skills: Required: - Scientific, healthcare or medical degree (PharmD, PhD, MD, DO) - FMD requires 4 to 6 years of field-based experience in biopharmaceutical industry in medical affairs or relevant clinical roles and FMSD requires 6+ years of experience - Scientific and patient-centric mindset with a successful track record of delivering results exceeding objectives in support of medical affairs and Annexon strategies - Strong communication and presentation skills as evidenced by the ability to rapidly analyze complex scientific and medical data and synthesize for effective communication to audiences with diverse backgrounds - Demonstrated ability to build scientific relationships with TLs, clinicians, researchers, and other relevant internal or external stakeholders - Able to effectively collaborate within a matrix organization and cross functional teams - Solid knowledge of the healthcare landscape inclusive but not limited to hospital systems, various points of care, and the roles of relevant HCPs in the target TAs - Solid knowledge of the drug development process, and the role of various internal and external stakeholders in various phases of R&D - Able to document insights, TL engagement and complete all administrative tasks in a timely fashion - Capable of working independently to prioritize tasks, develop and implement action plans, and make sound, compliant decisions - Strong understanding of compliance, and the legal and regulatory landscape as they relate to HCP interactions - Flexible to travel within assigned region based on business needs and occasionally nationally or internationally Preferred: - Experience in medical affairs and/or clinical R&D preferred - Therapeutic area experience in neurology/neuromuscular and immunology preferred Location: Central Plains Region / Remote Field Based (includes onsite travel to Annexon – HQ) Level: This role may be filled at the Associate Director or Director level, depending on the candidate’s experience and qualifications Salary Range: ($190,000 - $224,000) 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.

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, Huntington’s 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, you’ll 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. We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! Position: The Vice President, Market Access will define and lead Annexon’s global market access strategy to support the successful launch and commercialization of the company’s therapies. This senior leader will be responsible for pricing strategy, payer engagement, reimbursement, patient services, and distribution strategy to ensure optimal patient access and sustainable product value. As a key member of the Commercial Leadership Team, the VP will partner closely with Commercial, Medical Affairs, HEOR, Regulatory, and Clinical Development to shape evidence generation and value propositions that support payer adoption and reimbursement. This role will play a critical role in preparing Annexon for launch and building the market access infrastructure required to support a growing commercial organization. Responsibilities include: - Develop and implement a comprehensive market access strategy, including pricing, reimbursement, and payer engagement, to support the launch and lifecycle management of Annexon’s products. - Lead cross-functional development of payer value propositions, access strategies, and evidence plans to support successful product launches - Lead the development of pricing strategies that reflect the value of Annexon’s therapies, considering market dynamics, payer requirements, and patient access. - Build and maintain relationships with key payers, including government and private insurers, to secure favorable coverage and reimbursement terms. - Lead the development and execution of distribution and channel strategies to ensure timely, compliant, and efficient delivery of products to customers and patients. - Work closely with Commercial, Medical Affairs, HEOR, Clinical Development, and Regulatory teams to ensure market access strategies are aligned with clinical and commercial goals. - Lead the execution of market access initiatives, including the development of market access tools, reimbursement support programs, and payer marketing materials. - Ensure all market access activities comply with relevant regulations and industry standards, including pricing and reimbursement policies. - Build, mentor, and lead a high-performing market access team, fostering a culture of innovation, collaboration, and excellence. - Educate internal and external stakeholders on market access challenges and opportunities, providing strategic insights to guide decision-making. Education, Experience, and Skills: Required: - Bachelor’s degree in Business, Health Economics, Public Health, or a related field. - 15+ years of experience in market access, pricing, reimbursement, or related roles within the biotech or pharmaceutical industry, with at least 7 years in a leadership role. - Demonstrated experience leading market access strategy for first product launches in specialty or rare disease markets. - Extensive knowledge of U.S. and global market access environments, including payer systems, pricing strategies, and reimbursement processes. - Proven experience in launching and securing market access for specialty and rare disease therapies. - Strong understanding of health economics and outcomes research (HEOR) and its application in market access strategies. - Excellent strategic thinking and problem-solving abilities. - Strong leadership and team management skills. - Outstanding communication and negotiation skills. - Ability to work collaboratively across teams and departments. - Proficiency in data analysis and the use of market access tools and technologies. Preferred: - An advanced degree (e.g., MBA, MPH) is strongly preferred.   Salary Range: $312,000 - $350,000 Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area. This position may be on-site or remote (within the US). 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.