Medical Director, Ophthalmology - Brisbane, United States - Annexon, Inc.

Description

Medical Director, Ophthalmology (Senior Director/ED/ VP)

Work Location

Corporate Headquarters (South San Francisco, CA) Onsite - Hybrid

Non-local candidates will be considered

Position Summary

The Medical Director, Ophthalmology will play a critical role in helping to shape and execute our ophthalmology strategy, serving as part of the ANX007 Core Team, taking a leadership role in the clinical/medical aspects of the Phase 3 program as well as the medical components of the submission, approval, and commercialization of ANX007 for the treatment of geographic atrophy.

This role requires a seasoned professional with deep expertise in ophthalmology and drug development within this therapeutic area, possessing strong leadership skills, and a track record of success in bringing innovative therapies to market.

The Medical Director, Ophthalmology will work closely with the VP, Ophthalmology - Clinical Development and help support the clinical strategic direction of our ANX007 franchise working collaboratively with key team leadership.

Like all Annexon leaders, the Medical Director, 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.

Key Responsibilities


Drug Development:

• Lead the medical/clinical oversight of the Phase 3 program including: medical monitoring, review and interpretation of clinical data, and communication with sites
• 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
• Identify core objectives that lead to the design and implementation of the clinical development strategy and protocols to support the clinical development, registration, and commercialization of ANX007
• Represent Annexon and ANX007 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 all 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 biostatistics
• Provide medical leadership for site selection, feasibility, enrollment, issue identification/resolution, and data quality
• Support for business development activities in Ophthalmology
• Serve as a member of the ANX007 Core Team and Development Leadership Team to support the creation and execution of a strategic plan for ANX007, in collaboration with team members, the Program Team Leader, and functional leadership
• Leverage scientific and clinical expertise to guide decision-making and optimize study design and execution
• Leadership role in collaboration with Medical Affairs for KOL engagement, Advisory Committee interactions, and Steering Team meetings
• Drive innovation and differentiation of ANX007 through the deep and complete understanding of current and future data generated for the program
• In collaboration with Regulatory Affairs and ANX007 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 regulatory guidelines and requirements pertinent to 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.

Qualifications:

• Advanced degree in life sciences, pharmacy, medicine, or related field. Medical Degree with subspecialty training and practice in Ophthalmology, Retina or and MD or PhD with deep experience in the field of Ophthalmology strongly preferred
• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with a focus on ophthalmology drug development.
• 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.

Compensation

The anticipated starting salary range for the Medical Director, Ophthalmology position is $269,000 - $299,000 per year. The anticipated starting salary range for the Senior Medical Director, Ophthalmology position is $320,000 - $355,000 per year. The anticipated starting salary range for the Executive Medical Director, Ophthalmology position is $340, ,000 per year.

The starting salary for this position will be determined based on the candidate's education, experience, transferable skills, licenses/certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation.

The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.

Company Summary

Annexon Biosciences (Nasdaq:
ANNX) is 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.

Annexon's 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, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible.

To learn more visit

What Annexon offers

• Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. We continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented candidates have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate. To learn more about Annexon's diversity commitment, culture and values, please visit
• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• We are located in Brisbane, CA, with 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, as well as other benefits.

EEO Employer - Annexon highly values Diversity, Equity, Inclusion and Belonging

Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status.

We are proud to promote a work environment where everyone, from any background, can do their best work.

Staffing Agencies

Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences.

Please do not send agency CVs/resumes through Annexon's website or Annexon Employees.

Inquiries must be sent to with the Subject Heading:
Staffing Agency Request.

Apply

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.