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.
Reporting into the Chief Medical Officer, the Vice President, Ophthalmology Development will be responsible for driving Annexon’s growth by providing strategic and operational leadership both cross-functionally and to a team that they will build from the ground up. This role will entail the development, implementation, and oversight of a robust early development process for Ophthalmology-focused scientific initiatives within the company.
The Vice President will be a core member of the clinical and medical team and will contribute to devising the overall clinical strategy and ensure all activities occur in compliance with the appropriate regulations. They will provide support to translational medicine efforts within Ophthalmology, working closely with research and preclinical development to define strategy and transition compounds from research into development candidates, and ensure their effective, timely de-risking while ensuring time- and cost-efficiency of the clinical development plan and clinical trial design.
· Lead the design and execution of clinical trials for ophthalmology focused diseases in collaboration with cross-functional partners
· Collaborate across all levels in the organization, including effective cross-functional interactions with R&D, program leadership, etc.
· Formulate clinical development plans (CDP) that integrate scientific rationale, clinical need, clinical measurement approaches, statistical rigor, regulatory and payor requirements, and company strategy
· Develop and implement high quality clinical studies to support the CDP including biomarker and translational studies
· Provide medical monitoring, safety assessment, and overall oversight for all clinical trials within Ophthalmology
· Serve as a content expert in the review of abstracts, publications, medical information letters, and other medical documents as needed
· Provide medical input into regulatory document preparation
· Lead content development for advisory board meetings
· Contribute to company success through both internal and external medical education and medical/scientific information exchange and support
· Build relationships with key external stakeholders including, but not limited to healthcare professionals at key institutions, patient advocacy groups, and regulators by providing disease state education and communicating the clinical value of Annexon’s scientific platform
· Drive a high-performance culture by fostering innovation, personal accountability, and commitment for results
· Ophthalmologist MD with 15+ years’ experience, including at least five years of previous biopharmaceutical industry experience
· Expertise and awareness of the landscape in early stage development in the Ophthalmology space
· Proven expertise in translational medicine and biomarker development
· Experience executing and analyzing proof-of-concept studies to drive programs forward strongly preferred
· Understanding of adverse events and safety packages preferred
· Ability to understand and effectively communicate scientific and medical information to both internal and external networks, in support of the scientific and business strategy
· Demonstrated leadership skills 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, investigators, contractors, consultants, and team members across functions
· Ability to communicate well with health care professionals; ability to establish strong relationships with peer groups, professional organizations, and other outside parties
· Ability to travel up to 20%