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Vice President, Clinical Development - Ophthalmology

Company: Aircall
Location: San Francisco
Posted on: April 9, 2021

Job Description:

Vice President, Clinical Development - Ophthalmology Annexon Biosciences is a clinical-stage biopharmaceuticalcompany developing a pipeline of novel therapies for patients with classicalcomplement-mediated disorders of the body, eye and brain. The Company'spipeline is based on its platform technology addressing well-researchedclassical complement-mediated autoimmune and neurodegenerative diseaseprocesses, both of which are triggered by aberrant activation of C1q, theinitiating molecule of the classical complement pathway. The Company's firstproduct candidate, ANX005, is a full-length monoclonal antibody formulated forintravenous administration in autoimmune and neurodegenerative disorders. TheCompany's second product candidate, ANX007, is a monoclonal antibodyantigen-binding fragment (Fab) formulated for intravitreal administration forthe treatment of neurodegenerative ophthalmic disorders. Based on learningsfrom its initial trials, Annexon is advancing its current programs whileevaluating additional orphan and large market indications. Annexon is deployinga disciplined, biomarker-driven development strategy designed to establish thateach of its product candidates is engaging the specific target at awell-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 byproviding strategic and operational leadership both cross-functionally and to ateam that they will build from the ground up. This role will entail thedevelopment, implementation, and oversight of a robust early developmentprocess for Ophthalmology-focused scientific initiatives-- within thecompany. The Vice President will be a core member of the clinical and medicalteam and will contribute to devising the overall clinical strategy and ensureall activities occur in compliance with the appropriate regulations. They willprovide support to translational medicine efforts within Ophthalmology, workingclosely with research and preclinical development to define strategy andtransition compounds from research into development candidates, and ensuretheir effective, timely de-risking while ensuring time- and cost-efficiency ofthe clinical development plan and clinical trial design. Responsibilities -- Lead the design and execution of clinical trials for ophthalmologyfocused diseases in collaboration with cross-functional partners -- Collaborate across all levels in the organization, includingeffective cross-functional interactions with R&D, program leadership, etc. -- Formulate clinical development plans (CDP) that integratescientific rationale, clinical need, clinical measurement approaches,statistical rigor, regulatory and payor requirements, and company strategy -- Develop and implement high quality clinical studies to support theCDP including biomarker and translational studies -- Provide medical monitoring, safety assessment, and overalloversight for all clinical trials within Ophthalmology -- Serve as a content expert in the review of abstracts,publications, medical information letters, and other medical documents asneeded -- Provide medical input into regulatory document preparation -- Lead content development for advisory board meetings -- Contribute to company success through both internal and externalmedical education and medical/scientific information exchange and support -- Build relationships with key external stakeholders including, butnot limited to healthcare professionals at key institutions, patient advocacygroups, and regulators by providing disease state education and communicatingthe clinical value of Annexon's scientific platform -- Drive a high-performance culture by fostering innovation, personalaccountability, and commitment for results Qualifications -- -- Ophthalmologist MD with 15+ years' experience,including at least five years of previous biopharmaceutical industry experience -- Expertise and awareness of the landscape in earlystage development in the Ophthalmology space -- Proven expertise in translational medicine andbiomarker development -- Experience executing and analyzingproof-of-concept studies to drive programs forward strongly preferred -- Understanding of adverse events and safetypackages preferred -- Ability to understand and effectively communicatescientific and medical information to both internal and external networks, insupport of the scientific and business strategy -- Demonstrated leadership skills and experiencebuilding effective teams -- Excellent written and oral communication skills -- Ability to anticipate and adapt to change -- Strong interpersonal skills commensurate with theneed to work closely with partners, investigators, contractors, consultants,and team members across functions -- Ability to communicate well with health careprofessionals; ability to establish strong relationships with peer groups,professional organizations, and other outside parties

Keywords: Aircall, San Francisco , Vice President, Clinical Development - Ophthalmology, Executive , San Francisco, California

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