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.
Annexon Biosciences is seeking a proven clinical sciences leader who will lead projects across the Annexon portfolio.
Reporting into the Head of Autoimmunity Development and Clinical Pharmacology and Bioanalytical Sciences, the Director/Senior Director, Clinical Development will lead the design and execution of one or more clinical studies and will provide medical, scientific, and operational guidance to cross-functional study teams. These strategies are critical to Annexon’s integrated approach in the key therapeutic areas of Autoimmune diseases, Neuroscience and Ophthalmology. This individual will serve as an important Annexon leader and integrator across clinical development and will apply support and oversight across the portfolio. The Director – Senior Director Clinical Development will also be responsible for helping the team to integrate safety data across multiple studies for investigational agent(s).
· Accountable for design, planning, and execution of clinical development programs
· Provide leadership, clinical and scientific expertise, and consultation to preclinical and clinical programs across all stages of development
· Clinical support and oversight and overall responsibility for monitoring study conduct and safety while relying upon sound judgment
· Author relevant sections of study/program level documents (e.g. clinical protocols, investigator brochures, case report forms, safety updates, submission dossiers, and regulatory interactions) and abstracts/publications for external communication
· Independently perform data analysis, interpretation, integration, and reporting, and/or oversee vendors responsible for this and communicate findings to internal/external stakeholders
· Interface with clinicians/investigative sites for protocol related interpretation and clarification, determination of study participant eligibility, and issues of participant safety
· Contribute to regulatory filings (e.g. BLA, NDA); prepare relevant sections of regulatory documents and serve as clinical representative for communications with regulatory agencies
· Provide clinical and scientific guidance to internal/external partners
· Liaise with clinical and scientific key opinion leaders in the field related to assigned programs and therapeutic area(s)
· Support growth, process, and capability development for a growing the clinical development organization in a dynamic and team-orientated environment
· Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidances
· MD, DO, or non-US equivalent of MD degree, PhD, PharmD, MS, or nursing background with a minimum of 5 years of relevant biotechnology or pharmaceutical industry experience in clinical development, medical affairs, or pharmacovigilance.
· Clinical trial design and management experience required
· Regulatory communication experience preferred
· Understanding of regulatory approval processes (US and ex-US, IND/CTA and BLA/MAA)
· Must be a highly flexible, results- and detail-oriented, independent self-starter who enjoys working in a fast-paced and dynamic, team-oriented environment
· Excellent collaboration, communication, and interpersonal skills are required to engage and be productive within a high-achieving team environment
· Ability to proactively evaluate issues and solve problems
· Proven clinical leadership expertise (working in teams, managing internal and outsourced projects)
· Strong verbal, writing, presentation, and editing skills
· Ability to operate independently in a matrixed organization
· Strong knowledge of global regulatory requirements, GCP, and ICH guidelines
· Residence in the SF Bay Area is preferred