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.

 The Sr. Vice President, Global Development Operations will be responsible for leading and integrating key operational functions within Development and will participate in the development and implementation of clinical strategies in collaboration with other functional leaders in Clinical Development, Clinical Operations, Portfolio Strategy & Operations, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Research, Finance, Legal and HR. This position reports into the Chief Medical Officer.

 

Primary Responsibilities

 

  • Lead and integrate Clinical Operations, Data Management and Pharmacovigilance functions across Annexon’s Development portfolio with accountability for allocating resources, development, mentoring, management and training of a high performing team.
  • Act as primary Development Operations interface with functional heads across Development and the rest of the organization to optimize planning efforts and communication.
  • Based on deep experience, provide strategic and operational leadership on the direction, planning, execution and interpretation of clinical trials at all stages.
  • Build a powerful capability for planning and modeling clinical trial timelines, enrollment assumptions, costs and generating feasibility data; Establish best practices for defining, tracking and responding in real time to clinical trial metrics for optimized operational performance and efficiency.
  • Develop a strategic and consistent approach for the selection and management of clinical study sites and external vendors (CROs) that support the clinical programs.  
  • Oversee all data management activities including case report form design, data tracking and generation; successfully manage multiple data read-outs for open label and blinded studies.
  • Partner with leadership of internal functions including Research and Translational Medicine to ensure optimization of clinical trial biomarker sample management and operations to meet key and frequent data deliverables across portfolio.
  • Lead and provide overall guidance on pharmacovigilance activities to ensure effective operations, risk management, and clinical trial safety surveillance, including review and oversight of all safety reporting, inclusive of clinical safety signal detection and assessment.
  • Collaborate with Regulatory Affairs to support regulatory strategy and delivery of written content and data for submissions; Ensure alignment of data output activities in collaboration with the Medical Writing department to enable the timely and high-quality completion of Clinical Study Reports, Investigator’s Brochures, Integrated Summaries, etc.
  • Collaborate with HR and Finance teams to assess, plan and manage human and financial resources consistent with the corporate operating plan and ensure support.
  • Partner closely with Legal team to ensure that vendor and clinical site contract review processes and workflow are optimally managed.
  • Ensure that appropriate capabilities, infrastructure, systems, standards and processes are in place to support execution of Development activities.

 

Requirements

  • At least 20 years of related experience with 10 years in leadership roles in the biopharmaceutical industry.
  • Minimum of a B.S./B.A. degree in a relevant scientific discipline; advanced degree (PhD or MD) or commensurate industry experience. 
  • Extensive experience as a hiring manager with a proven track record for attracting talent, building and maintaining strong teams.
  • Experience managing early- and late-phase clinical studies is required; proven track record of execution and oversight of successful clinical studies (delivered on time, within budget, and with high quality).
  • Extensive expertise in developing operational strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operational, regulatory, quality and legal aspects).
  • Strong therapeutic area knowledge and the ability to support the design and execution of clinical programs, preferably in the autoimmune, neurodegenerative and/or ophthalmic disease areas.
  • Experience leading and overseeing clinical trial-related pharmacovigilance activities to ensure compliance with all globally applicable laws and regulations as appropriate and local and foreign regulatory reporting requirements.
  • Extensive familiarity with all aspects of clinical Data Management requirements, including a working knowledge of related Biostatistics and Programming principles.
  • Experience managing relationships with external medical and scientific organizations.
  • Proven ability to work and lead effectively in a highly collaborative team environment with an emphasis on problem-solving.
  • Strong relationship management and leadership skills; strong ability to collaborate with the executive and management teams. 
  • Proven track record of experience working with contract resource organizations, functional service providers and third-party vendors; strong contract negotiation abilities and thorough understanding of all financial aspects of contracts.
  • Highly effective communicator with excellent writing and presentation skills.