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Director/Senior Director, Clinical Operations (Autoimmune)

Annexon Biosciences

Annexon Biosciences

Sales & Business Development, Operations
Posted on Friday, June 2, 2023

Director/Senior Director, Clinical Operations (Autoimmune)

Work Location

Corporate Headquarters (South San Francisco, CA)

Position Summary

The Director/ Senior Director, Clinical 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, Portfolio Strategy & Operations, Biostatistics, Regulatory Affairs, Research, Finance, Legal and HR. This position reports into the Chief Medical Officer.

Responsibilities

  • Lead and integrate Global Clinical Operations, Data Management, Global Strategic Clinical Outsourcing, Medical Writing, 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.

Key Qualifications

  • 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 highly desirable.
  • 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 ophthalmologic 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.

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. To learn more about our diversity commitment, culture and values, visit https://annexonbio.com/careers/
  • 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.

Compensation

The anticipated starting salary range for the Director, Clinical Ops position $209,700 to $233,000 per year; Senior Director, Clinical Ops position $256,500 to 285,000. 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 is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.

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 talentacquisition@annexonbio.com with the Subject Heading: Staffing Agency Request.