VP, Clinical Development - (SSF, CA or Remote)
VP, Clinical Development - (SSF, CA or Remote)
Annexon Biosciences is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with cal complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain, and eye. The company’s pipeline is based on its platform technology addressing a broad spectrum of well-researched cal complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the cal complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entirecal complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio.
Desired Candidate Profile
The Vice President, Clinical Development will be responsible for driving Annexon’s growth by providing strategic and operational leadership both cross-functionally and to a team that s/he will build from the ground up. This role will entail the development, implementation, and oversight of a robust early development process for immunology-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. S/he will provide support to translational medicine efforts within immunology, 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 Autoimmune Hemolytic Anemias, Lupus Nephritis (LN) and other immunological 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 Immunology
- 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
- MD required with Immunology or Rheumatology, Hematology Fellowship; Board Certification or Board-eligible in Immunology with 10+ years pharmaceutical development expertise.
- Demonstrated ability to work effectively with colleagues from multiple cultures, backgrounds, and geographies
- Demonstration of strong leadership and influencing skills with cross-functional and product development teams
- Demonstrated ability to develop and execute strategy across multiple functional areas
- Experience with early (IND-enabling efforts) and late-stage (BLA/NDA-enabling efforts) clinical development programs
- Ability to run a complex clinical research program with minimal direction
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
- Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team oriented and decisive
- Able to lead through influence
- Ability to effectively communicate project status, science, and strategy to a wide variety of internal audiences (researchers, development staff, peers throughout the company, management, executives, and whole company)
- External communication with industry scientists and/or regulators through conference presentations, publications, working groups, investigator meetings, and regulatory interactions
- Knowledge of requirements and expectations for regulatory milestones in relevant jurisdictions (IND, EOP1, pre-BLA, PIP, BLA/MAA, etc.)
- Ability to travel up to 20%
- Residence in the San Francisco Bay Area preferred
Annexon’s VP, Clinical Development will be required to be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.