Sr. Medical Director/VP, Clinical and Translational Development
Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. 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 thecal 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.
Desired Candidate Profile
We seek a MD with extensive experience in Clinical or Translational Development to build and operationalize a Precision Medicine approach to support clinical development in Annexon’s auto-immune and neurology portfolio. Reporting to the Senior Vice President Translational Medicine, the successful candidate will bring deep scientific and therapeutic area experience with regards to early clinical development, interpreting biomarker results that help with effective project level decision making, and communicate effectively with senior management and teams in a highly matrixed environment. As a member of our translational research team, you will be a vital part of shaping our translational strategy and vision.
This position will work across research and development groups, collaborating with Clinical Biomarkers, Clinical Pharmacology and Nonclinical and Research, to ensure seamless execution of a biomarker-driven clinical development strategy. The candidate will be a key part of the team that provides strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated Precision Medicine strategy for assigned program(s). Level and compensation will be commensurate with experience.
- Primary accountability for selecting indication and trial design in collaboration with Research and Clinical Biomarkers to assess proof of target engagement, and/or pharmacodynamics activity, establish early signs of efficacy, enabling proof of concept studies, and understanding disease progression.
- Partner with Clinical Biomarkers to enable patient selection, biomarker and companion diagnostic strategies for projects across Annexon’s growing portfolio
- Support global regulatory strategy and contribute to the generation of investigator brochures, IND applications, clinical protocols and other regulatory documents as appropriate. Supports scientific input and review of all translational research aspects of clinical and regulatory documents, including but not limited to development plans, study protocols, clinical study reports, regulatory submissions and responses to any regulatory questions, etc.
- Provide domain area expertise to discovery and development project teams and further enhance Annexon’s scientific reputation through high impact publications and presentations
- Function as a scientific and business thought-leader inside and outside of the company and a key link to external community
- Work closely with research team members to understand evolving project portfolio, identify knowledge gaps related to target diseases, and prioritize resources needed for specific assets
- Partner with Clinical Biomarkers on biomarker-related internal studies, consortium work, or academic collaborations as needed
- Collaborate with Clinical Biomarkers to develop scientifically rigorous translational and exploratory biomarker strategies that assess proof of mechanism, establish early signs of efficacy, enable proof of concept studies, and generate an understanding of the variability in patient response
- Consult with project teams on biomarker discovery, strategic assessment of indications for clinical samples profiling and understanding of mechanism or disease related biology
- Lead drafting of clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.).
- Engage with Clinical leads, Biomarker and Clinical Operations for implementation of biomarker analyses in the clinic.
- May act as Medical Monitor, ensuring continuous evaluation of drug safety profile including safety monitoring of clinical studies
- An advanced degree (MD or non-US equivalent of M.D) with 10+ years industry expertise in a Translational Sciences discipline
- 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.)
- Rare disease experience is preferred
- Strong interpersonal, influencing and collaboration skills to work in a team-oriented, matrix environment, and the ability to work through conflicts
- Ability to apply a Precision Medicine approach to projects from pre-clinical through early clinical development
- In depth experience in the clinical implementation of innovative biomarkers and companion diagnostics
- Excellent management skills, including the ability to set high but reachable goals, define priorities, manage individual performance, and infuse the team with a sense of purpose and urgency
- Thorough understanding of clinical development and discovery research, and analytical and clinical validation of biomarker assays
- Familiarity with data management and visualization tools and collaborating with computational biology to analyze complex data sets emerging from clinical trials
- Excellent communication skills, ability to present results in clear and concise manner.
- Passion for developing new therapies
- Must be able to work under pressure, meet tight deadlines, multi-task and be able to pivot in response to changing priorities while maintaining a positive and collaborative attitude
- Residence in the bay area preferred
- Annexon’s Sr. Medical Director/VP, Clinical and Translational 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.