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 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.
Desired Candidate Profile
We are looking for an individual to lead and champion Biomarker Operations across multiple therapeutic areas and franchises at Annexon. The successful candidate will contribute at a broad and strategic level by developing, implementing, and executing the Biomarker and Companion Diagnostics Operations strategy.
- Accountable for the cost efficiency and timely delivery of biomarker data and quality commitments including ICH/GCP and applicable regulations.
- Responsible for developing and executing biomarker and companion diagnostics (CDx) operations plan for clinical studies including scenario planning, assessment of feasibility, forecasting of timelines and resource requirements.
- Provides program and indication-specific biomarker operational expertise, innovative and flexible operational solutions and options to guide decision making, bridges both science and operations through cross functional partnerships.
- Provides strategic context and biomarker operational leadership across all clinical studies and relating companion diagnostics activities when appropriate.
- Guides scenario planning, forecasting and cost/benefit analysis of different operational plans.
- Responsible for biomarker operations program-level decision making, risk identification and mitigation strategies. Ensure escalation of issues and risks that significantly affect biomarker program timelines, budget, or quality.
- Provides program specific guidance, clinical biomarker operations expertise, and industry best practices to identify efficiencies.
- Accountable for biomarker operational program goals, milestones, and progress.
- Responsible for the operational implementation of biomarker strategies, including budget tracking and forecasts, project timelines, contract management, and biosample management.
- Monitor status, issues, and proactively communicate progress, challenges or changes that may impact budget, timelines to biomarker leads and project teams.
- Develop training materials and collaborates with clinical development on site trainings for biomarker sample management logistics, sample and testing questions from sites, IRBs, and ethics committees.
- Ensure logistical feasibility for the collection, delivery, and analysis of biosamples under the highest standards of quality, ethics, and informed consent. Work with Research to identify and implement novel and innovative biosample collection and processing techniques.
- Manages relationships with specialty testing vendors to ensure biomarker samples are processed, tested and data are reported to meet development timelines and specifications.
- Contribute to relevant clinical study documents and associated systems (trial blueprint/protocol, Trial Master File, Informed consent, eCRFs, CSRs, etc.); ensuring documentation standards are followed and suitable for inspection.
- Develops organization SOPs and implements best practice documents as appropriate.
- Provides direction and oversight of biomarker outsourcing activities on a program level.
- Support the identification and selection of biomarker vendors in collaboration with the biomarker leads and ClinOps.
- Coordinate and support technical assessment with biomarker vendors, including reviewing of relevant SOP, sample chain of custody.
- Contributes to contract and budget negotiations, execute contracts and statement of work to meet program deliverables.
- Organize and host meetings involving relevant internal or external stakeholders (Clinical Biomarkers, Clinical Ops, Data Management and Vendors as appropriate).
- Life Sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required.
- 7-10+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
- Prior experience with clinical drug development operations, including strategic planning, budget forecasting, timeline and CRO management.
- Clinical or biological laboratory experience with evidence of involvement in the processing and/ or analysis of biological samples.
- Knowledgeable of lab vendors and analytical technologies in the field of neuroscience and autoimmune diseases highly preferable.
- Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH, GCP, GLP highly preferable.
- Strong analytical and problem-solving skills, ability to analyze complex activities and information to arrive at logical conclusions.
- Demonstrated ability to think strategically and develop and execute biomarker/analytical operations strategies in a global setting.
- Some travel may be required.