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.
The Senior Director, Clinical Data Management will be responsible for managing, leading, and overseeing all Clinical Data Management (CDM) planning and operational activities to meet corporate objectives and timelines within budgets. The Senior Director of CDM will be responsible for building and leading the CDM function, setting visions for the department including strategies, operations, infrastructure, technology innovation, and talent development. The Senior Director will require leadership and organization skills, and experience with early- to late-stage clinical trials. The Senior Director CDM will collaborate closely with other functional leaders to design the best solution to meet business needs. This position will report to the Vice President, Global Clinical Operations.
To provide clinical data management oversight for all Annexon clinical projects.
- Promote standardization, automation, innovation, process improvement, and technology enhancement in CDM and beyond to increase drug development efficiency
- Establish sound CDM processes including SOPs to ensure highest data quality/integrity and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices
- Lead or direct CDM activities including CRF/eCRF design, validation programming, discrepancy management, and database development and production
- Ensure all CDM documentation are complete, accurate and in an inspection-ready state
- Champion and lead the development and implementation of policies, standards, and process improvement initiatives
- Develop and implement a training curriculum for data management activities and principles as required
- Ensure CROs, suppliers, and internal staff meet the highest quality standards per SOPs
- Provide oversight and guidance, as well as establishing key performance metrics to CROs to ensure highest data quality/integrity and regulatory compliance
- Responsible for vendor and technology (e.g., EDC or IRT) evaluation, qualification, and selection
- Use scientific and drug development knowledge to anticipate and mitigate data management-related challenges during clinical trial execution
- Lead strategic decision-making process involving data management issues for ongoing clinical trials, including Case Report Form (CRF) design, database design, data management plans, edit checks/quality review plans, query resolution processes, data transfers, SAE/AE reconciliation, thesaurus coding processes, and database lock
- Provide leadership and independent judgment in the Identification and implementation of methods, techniques, procedures, and evaluation criteria to support analytical output
- Promote productive collaboration between Biometrics and other functions (e.g., Clinical Biomarker, Clinical Operations, Clinical Development, Regulatory Affairs, QA) and ensure proper alignment around data management deliverables
- Identify and implement solutions to global data management and EDC issues and concerns
- Develop resource plan and budget forecast. Manage budget, timelines, and resource needs for CDM with sound judgment and efficiency
- Provide strong leadership and inspiration to CDM staff. Recruit, develop, and motivate robust talents
- Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
- Bachelor's or Master’s degree in a scientific subject area
- Minimum 15 years of CDM experience in a pharmaceutical/biotech or CRO setting with at least 10 years of line management experience; global/international experience a must
- Sophisticated knowledge of CDM processes, EDC systems, database programming, quality management and technology advancements in the field of data management
- In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines
- Experience participating in regulatory submissions and inspections
- Extensive experience in designing, leading and championing cross-functional projects with internal partners and CROs
- Strong track record of line management and supervisory experience of CDM staff and vendors.
- Outstanding problem-solving abilities and influencing/negotiation skills
- Excellent interpersonal, communication, and leadership skills
- Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
- Ability to identify, author, maintain, and train staff on key data management SOPs and work-practice guidelines
- Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude
- Ability to prioritize workload and meet deadlines, demonstrate effective use of time, and handle multiple priorities simultaneously
- Capable of actively identifying project challenges and risks and proposing appropriate solutions to issues
- Excellent written and verbal communication skills
- Willing to travel if required
- Proven leadership and management skills