Director, Clinical Data Manager (SSF, CA or Remote)
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
The Director, Clinical Data Manager (CDM) will work collaboratively in a fast-paced, cross-functional team environment. We are seeking a highly motivated individual to join our dynamic Biometrics department. This individual will plan a key role in building and leading the CDM function, assisting in the development of strategies, operations, infrastructure and technical innovation. Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals. This position will report to the Senior Director CDM.
- Provide a high level of expertise in data management to support clinical studies.
- Promote standardization, automation, process improvement and technical enhancement in CDM to improve efficiency
- Lead or direct the design of CRFs/eCRF for sound and thorough data collection through the regulatory approval process and support of CDASH/CDISC guidelines.
- Able to review and provide feedback on DM documents (e.g., DMP, edit check specifications, vendor specifications, upgrades/migrations, user acceptance testing) and other study documents, such as Statistical Analysis Plans.
- Ensure that documentation, data quality and integrity are maintained throughout the study.
- Review study protocols and assist in the planning and implementation of the data management portions.
- Lead in the establishment of CDM processes, including identifying, authoring SOPs and Work Instructions to ensure regulatory compliance, GCP, and ICH.
- Lead in study reviews to ensure inspection-readiness of DM documentation, processes and development of study storyboards.
- Lead or assist in the evaluation, qualification, and selection of vendors and technology (e.g., EDC).
- Provide strong leadership and good judgment in the implementation of methods, techniques, procedures to support analytical output.
- Identify and implement solutions to data management and handle Electronic Data Capture (EDC) issues and concerns.
- Assist in budget forecast and management of budgets, timelines and resources.
- Provide leadership in training and direction to new or junior staff in clinical data management.
- Serves as an active member of Clinical Study Teams (CST).
- Works with other functions to promote collaborative deliverables in the develop timelines and ensure proper alignment around DM deliverables.
- Provides DM CRO and Vendor Oversight, as applicable.
- Ensure data cleaning and data reconciliations (e.g., labs, SAE recon) are addressed to meet milestones
- Proven leadership and management skills
- Other duties as assigned.
- Bachelor’s or Masters’ degree in a scientific subject area
- Minimum 11 years of clinical data management experience in biotechnology or pharmaceutical industry
- Minimum 8 years of Electronic Data Capture (EDC) experience; IXRS development preferred
- Proficient computer skills, including Microsoft Office applications
- Must have strong knowledge of Data Management processes and systems
- Solid understanding of clinical drug development processes required
- Must have demonstrated problem solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment
- Excellent written and verbal communication skills are required
- Experience and understanding of ICH, GCP, and CDASH/CDISC are required
- Experience participating in regulatory submissions and inspections are required
- Experience with Medidata Rave required
- Experience in MedDRA and WHODrug coding
- Agency filing experience a plus
- Willing to travel on occasion
- Residence in the bay area preferred
- Annexon’s Director Clinical Data Manager 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.