Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
The Director, Data Systems (DS) and Clinical Programming (CP) will be responsible for leading and managing the Clinical Programming function within Data Management (DM). This position will report to the VP, Data Management and Clinical Programming.
Responsibilities:
- Lead and manage the Data Systems and Clinical Programming function within DM
- Drive the implementation of various technology solutions to augment existing DM processes, optimize efficiency and enhance overall data quality assurance
- Lead and/or participate in AI-related initiatives for DM
- Develop and implement strategies for optimizing data flow, database builds, and integration of external technologies.
- Oversee the validation of the EDC platform, ensuring ongoing system optimization.
- Manage relationships with key external vendors, ensuring alignment with organizational goals.
- Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data.
- Ensure DS&CP project deliverables are completed on time and in accordance with quality standards and regulatory requirements.
- Collaborate with other departments to align data strategy with broader organizational goals and objectives.
- Mentor and develop team members, fostering a culture of continuous learning and growth within the team.
- Oversee all SAS clinical programming requests and standardize the clinical programming specification development process.
- Develop and/or maintain Alumis’ standard CRFs and standard edit checks, inclusive of indication-specific standards.
- Develop DS&CP SOPs and Work Instructions.
- Lead the development and/or maintenance of standard vendor Data Transfer Agreements (DTAs).
- Oversee the development and execution of technical initiatives within DM, including the implementation of key data visualizations and dashboards for DM, such as Clean Patient Tracking, data currency, and rolling batch freeze progress.
- Integrate the usage of data analytics within DM to further optimize current processes.
- Provide strategic oversight of high-priority projects, including database builds, user access management, and the release of system updates.
- Participate in EDC, IRT and eCOA User Acceptance Testing (UAT)
- Ensure accurate development and execution of data integrations between EDC, IXRS or additional external vendor data sources
- Ensure DS&CP study-specific documentation is in an inspection-ready state and represent the DS&CP function in inspections as applicable.
- Represent DS&CP in cross-functional meetings as applicable
- Act as a key stakeholder in developing and executing strategies to accelerate drug development through innovative data management practices.
Qualifications:
- 12+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus
- Experience supporting Ph I-IV clinical trials, both in-house and through CRO partners
- Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)
- Proficiency in CDISC standards (CDASH, SDTM, ADaM)
- Experience with SAS, SQL and/or other clinical programming tools
- Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
- Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, vendor management, DM study documentation and inspection readiness.
- Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems
- Strong interpersonal, organizational, and communication (oral and written) skills
- Demonstrated ability to cultivate strong working relationships with internal and external colleagues.
- Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities
- Ability to prioritize and to adapt quickly to changing business conditions with a “can-do” attitude
- Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.
- Willing to travel if required
Alumis Values
• We Elevate
• We Challenge
• We Nurture
This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Open to remote applicants with requirement to be onsite 1-2x a quarter.
The salary range for this position is $200,000 USD to $225,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
Alumis Inc. is an equal opportunity employer.