Director, Data Management (Remote optional)

General Summary of Duties:

This position plays a key role in development of data management strategies including outsourcing and oversight strategies, standards and processes. Serves as the subject matter expert related to data management activities across multiple assets. Provides and manages all data management deliverables for the clinical projects. Working closely with other members of the team across related functional areas such as Clinical Development, Safety, Clinical Operations, Translational, Bioinformatics, Biostatistics, Statistical Programming, Medical Writing.

Reports to VP Translational Genomics, or designee.

Specific Duties, may include but not be limited to the following:

• Lead Data Management function, providing strategic planning and tactical direction across all studies
• Conduct vendor qualifications and manage relationships with CROs and data management vendors to ensure timely, high-quality deliverables
• Oversee data management activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database releases
• Establishes and maintains procedures for gathering, analyzing and reporting clinical data
• Accountable for organizing and managing internal data review processes, and collaborates with other stakeholders such as Clinical Development, Translational, Safety, Clinical Operations, Biostatistics, Statistical Programming, Medical Writing.
• Ensures data preparedness for key project deliverables, including regulatory meetings, scientific meetings and publications
• Develop and implement data management plans (DMPs) to ensure regulatory compliance and standardization across studies
• Ensures adherence to regulatory guidelines (e.g. ICH, GCP)
• Collaborate with other functional heads on data driven strategies and keep the team informed on issues with business impact
• Set priorities and ensure consistency across programs within oncology portfolio
• Keep abreast of key developments in data management and statistics, clinical development, regulatory requirements and guidance, and industry standards for data collection, e.g. CDASH, SDTM, and ADaM.
• Author data management SOPs and contribute to review of all other departmental SOPs and provide training on data management topics

Desired Skills and Qualifications

• B.S. (or higher) degree in a Science or related field
• Minimum of 10 years’ total experience in drug development environments, including hands on data management roles as well as leading appropriate function/department
• Prior experience working within a fast-paced biotech environment is highly desired
• Must be able to be resourceful and budget conscious within the individual contributor role and work collaboratively within teams to achieve outcomes
• Experience in Oncology trials (including early phase) and global trials is a plus
• Detail oriented with a thorough knowledge of clinical and data management operations
• Thorough knowledge of using data management technologies and CDISC data standards
• Excellent interpersonal, leadership, and communication skills
• Strong collaborative skills and ability to work with a cross‐functional team
• Strong project management skills
• Proven ability to develop and maintain successful working relationships with internal and external stakeholders
• Strong analytical and organization skills
• Self-motivated and self-directed with a strong work ethic and ability to model the Immuneering Values: Humble, Data Rules, Care, All in and Own it.
• Excellent people and communication skills for use in influencing, motivating, mentoring, and encouraging team members to understand/accept recommendations

Physical Demands/ Working Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This role can be remote. Extensive travel is not anticipated with this role. Requires prolonged sitting, some bending, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Work is performed in a remote office environment and involves minimal to no contact with staff and the public.

The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.

Immuneering provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.