Director of Data Management

Job Description

Job Description

Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. We were founded in 2014 and are headquartered in Boston, Massachusetts. For more information, visit www.compasstherapeutics.com.

Our Clinical team is seeking a hands-on Director of Data Management, reporting onsite to our SVP & Head of Clinical Development. The ideal candidate will have a scientific background and desires to be part of a fast paced and collaborative team, where there is opportunity for career growth.

This position is onsite 4 days / week in our Brighton, MA office.

Responsibilities :

• Lead Data Management activities across all oncology clinical programs, from protocol design to database lock
• Work with CRO database designers to design, build, and test the electronic data capture (EDC) database; design specifications for interactive response technology (IRT) and their integration with EDC; reconcile data between EDC and safety database, perform edit checks and create data review specifications
• Review and analyze clinical data adhering to department and corporate goals and timelines
• Develop and review study plans and protocols to ensure that data collection and case report form (CRF) design meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines)
• Review TLF (Tables, Listings, Figures) development supporting Clinical Study Reports (CSRs), Common Technical Documents (CTDs) for BLA submission, and other documents as needed
• Provide data review and validation support for the analysis of clinical and safety datasets, TLFs, shells and specifications for regulatory reporting to drive clinical decision making
• Serve as the clinical data SME across all clinical programs, responsible for quality and timely deliverables within set timelines in collaboration with internal and external stakeholders
• Manage external queries and review responses from sites, perform external data reconciliation (ECG, Central Imaging, Questionnaires, etc.) and SAE reconciliation
• Facilitate data transfer agreements (DTAs) with external vendors, ensuring data specifications and transfer schedules align with study protocols
• Drive the success of our clinical programs in close collaboration with our Clinical team, and in accordance with ICH / GCP guidelines and other regulatory requirements
• Review imaging result entries in EDC to ensure the evaluation of responses are aligned with the study specific response criteria (RECIST, Lugano)
• Author sections of clinical trial protocols, investigator brochure (IB), publications, Regulatory filings and submissions, and provide support when reviewing clinical documents including study documentation, Trial Master File (TMF), clinical trial design, Clinical Study Reports (CSRs) and data analysis
• Partner with leaders across the organization, present and discuss clinical data findings with cross-functional teams in order to : assess feasibility of endpoints, analyze the resulting data, and appropriately interpret the results to recommend clinical decisions
• Additional responsibilities include ad-hoc projects supporting Clinical initiatives, and Preclinical data management as needed

Qualifications :

At Compass, we provide employees with an inclusive offering of benefits and a competitive compensation package. We offer our employees competitive salaries, discretionary bonuses, and meaningful equity participation. Our innovative benefits support the health and wellness of our employees; from medical, dental and vision benefits to health reimbursement arrangement, flexible spending accounts, sponsored gym membership, an employee assistance program, life insurance, and much more. We also provide 401(k) and Roth 401(k) programs with a 6% company match, and other resources for financial wellness. Additional benefits include commuter reimbursement, subsidized company parking, cell phone reimbursement, Summer Fridays, and substantial paid time off including a winter shut down week.

Our Mission at Compass is to develop next generation antibodies into transformative cancer therapies that improve patients' lives. Our Compass Core Values guide us in achieving this. We are mission-focused and share a passion for science and creativity that help us innovate in all that we do. Our unique community promotes authenticity, diversity of thought, and collaborative teamwork .

We invest in the growth and development of our teams and individuals through programs such as company-wide trainings, cross-functional collaboration and job shadowing, tuition reimbursement, employee recognition awards, and a comprehensive performance management cycle. Also, our Compass Culture Committee empowers employee-organized events that celebrate wins, drive initiatives, support local philanthropy, and align with our mission and values.