Senior Director, Clinical Data Management
Who We Are
Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us
Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values
- Character: Committed to always doing what’s right.
- Audacity: Willing to challenge convention and share candid feedback with others.
- Determination: Curious and self-motivated. Always looking to improve and learn.
- Collaboration: "No job is too small" mentality. Humble and willing to help others.
- Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.
The “Fine Print” – What You’ll Do
- Owns and drives the success of CDM across all programs.
- Leads and mentors CDM team members and contractors.
- Direct the design and implementation of the CDM process with vendors.
- Collaborate with clinical development team to develop short-term and long-term strategies to improve data management quality and efficiency.
- Oversee development of standardized eCRFs
- Review and approve Data Management Plans, Data Transfer Agreements, Edit Check Specifications, and any changes to EDC In collaboration with cross-functional departments.
- Oversee activities to lock clinical databases. Develop timelines/milestones for data cleaning, identify data review tasks, and assign and coordinate data review activities.
- Lead the development and maintenance of Standard Operating Procedures (SOPs) and Work instructions related to CDM activities.
- Work with Head of Biometrics to plan CDM budget and assess resource needs.
Skills and Experience We Look For
- BA/BS in scientific or health-related field.
- 13+ years of clinical data management experience in a regulatory environment in the pharmaceutical or biotechnology industry.
- Oncology trial experience required, hematology/oncology/autoimmune highly preferred.
- 3+ years of experience with proven ability of successfully overseeing multiple clinical trials.
- Experience successfully leading a CDM group.
- Extensive background collaborating with CROs, vendors, and internal study teams.
- In-depth knowledge and experience with different clinical systems.
- Possesses a comprehensive understanding of regulatory guidelines and industry standards and their application to DM practice.
- Strong experience in demonstrating appropriate balance of business and technical capabilities.
- Capable of actively identifying project challenges and risks, and proposing appropriate and strategic solutions to issue.
Rewards at Arcellx
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
The estimated base salary range for this position is $265,000 - $295,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to www.arcellx.com.
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