Director Data Management
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
POSITION SUMMARY:
The Director, Clinical Data Management is responsible for managing, leading, and overseeing all Clinical Data Management planning and operational activities to meet corporate goals, budgets, and timelines. This includes but is not limited to vendor management, budget planning and contract negotiations, driving for development of corporate data standards and standardization, training and oversight for all data management activities, deliverables and timelines from study start-up through study close-out, final reporting, and archiving. The Director will supervise, manage, and lead the design, implementation and ongoing practices of clinical DM processes with internal study resources and/or vendors. Additionally, the Director will be responsible for staffing and resourcing the group appropriately.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Responsible for performance of the function and the development of team members for the assigned program(s)
- Manages programs and makes expert recommendations and/or decisions that assure timelines and deliverables
- Collaborates cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process
- Resolves and/or escalates issues encountered at the department level and improve the performance of the data management function
- Provides the highest level of CRO/vendor oversight to ensure project plans are executed to meet the development needs
- Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders
- Contributes to team building and best practice to achieve the defined data quality with cost efficiency.
- Participates in regulatory audit and/or company initiatives
- Manages direct reports and directs project resource planning and timeline setting
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
- BS/MS in life sciences or related field
- 8 -10 + years of direct data management experience with advanced knowledge in pharmaceutical or CRO industry and strong performance feedback
- Proven supervisory and mentoring skills using a hands-on management approach
- Strong project management skills and experience working with CROs/vendors
- Highly experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance
- Knowledge of GCP, ICH and other regional regulations and compliance
- Experienced with clinical data lifecycle from database set-up and maintenance to database lock
- Detail oriented with excellent writing, verbal, and technical skills
Skills Required
- Bachelor's or master's degree in life sciences or a related field
- 8-10+ years of direct clinical data management experience
- Advanced knowledge of the pharmaceutical or CRO industry
- Proven supervisory and mentoring skills using a hands-on management approach
- Strong project management skills
- Experience working with CROs and vendors
- Advanced experience with CDISC standards and SDTM requirements
- Knowledge of CFR Part 11 compliance
- Knowledge of GCP, ICH, and other regional regulations and compliance requirements
- Experience managing the clinical data lifecycle from database setup and maintenance through database lock
- Excellent writing, verbal, and technical communication skills
What We Do
Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). Azenosertib is being evaluated as a monotherapy and in combination across multiple tumor types in clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. The Company is also leveraging its extensive experience and capabilities to translate its science to advance research on additional areas of opportunity for azenosertib outside PROC.
