Director Data Management

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