Senior Director/Executive Director, Clinical Data Management

• BS/BA and/or MS degree in a science- or health-related field, or an equivalent combination of education and experience.
• 12+ years of clinical data management experience in the pharmaceutical or biotechnology industry (15+ years for Executive Director), including 5+ years leading a CDM function or CDM for a major program.
• Demonstrated leadership of data management through database lock for a pivotal (Phase 3 or registrational) study, and CDM contribution to at least one marketing application (BLA, NDA or MAA).
• Deep knowledge of CDM processes, EDC systems (including Medidata Rave), database build and change control, data validation, external data reconciliation, MedDRA and WHODrug coding, quality management and current CDM technology.
• Strong knowledge of GCP, CDISC standards (including CDASH and SDTM), FDA and ICH guidelines, and CDM best practices.
• Proven sponsor-side oversight of CROs and data vendors, including scope, budget and performance management.
• Demonstrated success building or transforming a sponsor-side CDM operating model in a resource-lean biotechnology organization, including rapid amendments, multi-indication studies and frequent interim data cuts.
• Demonstrated line-management experience, with the ability to lead and inspire CDM employees, consultants and external partners.
• Outstanding problem-solving, influencing, negotiation and communication skills; strong attention to detail; and the ability to manage multiple priorities in a fast-paced, resource-lean environment.

• Experience in immunology or rheumatology, cell therapy, gene therapy or other complex biologics.
• Experience with complex composite and responder endpoints, patient-reported outcomes and external data sources (central laboratory, imaging, cell-product and biomarker data).
• Experience preparing a CDM function for a first BLA and regulatory inspection in a small or mid-sized company.
• Experience supporting global (US and EU) clinical studies.

• Serve as Head of Clinical Data Management and set the vision, strategy and operating model for CDM across all Nkarta clinical studies.
• Establish portfolio-wide clinical data governance covering data ownership, standards, system interoperability and decision rights across internal functions and external partners.
• Build a CDM function that scales from the current Phase 1/2 portfolio to future pivotal studies and BLA readiness, with the right balance of in-house, contract and CRO resources.
• Define and execute a pivotal-readiness roadmap before study initiation, encompassing data standards, system architecture, vendor capabilities, resourcing, quality controls and inspection-ready documentation.
• Align CDM plans, resources and timelines with corporate objectives and study milestones; flag risks early with recommendations.
• Represent CDM on program teams and in leadership forums, and drive cross-functional data strategy with Clinical Development, Biostatistics, Clinical Operations, Regulatory Affairs, Drug Safety, Translational Medicine and Medical Writing so that data are clinically meaningful, traceable and fit for analysis and regulatory use.

• Participate in protocol development and amendment review to ensure that what the protocol requires can be collected, cleaned and analyzed; drive CRF and electronic data capture (EDC) design accordingly.
• Own EDC change control for protocol amendments—specifications, edit checks, user acceptance testing (UAT), migration and release—delivered on time without loss of data integrity.
• Develop and maintain data management plans covering data collection, processing, medical coding, reconciliation (including SAE and central laboratory data), review and storage.
• Own the end-to-end strategy for external data flows, including transfer specifications and agreements, ingestion validation, traceability, reconciliation, exception handling and timely availability of laboratory, imaging, biomarker, safety and cell-product data.
• Plan and deliver clean data snapshots and locked databases, as appropriate, for interim analyses, safety and data monitoring committee reviews, congress presentations, regulatory submissions and study close-out.
• Lead cross-functional data review with Clinical Development, Biostatistics and Drug Safety; direct discrepancy and query management and resolve data issues at their root.
• Establish risk-based data quality oversight that identifies trends in delayed entry, unresolved queries and recurring vendor or site issues; lead root-cause analysis and corrective actions.

• Provide sponsor oversight of the biometrics CRO, data management contractors and other data vendors: define scope, key performance indicators, sponsor acceptance criteria and escalation pathways; review deliverables against specification; and drive remediation of performance issues.
• Lead selection, auditing and onboarding of CDM and Biometrics vendors, including vendor strategy for pivotal and global studies.
• Oversee the quality and integrity of clinical trial data from third-party vendors (e.g., CROs, central and specialty labs, eCOA/ePRO, imaging, IRT), reviewing vendor data for accuracy, completeness and timeliness and resolving discrepancies. Own CDM resource planning, budget forecasting and change-order review.

• Lead the creation and continuous improvement of CDM Global Standard Operating Procedures (GSOPs), work instructions and standards aligned with CDISC (CDASH/SDTM), Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP), 21 CFR Part 11, applicable data privacy requirements and International Council for Harmonisation (ICH) E6 guidelines.
• Maintain complete, current, inspection-ready CDM documentation in the Trial Master File—eCRF specifications and completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, data management plans and change-control logs—with traceable evidence that data management controls operated effectively.
• Prepare the CDM function and its vendors for BLA submission, regulatory inspection and audit; lead CDM responses to audit findings and quality events.

• Recruit, develop and lead CDM employees and consultants; set clear expectations, coach for growth, and create a team culture of accountability and data quality.
• At either level, own portfolio-wide data strategy, governance and pivotal readiness; at Executive Director level, take on broader scope, including portfolio-wide data standards, systems and analytics, ex-US CDM strategy, and greater organizational leadership and enterprise influence.

Priority will be given to candidates who can work a hybrid schedule and based in South San Francisco, CA. Travel may be required for health-authority meetings, conferences, vendor oversight, and other business needs.

There are several factors taken into consideration in determining base salary, including but not limited to: job-related qualifications, skills, education and experience, as well as the value of other elements of an employee’s total compensation package. Nkarta also offers an annual discretionary bonus, equity grant(s), medical, dental, vision and life insurance coverage, in accordance with the terms and conditions of the applicable plans. Other benefits include 401K plan, flexible spending account, ESPP, employee assistance program, paid vacation, holiday and personal days, paid parental, pregnancy, and bereavement leave.

The 100+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas on which we are working, here are real, anonymous comments about or regarding why people think Nkarta is a great place to work.

• “People are always open to ideas.”
• “Exceptionally talented, committed, *kind* & supportive team.”
• “The CEO is transparent and honest with expectations for the whole company. There is genuine care amongst the leadership team for their peers and employees. I believe this is unique.”
• “Not to sound corny, but the emphasis on people as a valuable resource is something I recognize doesn't often exist elsewhere, and it's here in ample supply, which is great.”
• “It's the first place that I've worked where the executive team truly values the employees. It's a pretty amazing thing not to hear that employees can be replaced with someone new. Institutional knowledge is understood.”
• “We have a very diverse team with executives that are friendly and accessible.”
• “Smart and dedicated colleagues. Mission to make a difference in patients’ lives. Empower us with tools needed to succeed. Open and transparent culture. Transparent leadership.”

To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company’s website at https://www.nkartatx.com.

$285,000—$330,000 USD

Nkarta is a publicly traded (Nasdaq symbol NKTX), clinical-stage biotechnology company headquartered in South San Francisco, focused on advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies to treat autoimmune disease.

Founded in 2015, Nkarta is on a mission to harness the body’s natural killer cells – the immune system’s first responders – to deliver a safe, accessible form of cell therapy to treat B cell-mediated autoimmune diseases. Our vision is to make cell therapy more broadly available to patients by pioneering allogeneic NK cells that can be dosed in outpatient, community health settings.

Nkarta’s engineering process enhances the natural ability of NK cells to fight disease by identifying and eliminating unhealthy cells, including malfunctioning B cells at the root of many autoimmune conditions. Our lead NK cell therapy candidate, NKX019, uses NK cells collected from healthy donors rather than burdening the patient with a blood collection. Using donor-derived cells allows us to develop CAR NK cells off the shelf and on demand.

Nkarta is a people-driven company looking for passionate, collaborative, determined team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.