Clinical Director Jobs

About The Position

Requirements

• At least 15 years of relevant industry experience in clinical data management or closely related clinical data functions.
• Substantial experience managing staff in a global setting, including leading managers.
• Oncology clinical trial experience, including late-phase or registrational studies.
• Demonstrated experience leading or sponsoring CDM modernization with measurable results, such as automation, risk-based data review, advanced analytics, or AI/ML-enabled capabilities.
• Experience supporting health authority inspections and regulatory submissions.
• Bachelor’s degree in life sciences, health informatics, data science, computer science, or a related discipline.
• Expert understanding of drug development, clinical trial execution, data, and systems.
• Expert knowledge of GCP/ICH guidelines, including ICH E6(R3), and data standards.
• Substantial experience leading a function and sizeable global team, resolving complex issues, and driving significant initiatives to completion.
• Ability to lead and make decisions with an enterprise mindset, considering what is best for the company and patients.
• Technical expertise to serve as a credible interface to global development and business partners.
• Broad understanding of the clinical trial environment across key regions and ability to anticipate future trends and impacts.
• Strong influential leadership and communication capabilities, including engaging, managing, developing, and inspiring a geographically diverse team.
• Demonstrated partnership across collaborative and industry forums.
• Expert knowledge of industry trends and emerging technologies for clinical trial data acquisition and management, including AI/ML, generative AI, automation, RBQM, and modern cloud data platforms.
• Practical understanding of the capabilities and limitations of ML and LLM-based tools, and ability to evaluate claims about training data, validation, bias, explainability, and performance.
• Working knowledge of regulatory expectations for AI in drug development, including the FDA risk-based credibility framework and FDA/EMA good AI practice principles, and ability to apply them to CDM use cases.
• Use of metrics, analytics, and data visualization to guide operations and demonstrate value.
• Proven change leadership, including introducing technologies and new ways of working, reskilling teams, and sustaining adoption.
• Familiarity with clinical data platforms and ecosystems, including EDC, eCOA, IRT, and data integration and review tools, sufficient to set architecture and vendor direction.

Nice To Haves

• Advanced degree, such as an MS, PharmD, PhD, or MBA.
• Professional certification such as CCDM or PMP, or formal training in data science/AI.
• Experience deploying GxP-validated AI/ML or generative AI solutions.
• Experience with novel oncology modalities such as cell therapy, ADCs, or radiopharmaceuticals.
• CRO/FSP governance at scale.

Responsibilities

• Define the strategic vision, multi-year roadmap, and operating model for the oncology CDM organization.
• Provide CDM leadership for oncology programs and tumor types, including oversight and governance of data deliverables for high-value and registrational clinical trials.
• Shape data acquisition strategies for evolving oncology trial designs and data types, including adaptive and master-protocol studies, tumor response and imaging, biomarker and genomic data, patient-reported outcomes, and real-world data.
• Build partnerships across Clinical Development, Biostatistics and Programming, Clinical Operations, Biomarkers, Regulatory, Quality, and Digital/IT.
• Support and execute the CDM AI and automation strategy; identify and prioritize high-value use cases.
• Lead the shift to continuous, risk-based, near-real-time data review and surveillance in partnership with Clinical Operations and Biostatistics.
• Ensure responsible and compliant use of AI, including generative AI and large language models, with attention to privacy, confidentiality, integrity, and explainability.
• Drive adoption and measurable value by redesigning processes and roles, leading change management, and tracking cycle time, query volume, data quality, cost, and site burden.
• Oversee and govern CDM deliverables throughout the study lifecycle across EDC and other clinical data sources, including eCOA/ePRO, imaging, central lab, and biomarker data.
• Deliver functional performance metrics and KPIs, such as start-up and database-lock timelines, query aging, data quality, and completeness, and report performance to senior leadership.
• Resolve complex cross-study issues and drive significant initiatives to completion.
• Ensure efficient, effective, and compliant working practices aligned with GCP, ICH E6(R3), 21 CFR Part 11, EU Annex 11, data privacy regulations, and computerized system validation requirements.
• Maintain inspection readiness for CDM processes, systems, and documentation; represent CDM in health authority inspections and audits and ensure effective CAPA.
• Ensure adherence to data standards such as CDISC and delivery of submission-ready data for regulatory filings.
• Set sourcing strategy and govern CRO, FSP, and technology data vendors, including selection, oversight, KPIs, and escalation.
• Support departmental budgets, resource forecasting, and capacity planning for the oncology CDM portfolio.
• Lead and develop a global CDM team through feedback, coaching, career development, engagement and retention efforts, and performance accountability.
• Build team capabilities in data and AI literacy, analytical skills, and use of AI-enabled tools.
• Communicate goals, priorities, and business-critical information to employees and promote a culture of diversity of thought, integrity, coaching, and accountability.
• Represent the company with external organizations, committees, and industry groups relating to clinical data acquisition and management, including emerging technology and AI practices.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to eligibility and plan terms.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• 11 paid company holidays each year.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Additional discretionary incentive cash and stock opportunities may be available.