Exel
Clinical Data Management Director
Alameda, CA · Director
Sponsorship not specified$182k-$258kDetected 31 days ago
GCPData ScienceClinical TrialsClinical ResearchResearchLeadershipCommunication
About the role
- This position is accountable for the operational leadership of CDM activities across all solid tumor oncology clinical studies Phase I to IV, with organizational scope in various resourcing models across geographic regions.
- These positions serve as the eyes and ears of CDM/DSB, provide leadership in data completeness and quality, key contributors to the data collection and quality strategy, and provide cross-functional leadership in these areas.
Responsibilities
- Excellent organizational ability to manage CDM workload and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement/utilization.
- Provide a leadership role in department process development and optimization of related clinical research activities. Lead or support the initiatives to drive change within CDM/BSD as well as across PDMA from a clinical data perspective.
- Align processes and priorities across the portfolio to maximize organizational effectiveness; design and implement innovative approaches to enhance productivity and effectiveness.
- Strong customer focus and belief in Exelixis values; creates a positive value-based work environment for the CDM department.
- Align with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence the strategy and direction of CDM.
Requirements
- The Clinical Data Management (CDM) Director is a highly experienced and influential leader with expert knowledge of Clinical Data Management concepts and processes.
- BS/BA degree in related discipline and a minimum of 13 years of related experience
- MS/MA degree in related discipline and a minimum of 11 years of related experience
- PhD in related discipline and a minimum of 8 years of related experience, or;
- SUMMARY/JOB PURPOSE: The Clinical Data Management (CDM) Director is a highly experienced and influential leader with expert knowledge of Clinical Data Management concepts and processes.
Nice to have
- Experience in Biotech/Pharmaceutical industry required.
- Experience in Oncology clinical trials is preferred.
- Experience leading change initiatives is preferred.
- Demonstrated experience leading global data management activities is required.
- Experience participating in regulatory submissions and inspections is required.
- A minimum of 8 years of leading teams in a highly matrixed organization.
- Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC) and policies relevant to Data Management and risk based data management approach of clinical data (e.g., GCP, ICH).
Skills
- Has extensive experience in relevant industry/profession.
- Guides the successful completion of major programs, projects and/or functions.
- Has complete understanding and wide application of technical principles, theories, concepts and techniques.
- Has strong knowledge of other related disciplines.
- Applies strong analytical and business communication skills.
- Knowledge of Good Clinical Practices (GCP) is essential.
- Demonstrated success managing data management activities of Clinical Research Organizations (CROs).
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
- Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
- Education/Experience:
- BS/BA degree in related discipline and a minimum of 13 years of related experience; or,
- MS/MA degree in related discipline and a minimum of 11 years of related experience; or,
Compensation
- Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.
Benefits
- Interacts with Produce Development & Medical Affairs colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality CDM/DSB deliverables.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.