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Exelixis · 2 weeks ago

Senior Director, Clinical Data Management

Alameda, CA

Full-time

Onsite

Director/Executive

$226K/yr - $321K/yr

17+ years exp

Exelixis is a company focused on clinical data management, seeking a Senior Director to lead CDM activities across all clinical studies from Phase I to IV. The role involves strategic leadership, management of clinical data teams, and collaboration with senior functional leaders to ensure high-quality deliverables.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Key member of the CDM Senior Leadership Team with accountability for assigned clinical programs with a combination of FTEs, Functional Sourcing Provider (FSP) or fully outsourced resources with a combination of on-shore and off-shore resources

Responsible for functional Clinical Data Management leadership with high material impact for company in a strong competitive landscape. Needs to navigate challenging and complex organizational structure of a growing company

Strategic leadership accountabilities include driving the development of capabilities and shaping organizational structures across a growing and complex functional portfolio

Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees, including Director level individuals across the function

Represents department in cross-functional discussions and step-in for Head of CDM as needed. Lead discussions with senior R&D colleagues to strengthen coordination between cross-functional and cross-sector departments. This position has direct interface with senior stakeholders and influencers across R&D including TA, Functional Leaders, and partnering functions including Information Technology, Strategic Sourcing & Procurement and others

Aligns with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence the strategy and direction of CDM. Interacts with R&D colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality CDM deliverables

Excellent organizational ability to manage CDM workload (incl across TAs) and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement/utilization with potential to impact and drive vendor capacity due to span of portfolio demand

Leader in continuous development and adjustment of innovative operating models. Able to lead, inspire and influence team/organization through rapidly changing business challenges

Provides a leadership role in department process development and optimization of related clinical research activities. Sponsors/leads initiatives with impact to drive change within and across functions and sectors

Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities

Works with Head of CDM to ensure the department strategy and processes are clear towards all stakeholders with optimal communication and engagement. Align processes and priorities to maximize organizational effectiveness; designs and implements innovative approaches to enhance productivity and effectiveness

Externally leads and sought-after for insights and functional expertise from across industry; able to represent Exelixis in data management, data strategy and other related capacities. Helps establish and maintain Exelixis CDM as an industry leader

Contributes to development and analysis of performance metrics and identifies ways to raise department standards. Responsible for team adherence to standards and compliance

Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. This position is responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables

Strong customer focus and belief in Exelixis values; creates a positive value-based work environment for the CDM department

Qualification

Clinical Data ManagementBiotech/Pharmaceutical experienceOncology clinical trialsLeadership experienceRegulatory submissions experienceGCP knowledgeData management SOPsAnalytical skillsBusiness communicationTalent development

Required

BS/BA degree in related discipline and a minimum of 15 years of related experience; or

MS/MA degree in related discipline and a minimum of 13 years of related experience; or

PhD degree in related discipline and a minimum of 12 years of related experience; or

Equivalent combination of education and experience

Typically requires a minimum of 17 years of related experience and/or combination of experience and education/training

Experience in Biotech/Pharmaceutical industry required

Demonstrated experience leading global data management teams is required

Experience participating in regulatory submissions and inspections is required

A minimum of 10 years of line management experience is required

Extensive people leadership experience including talent development and performance management of a Clinical Data Management organization is required

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)

Knowledge of Good Clinical Practices (GCP) is essential