Senior Director, Clinical Data Management

Exelixis Inc.•Alameda, CA

41d

About The Position

The Senior Director, Clinical Data Management (CDM) is a highly experienced and influential leader with expert knowledge of Clinical Data Management concepts and processes. This position is accountable for the strategic and operational leadership of CDM activities across all clinical studies Phase I to IV, with organizational scope and demand of internal FTEs, FSP resources, as well as fully outsourced studies across geographic regions. The role requires a well-established leader, with a recognized track record of substantial organizational development and leadership, assuring efficient production and quality of all CDM deliverables. This role has independent decision-making authority for decisions that could have significant/long-term impact on the direction and effectiveness of the CDM organization. The Senior Director, CDM is accountable for the management, development, recruitment and training of employees within the departmental scope, including Director level roles, to meet current and future business needs. This position is expected to be capable of representing CDM and Data & Statistical Sciences in a leadership capacity. The role requires strong partnership and close collaboration with senior functional and matrix leaders across the R&D organization to ensure the successful, efficient, high-quality, and compliant delivery for the portfolio area.

Requirements

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.
May require certification in assigned area.
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. Experience developing Director level colleagues is preferred.
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).
Has extensive experience in relevant industry/profession.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Guides the successful completion of major programs, projects and/or functions.
Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
Has complete understanding and wide application of technical principles, theories, concepts and techniques.
Has extensive knowledge of other related disciplines.
Applies strong analytical and business communication skills.
Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines.
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.
Creates formal networks involving coordination among groups.

Nice To Haves

Experience in Oncology clinical trials is preferred.
Experience leading major change initiatives is preferred.
Extensive people leadership experience including talent development and performance management of a Clinical Data Management organization is required. Experience developing Director level colleagues is preferred.

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.

Benefits

comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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