Director, eClinical Solutions

Exelixi; Alameda (CA); Vor Ort; USD 224.000 - 284.000; Vollzeit

Benefits dieser Stelle

401(k) match with company contribution

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Zusammenfassung

Exelixis in Alameda, CA, seeks a senior leader to oversee clinical and operational data systems across Phase I–IV trials. You will drive EDC governance, select vendors, and transform data capture technologies to improve trial efficiency.

The role requires extensive Biotech/pharma experience, strong GCP/ICH knowledge, and a track record in guiding regulatory submissions and large-scale data programs.

Qualifikationen

• Minimum of 13 years of related experience for BS/BA path; 11 years for MS/MA; 8 years for PhD.
• Experience in Biotech/Pharmaceutical industry is required.
• Experience in Oncology clinical trials is preferred.
• Experience leading major change initiatives is required.
• Experience participating in regulatory submissions and inspections is required.

Aufgaben

• Oversee, develops and manages clinical and operational data systems and infrastructure projects.
• Provide governance and oversight of EDC vendors and service providers.
• Lead continuous process improvement in data management and data standards.
• Develop training curricula for data management activities and SOPs.
• Direct supervision of employees with accountability for performance and staffing.

Kenntnisse

Clinical data management

Biotech/pharma experience

Oncology trials

GCP/ICH knowledge

EDC systems

Leadership/people management

Regulatory submissions

Ausbildung

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Certifications in data management

Tools

EDC platforms

CDISC standards

Jobbeschreibung

SUMMARY/JOB PURPOSE (Basic purpose of the job):Oversees, develops and manages clinical and operational data systems and infrastructure-related projects while collaborating and coordinating with all other functions across Data & Statistical Sciences (DSS), Clinical Operations, IT, and other stakeholders/departments. Oversees the evaluation and implementation of data capture systems (e.g., Electronic Data Capture (EDC)) in support of clinical trial execution, along with necessary integrations with other systems.Key member of the Clinical Data Management department with accountability for technology solutions and processes to support all clinical trials Phase I to IV with a combination of employees or Functional Service Provider (FSP) staff.ESSENTIAL DUTIES/RESPONSIBILITIES:Works closely with the broader Clinical Data Management team to understand strategy and business needs as well as industry trends and evolving EDC technology in the marketplace.Provide Business Ownership of EDC systems, evaluate and select EDC vendors and associated service providers. Establish governance and oversight and governance of these vendors.Evaluate the optimal use of data capture technologies to ensure efficient and effective clinical trial execution. Partner with stakeholders to develop strategies that transform the use of technologies in Clinical Data Management that enhance the deployment of human resources to optimally productive and value-added tasks vs tasks that would be better automated through the use of AI, ML, etc.Support the development and governance of Data Standards as well as the creation of standard eCRFs to streamline processes.Foster a leadership culture which attracts, develops and retains high caliber individuals with expertise in clinical technology capable of and committed to providing valuable and creative input to Exelixis projects to achieve or exceed company goals. Ensure accountable performance management of all staff against personal management plans and expected behavior.Lead Continuous Process Improvement initiatives to implement clinical and operational data strategies.Manage time and resource constraints across multiple projects.Contribute to the development and implementation of new or improved processes for Clinical Data Management.Provide oversight on quality and timeliness of task completion by direct reports.Develop and implement training curriculum for data management activities and principles as required.SUPERVISORY RESPONSIBILITIES:Directly supervises employees.May indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:Education: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,PhD in related discipline and a minimum of 8 years of related experience; or,Equivalent combination of education and experience.May require certification in assigned area.Experience:Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.Experience in Biotech/Pharmaceutical industry required.Experience in Oncology clinical trials is preferred.Experience leading major change initiatives is required.Experience participating in regulatory submissions and inspections is required.A minimum of 8 years of line management experience is preferred.Extensive people leadership experience including talent development and performance management.Excellent understanding of clinical development, quality and regulatory standards (eg., CDISC) and policies relevant to Clinical Data Management and risk-based data management approach of clinical data (e.g., GCP, ICH).Knowledge, Skills and Abilities: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.Environment: primarily working indoors.#LI-JP1Location: Alameda, CA Range for this position: $224,000 - $284,000 The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers 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.If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail] CONDITIONS:Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.DISCLAIMER:The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.