Senior Director, Clinical Data Standards, Quality & Reporting

SUMMARY/JOB PURPOSE (Basic purpose of the job):

The Senior Director of Clinical Data Standards, Quality and Reporting (CDSQ&R) is a highly experienced and influential leader with expert knowledge of clinical data standards, strategy, acquisition, and reporting concepts and processes. This position is accountable for the operational leadership of strategic clinical data reporting across operational departments to support business needs. This position provides strategic and executional support from the Digital Strategy, Analytics, and Programming (DSA&P) organization to achieve complete, high-quality operational reporting and metrics across departments. It serves as the eyes and ears of DSA&P, provides leadership in clinical data standards, strategy, and reporting, is a key contributor to the data collection and quality strategy, and provides cross-functional leadership in these areas.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Key member of the DSA&P Team with accountability for the leadership of clinical data strategy and operational reporting across departments to support business needs.
• Align with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence operational clinical data reporting strategy and direction. Interact with Product Development & Medical Affairs colleagues, therapeutic or functional area leaders to execute the organizational priorities, focusing on quality DSB deliverables.
• Clinical Data Strategy Execution: Be a change advocate by stewarding and pioneering activities that focus on automation, simplifying processes and system design, and seeking methods to ensure strong interoperability amongst the larger clinical ecosystem.
• Clinical Data Strategy Execution: Demonstrated excellence in forging and maintaining collaborative, positive, and long-lasting partnerships with system stakeholders: functional leaders, end-system user communities, IT and external partners.
• Clinical Data Strategy Execution: High organizational awareness and knowledge of change management to help teams anticipate, plan and adapt to an evolving environment.
• Clinical Data Strategy Execution: Support alignment of processes and priorities across the portfolio to maximize operational effectiveness; design and implement innovative approaches to enhance productivity and effectiveness. Work with leadership to ensure the department strategy and processes are clear to all stakeholders with optimal communication and engagement.
• Clinical Data Strategy Execution: Provide leadership in department process development and optimization of related clinical research activities. Lead or support the initiatives to drive change within DSB and across PDMA from a clinical data perspective.
• Clinical Data Reporting: Provide leadership in developing clinical data reporting across departments and identify ways to raise reporting standards at the study and department levels.
• Clinical Data Reporting: Able to develop solutions to a wide range of complex problems, which require regular ingenuity and innovation.
• Decision-making directly impacts the operational direction and effectiveness of clinical data and the portfolio level due to the scope and span of the area of responsibility.
• Strong customer focus and belief in Exelixis values; creates a positive value-based work environment for the CDM department.

SUPERVISORY RESPONSIBILITIES:

• Lead colleagues in a highly matrixed organization.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in related discipline and a minimum of 15 years of related experience; or,
• MS/MA degree in a related discipline and a minimum of 13 years of related experience; or,
• PhD in related discipline and a minimum of 12 years of related experience; or,
• Equivalent combination of education and experience.

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 preferred.
• Demonstrated experience leading global data management activities is required.
• Experience participating in regulatory submissions and inspections is required.
• A minimum of 10 years of managing 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).

Knowledge, Skills and Abilities:

• Knowledge in current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IRT).
• Competence in programming, such as SAS, Python, PowerBI, Business Object, Tableau for data visualization is a plus.
• 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.
• 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.

Work Environment/Physical Demands:

• This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
• The ADA places responsibility for identifying and documenting each job's essential functions solely on the employer. If challenged by an employee, by the government, or by other third parties, an employer must be able to show the classification of the essential duties of the job.
• Place a mark in the box that closely reflects the critical nature of each applicable items on the Work Environment/Physical Demands Form. This form is optional and for regular office jobs, you can include the following statement below.

Our office is a modern, open-plan space that foster collaborations 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.

Travel requirements can be listed by stating up to certain % of time traveling.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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.