Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
Exelixis has newly formed the Digital Transformation (DT) function to effectively support Exelixis’ rapid growth which is expected in the next 3 to 5 years. To support business functions in process simplification, automation and data-driven decision making, DT will introduce relevant technology products. DT products will aid in sustaining both organic and inorganic growth of Exelixis, increasing operational complexity of additional product launches, indications, capabilities, and geographies. Director, DevIA will focus on product design, development and maturity in close collaboration with business partners from Drug Safety function in simplifying the business processes, enhance digital dexterity of the functions, establish what success looks like for the users of Drug Development organization.
Leads the product design, develop, deploy along with resource and portfolio management to allow these respective functions to scale, and enhance the maturity of the Drug Development capabilities, and optimize human resource levels and allocation.
Collaborates with key stakeholders to determine scope and nature of business requirements and priorities to consider in support of the Drug Development functions here at Exelixis (primarily focused on Drug Safety, Regulatory). Collaborates with functional and x-functional leaders to establish the vision and define strategies for meeting determined requirements and stays accountable for driving the product maturity roadmaps. Actively involved in identification, evaluation, selection, implementation, ongoing administration and improvement of engineering products, platforms, procedures, and Quality culture to execute the defined vision and product roadmap.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Cultivates and demonstrates an in-depth knowledge of Drug Development business capabilities focused on Drug Safety.
- Participates in short- and long-term strategic planning session to improve business processes through capability development
- Demonstrates how capability enablement can assist departments/business areas and how platforms and solutions can support the achievement of short- and long-term business goals
- Establishes and maintains a strategic relationship with functional level stakeholders
- Development of business value metrics, ROI model in support of investment projects and activities
- Works with functional stakeholders and enable technology to meet business objectives
- Ensures capability expectations are set and identifies and resolves disconnects through negotiation or governance mechanisms
- Analyzes technology trends to determine impact to the capability and benefit realization
- Translate business requirement to functional requirements and implement appropriate solutions leveraging Agile methodologies. Manages and prioritizes the flow of work in program backlog
- Participates in business customer idea workshops and technical problem-solving with potential technical options including proposals, front-end studies, development plans, and presentations, as directed in a consulting role
- Accountable for working with Process Owners, QA to identify validation strategies based on applicable regulatory requirements.
- Leads with scoping, identification of project deliverables, project time estimations, resource level estimations and the creation of project-specific documentation such as technical specifications.
- Defines technical strategies by performing evaluations, proof of concepts and assessments on the various technical aspects of the proposed project solution
- Partners with Scrum masters to develop the technical delivery work plan and schedule and ensures that appropriate technical delivery staffing resources are assigned, and effectively utilized.
- Ensures formal technical and technical performance reviews are conducted and provides feedback and suggestions
- Ensures that training design documentation and delivery from a technical perspective are in place
- Keeps abreast of industry trends and advancements in relevant technology
- Ability to analyze complex business problems and evaluate solutions. Ability to translate complex technical issues into business terms. Excellent analytical, problem-solving, and troubleshooting skills
- Provide direction to other individuals.
- Supervises, hires, trains, provides work direction, and problem-solving assistance for student
- Supervises staff, including hiring, scheduling and assigning work, reviewing performance, and
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
- Bachelors degree in related discipline + 14 years of related experience; or
- Masters degree in related discipline and 12 years of related experience; or
- PhD degree in related discipline and 10 years of related experience; or
- Equivalent combination of education and experience.
- Experience is required in the areas of technology strategy, product design, engineering, platforms, data architecture, and analytics.
- Experience in Biotech/Pharma with emphasis on Drug Development area.
- Experience with Agile, Scrum methodologies and DevOps. Cloud certifications and AWS experience is highly desired.
- Experience working on various Pharmaceutical Clinical Development systems like Argus, RIM, Content Management, AWS, Reporting and Analytics (Tableau, Sisense, Spotfire)
- Experience working with Computer System Validation in a GxP regulated area
- Strong Delivery skills, ability to work in a complex environment and an ability to influence cross-functional teams
- Experience working with SaaS applications and monitoring service levels and deployment schedules
- Experience managing a large group of consultants for delivery and sustainment and ensuring the quality of deliverables
- Bridges gap between business and IT
- Strong Listener: Be able to patiently listen to understand the business needs
- Bachelor’s degree in IT, CS, Business Process Management or related discipline or an equivalent number of years of work experience
- Comprehensive Knowledge of Clinical Drug Development processes, tools and industry benchmarking data.
- Thorough knowledge of all aspects of Drug Safety, Regulatory and Clinical Operations suite of products namely ranging from Argus, Regulatory Information Management, CTMS, eTMF, EDC etc.
- Demonstrated ability to participate with business in launching technologies to support drug launches, deliver large, complex, programs involving system and process reengineering and integration.
- Proven ability to collaborate with senior functional leaders to set vision, drive innovation and facilitate transformation to meet evolving business needs and priorities.
- Applies strong analytical and business communication skills.
- Environment: primarily working indoors of buildings
- Physical effort/lifting, such as sedentary - up to 10 pounds
- Travel not typically required
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.