Careers in MedTech

Job Title

Director, Development Informatics and Analytics (Regulatory, Med Affairs )

Company

Exelixis

Description

Biotechnology, pharmaceutical industry experience Director opportunity accountable for planning and implementing business-enabling technology platform solutions within Drug Development functions here at Exelixis (primarily focused on Regulatory Affairs, Medical Affairs & PMO).

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. The Director is a hands-on role accountable for planning and implementing business-enabling technology platform solutions by simplifying the business processes, enhance digital dexterity of the functions, including analytics, that support Development specific capabilities and needs. Maintains expertise and can identify opportunities and associated plans to advance business capabilities. Effective partnership and teamwork with business partners, DT/ IT teams is a key success factor.

The Director, Development Informatics and Analytics will actively collaborate with key stakeholders to understand business requirements and priorities in support of the Drug Development functions here at Exelixis (primarily focused on Regulatory Affairs, Medical Affairs & PMO). This individual will also collaborate with functional and x-functional leaders to establish the vision and drive the implementation of the technology strategies for meeting determined requirements and stays accountable for driving the technology roadmaps. The ideal candidate will be actively involved in identification, evaluation, implementation, and value realization of business capabilities through Agile methods.

The ideal candidate will be an experienced technology professional with in-depth understanding of Drug Development business domains such as Regulatory Affairs, Medical Affairs and PMO.

Position Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
General responsibilities for this position will include (but are not limited to) the following:

Business Partnership: Build and enhance the business relationship with different stakeholders within the Development Organization – specifically Regulatory Affairs, Medical Affairs & PMO

Technology Development, Delivery & Operations: Maintain and enhance the technology roadmap based on DT operating model; Execute the Tech Roadmap initiatives in adherence to planned timelines, budgets, compliance and security standards. Deploy and support implemented capabilities.

Business Knowledge/Business Process mapping/Cloud Platform expertise:
• As Product Owner of portfolio of products, you will gather feature requests, schedule releases, and coordinate sprints. You should be able to identify user needs, help a customer understand a business value and work with cross-functional teams to manage product releases.
• You will need to deliver products not just according to users, but the product(s) that makes Exelixis Digital Transformation vision a reality.
• Work with internal and external customers to analyze the needs and align product roadmap to strategic goals.
• Develop scope and define backlog items (epics/features/user stories) that guide the Agile product development team.
• Draft key objectives and results, strategies and apply the data for the product to make business decisions.
• Possess a fundamental understanding of end-to-end customer experience integration and dependencies.
• Act as an ambassador for the product(s) internally and externally and as the primary contact for queries related to the product(s).

SUPERVISORY RESPONSIBILITIES:
• Provide direction to other individuals.
• Supervises staff, including hiring, scheduling and assigning work, reviewing performance, and
recommends salary increases, promotions, transfers, demotions, or terminations.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
• Bachelor’s degree in related discipline + twelve years of related experience; or
• Master’s degree in related discipline and ten years of related experience; or
• PhD degree in related discipline and eight years of related experience; or
• Equivalent combination of education and experience.

Experience
• Minimum of 12 years of work experience in an IT Leadership and Account Management role in the Pharmaceutical/Biotech industry, with a focus in Clinical Drug Development
• Minimum of 8 years of experience at the intersection of strategy, architecture and innovation, applying advanced technologies to large and/or complex business problems
• 5+ years of experience with implementing Agile practices in the Pharmaceutical industry.
• Experience leading, managing and building high performance teams
• Experience is required in the areas of technology strategy, product design, engineering, platforms, data architecture, and analytics.
• Experience with Agile, Scrum methodologies and DevOps. Cloud certifications and AWS experience is highly desired.
• Experience working on various Pharmaceutical Clinical Development systems focused in the Reg Affairs & Medical Affairs area such as OmniView, OmniFile, Veeva RIM, Documentum, Open Text, Veeva CRM, Medical Content (Veeva Promo-mats), Medical Communications, HEOR, Library services, Resource & Program planning tools.
• Experience working with SaaS applications and monitoring service levels and deployment schedules
• Entrepreneurship skills, Product and Financial Management.

Knowledge/Skills:
• Working knowledge of various solution delivery methodologies – waterfall, agile, hybrid methods, etc.
• Working knowledge of applied IT architecture in the effective design of business-enabling solutions
• Solid understanding of IT governance, inspection, compliance, and regulatory requirements for validated systems
• Demonstrated relationship savvy in building effective trusted advisor relationships with business partners and IT alike using effective relationship-building, negotiation, mediation and influencing skills
• Ability to lead and manage under conditions of ambiguity and uncertainty
• Proven organizational savvy in working across organizational boundaries and reporting lines - ability to work in a matrix environment is needed
• Demonstrated discipline, analytical skills, problem-solving abilities, and attention to detail
• Independent, self-motivated, self-managing, proactive and responsive with a bias for action and results

WORKING CONDITIONS:
G&A and Development/Alameda:
• Environment: primarily working indoors, performing clerical work

Apply Now!

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.

Published
November 19, 2021
Location
1851 Harbor Bay Pkwy, Alameda, CA 94502, Alameda, California
Category
Medtech  
Job Type
Only registered members can apply for jobs.
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