Capability Manager, Clinical Supply & CMO Collaboration- PDM

Location
Foster City
Salary
See job description.
Posted
June 08 2021
Ref
R0017715
Position Type
Full Time
Organization Type
Pharma
Job Type
Other


Capability Manager, Clinical Supply & CMO Collaboration- PDM
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs
in medicine for more than three decades, with the goal of creating a healthier world for all people.
The company is committed to pursuing scientific invention to prevent and treat life-threatening
diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries
worldwide, with headquarters in Foster City, California.

You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are
a close community where every individual matters and everyone has a chance to enhance their skills
through ongoing development. Inclusion is one of our core values, which means we are creating and
fostering a work environment where our differences are valued, and everyone feels respected and
empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to
discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

Specific Responsibilities and Skills

The R&D / PDM group within IT department is responsible for working with functional business partners in the design, build, deployment, and support of business applications globally. The Capability manager in conjunction with DevOps Lead and Global capability lead work together to deliver against set business objectives and have measured outcomes- typically leading the applications-related business and technology workstreams. R&D / PDM group also works closely with other cross-functional groups within IT namely Security, Worldwide Infrastructure Operations, and Enterprise Platform teams in the delivery of these capabilities leveraging Systems Life cycle (SLC) methodologies. The PDM Capability Manager will be responsible for business capabilities in the areas related to Pharmaceutical Development and Manufacturing areas - Clinical Supply Chain and CMO Collaboration domain. The Capability Manager will support the development of the business vision and capability map for the PDM business. This individual works with the business on its strategic requirements and is responsible for the delivery and sustainment of the end to end customer experience. This role specifically requires strong management and leadership experience to work with the devops lead and functional business partners in the design, deployment, and support of business applications supporting the PDM space. The capability manager is responsible for the ideation, planning, development oversight of one or more business or information technology capabilities. Participates in short and long-term business or IT strategic planning sessions, identifying opportunities, and making recommendations for the enablement of capabilities. Leads the analysis efforts for business case development, including resource estimates, prioritization, and categorization. Advises on options, risks, costs versus benefits, and impacts on end-user, processes, and system priorities. Collaborates with functional stakeholders and technical resources to cultivate technology solutions aligned with business or IT strategies. Establishes and maintains a strategic relationship with functional level stakeholders.

Essential Duties and Job Functions

General responsibilities for this position will include (but are not limited to) the following:
  • Accountable for the Clinical Supply Chain and CMO Collaboration capability
  • Participates in short- and long-term strategic planning session to improve business or IT processes through capability development
  • Analyzes business or IT operations to understand their strengths and weaknesses to determine opportunities for improvements through capability enablement
  • Demonstrates how capability enablement can assist departments/business areas and how platforms and solutions can support the achievement of short- and long-term business or IT capability goals
  • Establishes and maintains a strategic relationship with functional level stakeholders
  • Development of business cases, cost structure, and ROI model in support of investment projects and activities demonstrating clarity on how the solution provides business value
  • Actively communicates with business, IT and other stakeholders, to ensure awareness of vision, roadmap, progress, risks, and results associated with a key capability
  • Works with appropriate stakeholders to proactively identify and evaluate risks associated with business decisions that may impact a capability enablement
  • Confirms the business or IT need is addressed by the technical solution from a capability point of view
  • 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
  • Proven experience with leading and overseeing teams on the roadmap implementation to enable capabilities for the Clinical Supply Chain and CMO Collaboration platforms
  • Communicates to other IT domains for awareness of key capability aspects, how they operate and how they are impacted.
  • Communicates broadly and maintains awareness of projects or changes to other systems that may impact enterprise systems to ensure there is no degradation of service.
  • Fosters a team environment and mentors members of IT team
  • Partner with DevOps Lead and global capability lead and Portfolio lead to create the business case and Deliver the Projects to support Business strategy.
  • Partner with Training &; Change Management lead to support a strategy for consistent and timely communication related to supply chain applications and its adoption with its user-base
  • Partner with DevOps Lead and Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope, SLAs, and KPIs.
  • Partner with the DevOps Lead and Technical Manager to capture, analyze and document business requirements
  • Participates in business customer idea elaboration and technical problem-solving with potential technical options including proposals, front-end studies, development plans, and presentations, as needed in a consulting role
  • Accountable for working with Business Process Owner, IT Compliance(for non-GxP systems) or QA (for validated systems) to identify the appropriate System Life Cycle model based on applicable business requirements before presenting estimates for input to new system business case or change implementation plans
  • Leads or assists with scoping, identification of project deliverables, project time estimations, resource level estimations and ensure that the creation of project-specific documentation such as technical specifications are produced
  • Defines technical strategies by performing evaluations, proof of concepts and assessments on the various technical aspects of the proposed project solution
  • Partners with Project Managers (PMs) to develop the technical delivery work plan and schedule and ensures that appropriate technical delivery staffing resources are assigned, and effectively utilized. Works with the Project Manager, BPO, IT
  • Compliance (for non-GxP systems) or Validation Lead (for validated systems or qualified infrastructure) to ensure that the project plan reflects the dependencies and required deliverables of the selected System Life Cycle model
  • Communicates proactively with the Project Manager and project team regarding project status
  • Partners with Quality Assurance (QA), IT Compliance and Validation resources to provide oversight and ensure that issues are properly assigned, fixed, and regressed
  • 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
  • Participates in the creation of Request for Proposals (RFP) from a capability perspective.
  • Partners with external business partners to meet the technical project needs as appropriate
  • Provides business knowledge expertise and mentorship to coach, train and guide new or junior IT staff, such as to suggest training course options
  • Serves as an advocate and endorses and enforces technological best practices in collaboration with solution architects
  • Facilitates and coordinates guidance to IT senior staff, working closely with solution architects, technology leads, DevOps leads and engineers
  • Ensures that business outcomes are met and proper measurements in place.
  • Keeps abreast of industry trends and advancements in relevant technology
  • Partner with Domain Architect, Technology manager, global capability leads and portfolio managers to create the business case and Deliver the Projects to support Business strategy.
  • Support Validation/QA teams on ensuring GxP compliance by leveraging corporate standard for IT change management and IT SOPs following 21 CFR Part 11 and Annex 11 requirements.
  • Excellent interpersonal, communication, and business partnering skills
  • Strategic mindset with a strong analytical foundation
  • Ability to drive continuous improvement across the team
  • Ability to operate in a cross-functional / matrix environment
  • High level of personal integrity consistent with Gilead's core values
  • 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
  • Advises clients/business analysts on discrete technology-related business problems, leveraging appropriate IT colleagues and/or vendors as appropriate. Formulates options including assessing their relative merits and risks, and works with clients/business analysts to determine the best solution.
  • Supervise a team of technical professionals, with full responsibility for performance management.
  • Acts as a technology mentor to team members.


Knowledge, Experience and Skills

Must have demonstrated implementation experience of Clinical Supply and CMO collaboration domain in a Bio-pharmaceutical industry.
  • Must think ahead strategically and must be able to weigh and decide between implementing new functionality by configuration vs assessment of new technology.
  • Demonstrates proficiency with one or more technology environments, with the ability to learn and apply new and emerging concepts very quickly.
  • Good financial acumen, and experience managing financials for large and complex projects
  • Good understanding of GxP compliance and 21 CFR Part 11 requirements.
  • Laser focused and strong experience managing large, matrix, cross functional team.
  • Strong communication, excellent research skills, and learning agility to understand internal business or IT process, best practices and translate into technology needs/opportunities
  • Strong work ethic, a sense of business urgency, and the ability to work effectively with many deadlines in a complex matrix organization
  • Strong business acumen
  • Possesses strong leadership skills and ability to make critical decisions
  • Ability to find innovative ways to resolve problems
  • Strong executive-level verbal and written communications
  • Extensive experience in stakeholder management, dealing with senior management up to executive level
  • Ability to work with dispersed and global teams and locations
  • Excellent at interpersonal skills and relationship development
  • Specific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is preferred
  • Good understanding of GxP compliance and 21 CFR Part 11 requirements.
  • Experience in Life Sciences is a must.


Basic Qualifications
  • High School Degree and Fourteen Year's Experience OR Associates Degree and Twelve Years Experience OR Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD and Two Years' Experience

Preferred Qualifications
  • Experience with Agile, Scrum methodologies
  • Experience working with Computer System Validation in a GxP regulated area
  • Deep understanding of Supply Chain (both Clinical and Commercial)
  • Experience in GxP applications (and Good Documentation Practices) and working in SOX audited environments is a plus.
  • Experienced with functional/technical implementation serialization and supply planning applications based on functional designs.
  • Experience working with SaaS applications and monitoring service levels and deployment schedules
  • Experience leading consultants for delivery and sustainment and ensuring the quality of work delivered
  • Experience handling Change control processes as a gatekeeper.
  • Professional written, verbal, & interpersonal skills
  • Ability to multi-task effectively & work independently
  • Strong Delivery skills, ability to work in a complex environment and an ability to influence cross-functional teams
  • Strong communication skills are a must
  • Experience in GxP applications (and Good Documentation Practices).
  • Have the ability to support mission-critical business solutions using IT as a tool.
  • Experience managing a large group of consultants for delivery and sustainment and ensuring the quality of deliverables
  • Bridges between business and IT, for small/ simple IT systems and projects
  • Track record working in a fast-paced, highly iterative environment
  • Strong Listener: Be able to patiently listen to understand the business needs
  • Communication - Should be able to communicate with business stakeholders and be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and the ability to adapt and learn to changing business environment and domains is a must
  • Experience in Life Sciences is a must.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

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