The role of the Validation Engineer, located in San Francisco, is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual to  work with delivery units to advance existing emerging business critical technology according to Roche Pharma needs. 

The selected candidate will be responsible to:

Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).  This includes, but not limited to policies, directives, and Global Informatics standard operating procedures related to the CSV area.

Assemble global feedback on proposed or existing standards and tools and providing recommendations for new guidance/standards or revisions to existing guidance/standards.  

Provide consultation and guidance to delivery and operational units within Pharma IT to provide accurate interpretation of Roche CSV approach and requirements, information concerning regulatory requirements related to CSV in the specified area, updates on changes in the regulatory environment

Assure that processes are established across Pharma IT to support delivery and operations of compliant systems.

Gather and analyze metrics and key performance indicators to identify opportunities for process improvement

Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution

Facilitate and leverage quality practitioners within the delivery units  to identify best practices,  and lead improvement initiatives across functional areas

Identify new training programs and/or revisions to existing training programs and approaches for delivery of training within and outside of Global Informatics

Provide change request control and support for legacy GMP systems 

The primary mission of the Genentech Research & Early Development (gRED) organization is to discover and rigorously assess promising molecule candidates for viable therapeutic benefits. Within the Early Development segment, the Clinical Operations department is responsible for “first in human” Clinical Trials to assess the benefit and risks of a given therapeutic treatment and is embarking on a 3-year technology program to advance their organizational processes and capabilities.

As the gRED IT Tech Lead, your primary responsibilities are to provide modern technical solutions for the complex business needs in Clinical Operations, to contribute and coordinate IT project work and to support the operational technology landscape within the IT organization. You are a great team player, and self-driven individual who works well with other IT professionals towards the common vision of delivering information systems to enable the company to continue providing novel therapeutics for our patients.

Responsibilities:

• To design, develop, test and implement solutions based on customer requirements with an innovative approach.
• Able to work with customers to gather project requirements and can translate them into a functional solution.
• Provides architectural and engineering input in technical aspects of business planning such as program, project or roadmap planning. Collaborate with Global Architects as required.
• Provides deep technical expertise over a broad set of current technologies and mentoring of other team members in these areas. 
• Within project teams, collects and defines requirements, designs, develops, tests and documents final solutions according to Genentech's project management methodology
• Works with validation teams to ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle.
• In an operational setting, manages the deployment of software enhancements, troubleshoots production systems, contributes to root cause analyses and adheres to customer SLAs all while providing excellent customer service
• Works with a variety of in-house developed, commercial off-the-shelf (COTS) and SaaS software, across the globe, that provide organizational capabilities to manage Clinical Trials
• Experienced with web programming languages such as HTML, CSS, XML, PHP, Python, Perl and Java on Linux and Windows varieties.
• Experience with Business Intelligence and data warehousing solutions including Oracle databases, Informatica ETL, Business Objects and  Roambi mobile reports.
• Experience with Enterprise solutions including Google Apps, Livelink, Sharepoint, Jive SBS and iOS mobile applications.
• Collaborates with internal and external business partners and can lead contractors and vendors in design, development and testing activities.

Position Summary:

The Commercial Control System Lifecycle Management function of MMTech at Genentech has an open position for a QC Scientist/Senior QC Scientist to support lifecycle management of commercial biologics control systems.  This position is part of a function responsible for developing and implementing strategies to systematically evaluate and update control systems for the Genentech/Roche product portfolio.   

MMTech is part of the Genentech/Roche commercial quality organization and is responsible for method validation, control systems and specifications, reference standards, assay transfers, and providing scientific/technical support for the global QC Network across the commercial biotechnology product portfolio.

Job Description:

The individual will support the development, implementation, and maintenance of strategies to systematically assess and update commercial product control systems.  He/she will manage product, process, and external knowledge to ensure that control systems reflect current product and process understanding, analytical technologies, and Health Authority expectations.  The individual will be responsible for contributing to reports that document information supporting control system assessments and revisions.

As part of the control system evaluation and revision, this individual will:

• Oversee comprehensive control system assessments based on: identification of critical quality attributes, method and process capabilities, current industry practices, and contemporary Health Authority expectations
• Lead cross functional technical teams that perform detailed physicochemical characterization, method development/validation, and sample testing so that control system revisions are effectively managed and aligned with present-day requirements
• Provide scientific input and technical oversight to support control system changes
• Partner with subject matter experts to identify and complete key activities required for control system updates
• Collect and analyze results from product release and stability testing for use in evaluating and updating specification acceptance criteria
• Provide technical review and approval of analytical control system cGMP documents
• Support and coordinate quality assurance activities/reviews in Quality systems (e.g. Change Control, Discrepancy Management, etc.) to ensure compliance to procedures, current GMPs, and regulatory requirements
• Support regulatory submissions and inspections through authorship of relevant CMC sections, written responses to agency requests, and direct interactions with Health Authorities

Applicants should be comfortable working both independently and collaboratively as part of a team. The position offers opportunities for professional and scientific growth in a dynamic work environment.

E2/E3 position depending on experience of candidate.

Perform microbiological testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples to meet standard lead times.  Review data and assess against established acceptance criteria.  Identify discrepancies, participate in quality investigations and CAPA initiatives as needed.  Participate in assay, facility, equipment and process validation. Perform equipment qualification and maintenance activities.  Support nonroutine microbiological projects and studies.  Prepare and maintain standards, controls and stock cultures per established protocols.  Support the maintenance and compliance of operational areas.  Assure strict adherence to cGMPs throughout operation.  Ensure training qualifications are up to date.  Identify and support resolution of technical problems.  Actively participate in group projects and process improvements.  Perform routine maintenance duties to ensure inspection ready state.  Draft protocols and reports under supervision.  Work with internal and external groups to develop methods for clinical products for in process and final products testing.

Location: San Francisco

Research, Facilities, and Procurement Services

Primary Purpose of Job (Job Summary)

The Category/Souring Manager, Facilities Procurement is to provide strategic leadership to the Facilities Procurement organization in support of Global Categories related to Facility Operations and Services.  This position is responsible for: establishing full strategic planning (Regionally and interfacing Globally) on behalf of the Facilities Procurement function in alignment with the Pharma Business and Corporate goals and objectives; identifying and introducing best practices in the Facility Procurement processes; acting as a change agent who supports and influences the business in an effort to create value and efficiencies across the Global and NA Regional networks; focusing on return on investment benefits, Category Lifecycle Management and Total Cost of Ownership; evaluating savings opportunities in partnership with key business partners and stakeholders and maximizing the value of third-party services across a portfolio of sub-categories.  The Global/Regional Category Manager will lead cross functional teams through strategic category sourcing to deliver breakthrough business benefits.

Functional Roles & Responsibilities

The Global/Regional Category Manager, Facilities Procurement will have a Category Strategic and Supplier Management focus of assigned Global/Regional Categories related to Facility Operations and Services.  This position leverages category management expertise to manage the purchases of goods and services, with the aim of achieving optimal total cost of ownership.  This position provides end-to-end strategic solutions, from idea generation through to presentation to senior business management and initiative execution and will fully utilize the eSourcing tools including eAuctions when appropriate to drive the costs down and out across the assigned categories.

Responsibilities:

* Develop strong working relationships with internal teams, key business partners and leaders throughout the Global and Regional organizations/networks.  

* Partner with global colleagues to develop and implement the global category management roadmap.

* Build and maintain excellent relationships with key affiliates, Roche group companies, and global functions so that Roche collectively benefits (e.g. global savings, service delivery, vendor selection, etc.).

* Partnering with stakeholders and business partners to identify and support sourcing projects that reduce risk, timeline, stakeholder pain-points or cost and add value without sacrificing quality or effectiveness.

* Lead and/or partner with various multifunctional teams on strategic initiatives which also include accountability for implementation planning and tracking of expected outcomes.

* Aligning the priorities, activities, and progress of goals across the Facilities organization, so that high value and quality customer service is delivered.

* Provide Strategic Category and Supplier Management:

o Develop an advanced understanding of category subject matters to include Analyzing Category and Supplier Spend history, trends and forecasts

o Establish and manage robust Supplier Relationship Management programs for Strategic/Key suppliers

o Lead Category activities and Sourcing Managers in the development and execution of the spend category sourcing strategies for key initiatives.

o Develop detailed supplier knowledge, market data, including financial performance (P&L, balance sheet, debt structures, trends, history, executives, ownership, parent companies, size, concentration of sales to GNE, diversity of sales volume)

o Analyze past and future demand volumes, inventory trends and current inventory levels

o Document supply-chain for key goods and services

o Identify opportunities that focus on cost reductions, efficiencies/quality improvements, risk mitigation, industry and supply trends and shifts in technology

o Lead sourcing projects including sourcing strategy development, market analysis, and supplier negotiations, and supplier relationship management

o Monitor Strategic/key Suppliers (earnings, SEC filings, RSS feeds, Alerts) to provide internal notifications to key stakeholders that includes developing risk mitigation scenarios

o Ensure Diversity Suppliers are included in sourcing events

o Know, understand and stay abreast of industry trends, benchmarks, best practices, etc.  Develop and implement a strategy to gain competitive advantage.

* Facilitate senior level review and concurrence on sourcing strategies, including sponsorship and resource allocations.

* Demonstrate advanced industry knowledge and facilitation skills so that this role leads the negotiations of contractual requirements that includes managing complex RFP/RFIs, making sele...

We seek a highly motivated Scientist / Sr. Scientist to lead biomarker development efforts in support of Genentech’s Oncology pipeline. The incumbent will lead a small laboratory group focusing on predictive and pharmacodynamic biomarker development efforts, as well as lead and support biomarker subteams for programs in clinical development. All of the Scientists in OBD are encouraged to develop a focus in one of several areas that advance our understanding of specific diseases or enable advanced biomarker assessments through exploration of innovative, cutting-edge technologies.  For this particular position, a strong background in cancer cell signaling and cancer genomics, evidenced by peer reviewed publications in top tier journals, is required.  Practical experience with predictive or pharmacodynamic biomarker development in an industry setting would be an important asset.  The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences.

As a Scientist / Sr. Scientist, you are expected to:

• Provide exceptional scientific leadership within OBD, as well as to other functions, subteams / teams at Genentech / Roche
• Develop and effectively manage a small laboratory group, predominantly focused on scientific support for molecule programs
• Drive scientific and technical innovation collaboratively with other members of the Department
• Lead one or more biomarker subteams
• Develop and execute on lead and exploratory biomarker strategies for one or more projects
• Participate in, or lead, disease focused translational biomarker programs, or develop a key focus on novel technologies that advance clinical biomarker assessment
• Publish in high quality scientific, technical or medical journals
• Represent OBD externally through presentations at key National / International meetings, interactions with our key investigators
• Participate and thrive in an interactive, team oriented culture

We seek a highly motivated Scientist / Sr. Scientist to lead biomarker development efforts in support of Genentech's Oncology pipeline. The incumbent will lead a small laboratory group focusing on predictive and/or pharmacodynamic biomarker development efforts, as well as lead and support biomarker subteams for programs in clinical development.

All of the Scientists in OBD are encouraged to develop a focus in one of several areas that advance our understanding of specific diseases or enable advanced biomarker assessments through exploration of innovative, cutting-edge technologies.

For this particular position, a strong background in cancer immunotherapy or the biology of the tumor microenvironment, evidenced by peer reviewed publications in top tier journals, would be an important asset. The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences.

As a Scientist / Sr. Scientist, you are expected to:

• Provide exceptional scientific leadership within OBD, as well as to other functions, subteams / teams at Genentech / Roche Develop and effectively manage a small laboratory group, predominantly focused on scientific support for molecule programs
• Drive scientific and technical innovation collaboratively with other members of the Department Lead one or more biomarker subteams
• Develop and execute on lead and exploratory biomarker strategies for one or more projects
• Participate in, or lead, disease focused translational biomarker programs, or develop a key focus on novel technologies that advance clinical biomarker assessment
• Publish in high quality scientific, technical or medical journals
• Represent OBD externally through presentations at key National / International meetings, interactions with our key investigators
• Participate and thrive in an interactive, team oriented culture

The Discovery Oncology department is seeking an exceptional and highly motivated scientist to join a team focused on the discovery and validation of novel oncology drug targets and the discovery of biomarkers predictive of the clinical efficacy of novel cancer therapeutics. Current efforts of this team are largely directed to developing a mechanistic understanding of tumor cell sensitivity and resistance to molecularly-targeted anti-cancer agents. Aspects of cancer cell biology of particular interest include epigenetic regulation and intra-tumor heterogeneity.

Position: Principal Business Process Excellence

Location: Basel or South San Francisco

Summary:

Team Overview:

The Business Process Excellence (BPE) team is focused on enabling GPP to achieve Best in Class Performance by taking the lead in the creation and improvement of scalable, robust, and streamlined processes.  Intent is to enable GPP’s Strategy and build robust process capabilities that manifest through the routine delivery of exceptional performance as per business needs. The BPE group partners with the business to deliver business results focused on establishing and improving business processes to improve reliability, increase simplicity, and enable growth. We use a several tools and methodologies within but not limited to Business Process Excellence toolkit to deliver tangible and sustainable business results. 

Position Overview:

This position focuses on using Business Process Excellence methodology to perform business process analysis, design/re-design and optimization to enable the routine delivery of exceptional operational performance

Reporting to the Head of Business Process Excellence - Global Pharma Procurement (GPP), the Principal- Business Process Excellence (BPE) will champion embedding Business Process Excellence across the entire GPP organization and ensuring our organization achieves its vision of becoming the Best in Class within the industry. Person will be simultaneously in a strategic and global execution role to support GPP’s journey towards the Best in Class performance.  Incumbent will partner with clients across GPP & PT on a regular basis, drive BPE cultural change and build BPE capabilities at grass root as well as leadership level.  

Responsibilities: 

This individual will be responsible for leading global cross-functional process improvement projects, representing the department as the change agent, partnering with the customers, leading internal efforts within the team, communicating/coordinating/bringing together key stakeholders, resolving conflicts within the team, and delivering real value-add sustainable cross-functional solutions. This individual will mentor project team members and staff in best practices associated with industry and BPE methodologies. This individual will be accountable for following and improving upon the BPE methodology. The work will be done in alignment with the company's values and behaviors. 

Requirements: 

* Lead cross functional project teams to: -Create solutions to ensure a continuous improvement culture, including behaviors and measurements using BPE methodology

* Implement practical and sustainable business processes that best serve the business unit -Deliver project goals on budget and on schedule

* Develop conceptual customer needs into an approved project charter

* Analyze business, process and systems performance, and identify improvement opportunities -Identify opportunities for team members to develop, evaluate and manage business case and cost/benefit analyses

* Make recommendations to Senior Management based on business case and analyses

* Lead decision making support and make recommendations regarding best options -Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution

* Develop and use project plans to coordinate participants and track and report progress -Leverage industry research and analysis; serve as advocate, mentor & role model for integrating best practices into the organization -Ensure improvement methodology and tools are utilized effectively to maximize benefits

* Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals 

Competencies:

* Ability to influence with or without direct reports, facilitate groups with diverse perspectives, bring teams to the best solutions. High tolerance for ambiguity, able to create order from chaos. 

* Takes accountability for actions, drives results, and learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly. Asks "what can I do to help?” 

*  Ability to communicate effectively up and down, at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity. 

* Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amount of information. Able to deliver results despite shifting environment.

* Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigatio...

Director of Portfolio, Project & Process Excellence 

Location:  San Francisco, CA OR Basel, Switzerland

Purpose

* This leadership role is responsible for leading a team of leaders in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and has full accountability for driving global prioritization of our GPP portfolio and ensures the effective management of our transformation projects through excellence in project management and efficient processes.

* This leader is responsible for connecting together one GPP project portfolio that includes all GPP projects and ongoing resource management.

* Accountable for the Lean Six Sigma infrastructure by building short and long-term capabilities within GPP to meet the vision of becoming the best procurement team in our industry. 

* Partners closely with stakeholders and customers to collaborate, influence and execute on project and  Business Process Excellence across the entire organization.

Key Relationships

* GPPLT – final portfolio decision maker

* GPP Functional Leaders – functional portfolios feed into GPP portfolio; support BPE projects

* GPP Operations - Support the S2P Business process owners through continuous improvement

* Provide BPE expertise to business partners to support improvement to their processes

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages 5 direct reports, with a team of 15-20 employees and contractors.

* Oversight of the GPP Portfolio, Business Process Excellence, Project Management function and dedicated Project Communications support.

* Portfolio:  Prioritizes portfolio projects for GPP globally including resourcing and solution management.  

* Identify and prioritize strategic and operational initiatives to improve GPP’s performance along financial (savings), customer, process and people dimensions. 

* Prioritize the overall GPP IT Solution management and roadmap including maintenance and enhancements.

* Project: Develops a consistent stage gate review process to ensure all projects are set for realization of their intent and sponsorship.

* BPE and Project Support:  Provides vision and guidance to effectively support business process excellence – through achievement, sustainment and ongoing realization of business process management.  Ensure a robust infrastructure to support effective, efficient, innovative and agile operations. 

* Ensures projects achieves its intended realization.  Support overall change execution through the BPE tool kit.

* Builds BPE/OE capabilities and mindset within the network to empower others to make improvements on their own. Train others in the continuous improvement tools and techniques found in the BPE/OE toolkit.

* Communications:  Ensures GPP project and portfolio communications are aligned and connected to the overall GPP communication strategy. 

Sr. Manager, Promotional Services

Location:  San Francisco, CA

Job Description

1. Compliance, Knowledge & Skills

o Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these

o Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals

o Asks questions when in doubt

o Demonstrates leadership among peers by consistent application and modeling of the appropriate compliance, behavior and conduct

o Where applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

2.  Team Leadership & Development

o Sets short and long term goals, vision and strategy for the team

o Plans & implements an aligned team structure with clear roles & responsibilities and ensures the appointment/placement of appropriately skilled/qualified team members to meet the different needs/roles within the team

o Hires, develops and retains talent on the team; ensuring alignment of hiring in relation to team structure requirements to help fulfill/meet departmental plans and objectives both in the immediate sense and over time/building for the future

o Ensures direct reports are developed to expand their skills and abilities, as well as relevant product and surrounding marketplace knowledge

o Proactively manages team performance, giving direct, clear, open & honest feedback, as well as recognizing and rewarding successes. Ensures any indirect reports are also regularly appraised of performance feedback. Complies, and ensures the same for any indirect reports, with all company policies & procedures in terms of formal performance feedback & reviews

o Acts rapidly, appropriately, decisively and consistently in cases of observed or reported potential policy violations. Is guided by company policies and procedures

o Ensures team members have access to needed resources and information that will enable them to perform their roles/responsibilities to the best of their abilities. 

o Provides direction, coaching, feedback and guidance to help ensure the team meets or exceeds assigned goals and objectives

o Leads by example in developing personal technical and leadership skills and ensures team members participate in similar opportunities

3.  Planning & Development

o Ensures team and self stay abreast of internal and external changes and evolutions: Genentech business strategies, goals and objectives, market and industry trends, as well as legal and regulatory developments and requirements

o Works with direct reports, brand teams across all Genentech Commercial business units, and external advertising agencies to proactively review and plan for upcoming promotional communication strategy requirements:

* Assigns team member responsibilities by Genentech business unit and/or Genentech brands

* Contributes to strategies around scope, content, order volume, artwork, quality, compliance and other project management direction, requirements and terms

* Plays a leadership role in managing external vendor selection process and programs

* Develops key content for all RFP documentation, including detailed requirements for promotional services as well as process for competitive bidding and selection

* Takes the lead departmental role in identifying and recommending opportunities to optimize their investment

* Ensures the team is meeting the needs of the commercial organization

o Responsible for ensuring streamlined departmental practices, procedures, systems and tools:

* Defines internal workflows and processes; includes development and implementation of DOPs (Department Operating Procedures) 

* Defines all roles and responsibilities across team

* Identifies, recommends and oversees the development of departmental systems and tracking tools, such as digital asset management system, gPrint, etc.

* Defines departmental performance metrics and standards, such as key performance indicators that enable the department and its internal customers to measure effectiveness and efficiencies

o Analyzes and makes recommendations regarding workload balance and required resources and other infrastructure needs to fulfill all project management responsibilities, goals and objectives across all Genentech business units

o Identifies, leads and/or assigns special, other departmental projects, as and when appropriate

o Leads the discovery process of new innovative solutions to the stakeholders that the team will take on as a priority 

4. Project Management & Operations

* Acts as lead industry expert for promotional communications stra...

Category Lifecycle Process Leader, Director of Procurement

Location:  San Francisco or Basel

Purpose

* This leadership role is responsible for leading a team in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable for design and delivery of the global category management process. 

* This leader has strategic accountability for the overall category management process for GPP, and must work with SRO leaders to ensure the process connects to the Source to Pay Process. 

* Key accountabilities include creation of a GPP category management tool kit and sourcing, supplier relationship management and governance processes.

* This leader will be responsible for creating and implementing an overall outsourcing process, strategic framework and governance management, which will require engagement with GPPLT and key business leaders. 

* This leader will be responsible for creating and implementing the Global eSourcing Program to establish eSourcing as way of working across GPP. 

* Drives sustainable savings and eSourcing process automation across affiliates, sites & GPP functions through partnership and collaboration.

Key Relationships

* GPPLT, and functional teams

* GPP business process owners

* Affiliate Procurement Leaders

* Global/Regional/Affiliate Finance Leaders

* IT and the S2P Steering Committee

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages 4-5 direct reports with total team of 10-15 employees and contractors .  Expand to 6 direct reports as Outsourcing Strategy and governance is established.

* Ensures the application of the GPP Category Management process is robust and established as a way of working through the Global Pharma Procurement functions. 

* Establishes and manages the Outsourcing process and strategy governance.

* Manages the connection through the coordination of the overall Procurement Processes of Category Lifecycle including Category Management, Contracting, Request to Pay and Master Data processes.   

* Manages the global category management process ensuring toolkit application and practice for both indirect and direct materials processes.  

* Manages process content and training materials for the category management and eSourcing processes.

* Establish and governs the Supplier relationship management and governance processes for GPP categories.

* Owner of the eSourcing Process:  Including improvements, system (IT Solution), Delivery of support and project portfolio.

* Sets up the eSourcing regional support model to support end to end eSourcing processes.

* Drives the adoption of eSourcing tool and processes globally.  

* Raises usage of eSourcing to increase effectiveness (deeper value) and efficiency (faster cycle time) through the use of eSourcing.

* Establishes and monitor global eSourcing targets in conjunction with savings targets.

* Identify eSourcing opportunities in conjunction with the GPP Categories.

* Manages sourcing project content and strategy including: project and bidding strategy, spend segmentation, recommendations for savings implementation, tender development (RFI, RFP, RFQ, auction formats) and managing multiple site project teams.

Product Manager / Senior Product Manager 

 
Managed Care Marketing (MCM) supports Genentech’s business by designing managed care marketing strategies, plans and programs for Genentech’s pipeline and in-line portfolio that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices).

For pipeline products, MCM supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch. Senior Product Managers are generally responsible for multiple molecules at various stages of development.

For in-line products, Senior Product Managers act as a primary liaison to managed care account managers (for payer and channel customers) and field reimbursement managers (FRM) (for practices) and may have matrix responsibilities to represent MCM for one or more products or franchises.
 
Product Manager / Senior Product Manager responsibilities may include:

Overall

• Creates and delivers managed care marketing strategies and programs; manages relevant agencies and budgets
• Works with US and/or Global cross-functional groups to ensure a seamless and well-integrated messages and overall positioning across multiple marketing platforms
• Aligns therapeutic area and managed care marketing strategies and tactics with pricing, reimbursement, contracting, distribution and other relevant functions
• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year brand strategies and tactical plans
• Educates internal partners and stakeholders on the US managed care landscape and its implications to current and future managed care marketing strategies, plans and objectives
• Continuously refines knowledge of internal and external business drivers of the managed care landscape and their implications for Genentech
• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall results
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

For pipeline molecules

• Leads managed care strategic planning to contribute to Phase III drug development investment decisions, trial design, and overall value proposition
• Builds, implements and manages the managed care marketing plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (as relevant)

For in-line products

• Acts as a key liaison to managed care customer-facing teams and to relevant brand teams
• Works with various MCCO account management teams to effectively and efficiently apply branded and non-branded promotional resources or other relevant resources to accounts, as appropriate 
• Provides strategic consultation to account management-led account planning
• Reviews and assesses cross-functional business strategies, plans and tactics; recommends managed care marketing strategies, plans and activities that support optimal positioning and reimbursement of and access to Genentech medicines
• Creates and manages 3-year and 1-year managed care marketing strategies, plans, and tactics for specific managed care segments
• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives.

Senior Director, Contracts Process and Operations 

Location:  San Francisco

* This leadership role is responsible for leading a team of leaders in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable  as the global contracts business process owner to ensure optimal GPP value delivery to our business partners.   

* This leader will be leading an organization that is bringing together all GPP contracts teams into one function to leverage best practices and align with the GPP Go Simple project to streamline contracting processes within GPP.  

* This leader has strategic accountability for activities associated with development and execution of contract agreements for all GPP customer groups globally (Product Development, Research, Technical Operations, Global Product Strategy, US Commercial and US Site Services) 

* This leader is the primary liaison with senior leaders in various GPP client groups and US/EU legal organizations and must be able to effectively influence senior leaders

* Accountable for appropriately managing legal and compliance risk on behalf of Roche in the execution of the contractual process including negotiations of terms and conditions. 

* This leader is accountable for connecting the Contracts process to solutions (IT) and service delivery.

Key Relationships

• Internal: Provides guidance and mentoring to Contracts staff members in contract development and administration and working effectively with Genentech user community and vendors

• Business Partners 

• External: Seeks out industry benchmarks

• IT and the S2P Steering Committee

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages  6 direct reports and manage a team over 110 employees and contractors.

* Responsible for developing and implementing contract processes and managing a group of professional contract staff globally representing all GPP functions.

*  Ensures that a wide variety of company contracts are negotiated and processed to meet the needs of multiple client groups.

* Manages the contract process from initial request to contract execution, focuses on agreements with complex legal and business risk.

* Actively manages the GPP Contract process and support the connection to the overall Procurement Processes of Category Management, Contracting, Request to Pay and Master Data processes. 

* Ensures all policies that govern the conduct of contracting activities are adhered to in accordance with all legal policies globally

* Works with Roche/Genentech user community to ensure there is a complete understanding of contract requirements.

* Works with direct reports, other team members, and various internal business partners to review contract service levels and performance.

* Participates in process improvement or other projects that enhance and streamline contracting processes, systems, tools and other resources; collaborates legal departments to improve contract templates and processes.

* Provides direction and training to teams regarding good business procedures and contract business terms; shares best practices and feedback on contract and budget matters to Contracts staff and  GPP teams.

* Identifies and manages areas of risk and compliance both in the establishment of contracts and in the operation of the contracts and the relationship with the outside vendor.

The Preclinical and Translational PK/PD Department at Genentech,Inc. is seeking a Ph.D. level scientist who is driven to understand the pharmacokineticsand pharmacodynamics of novel drug candidates with a focus on proteintherapeutics including antibody drug conjugates. This individual will beresponsible for investigating the pharmacokinetics, biodistribution, and PKPDrelationships of novel therapeutics in preclinical models to identify leadcandidates for further development, and for all relevant translational aspectsbridging preclinical PKPD information to patients. This individual will beresponsible for the PK and PKPD strategy to support preclinical development andfirst in human regulatory filings, including planning, designing, analyzing, interpretingand reporting PK and PKPD studies. This will be accomplished by working inclose partnerships across various functions including Research, DevelopmentSciences, Clinical Sciences, Biostatistics, and Regulatory. This individualwill represent the department on cross functional project teams as the PKPDrepresentative and/or pharmacology sub-team leader. An additional componentwill be the presentation of PK/PD results at cross-functional teams, departmentmeetings, review committees, conferences and regulatory meetings.

• Acts as a subject matter expert and specialist point-of-contact for internal staff and management and external vendors involved in the distribution and/or administration of Genentech promotional goods:

• Receives and reviews all incoming requests/inquiries
• Reviews incoming promotional goods requests or other inquires in accordance with governing rules, regulations or other policies and procedures to ensure consistent and full compliance
• Provides timely responses and other information to internal and external customers, partners and other stakeholders
• Enters all requests and other information into appropriate departmental or other systems or databases
• Responsible to ensure that departmental systems and/or databases contain current and fully accurate information
• Performs routine and ad hoc analyses and reporting

• In partnership with Vendor Manger, visits promotional goods vendors and
• performs compliance and other operational audits
• Performs routine and ad hoc audits on promotional goods distribution managed by Genentech field staff and management
• Produces audit reports. Reviews with manager and others. Distributes to various parties.  Identifies and communicates potential or existing issues and recommends steps and activities to mitigate risks of non-compliance or other potential concerns
• As and when appropriate, participates in various meetings or conference calls to determine promotional goods needs, requirements, and/or communicate new or updated regulations, policies, procedures or other changes
• Supports manager and other team members, as and when/how needed, to cover for any staff shortages within the department
• Works with manager and other team members to continuously review department processes, procedures, tools and other resources to ensure best practices, optimal efficiencies and effectiveness
• Supports his/her manager and other team members in ongoing training, mentoring and coaching of less experienced analysts
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

Purpose: 

The Safety Science Leader (SSL) is accountable for all aspects of safety related to a product in the Life Cycle Team (LCT) stage including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate. Accountability is partially exerted by the bringing of safety topics to the Development Subteam (DST) and, when appropriate, the Life Cycle Team (LCT) to ensure that adequate safety measures are implemented, based on data, and that CIOMS 6 guidelines are followed. 

Primary Responsibilities and Accountabilities:

• Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. 
• Reviews all communications to the public from a safety point of view. 
• Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. 
• With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.
• Is accountable for safety components of all NDA documents. 
• Is responsible for the writing and maintenance of RMP/REMS NDA documents. 
• Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.  
• Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS 
• Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates. 

People Leadership: 

• Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. 
• Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.  
• Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.
• Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. 
• Actively installs the Roche values in the Safety Team and their activities.